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Completed

NCT Number: NCT04485325

Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients

Patients with active rheumatic arthritis (RA) and lack of efficacy of at least one csDMARD (Disease-modifying anti-rheumatic drug) treatment will be randomized to receive either Tofacitinib (TOFA) or etanercept (ETA). The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (non-steroidal anti-inflammatory drug) over the first 12 weeks of treatment will be measured for primary outcome measured using a visual analogue scale (VAS) at week 12 compared to baseline between the two treatment groups.

Starting at week 12, the capability to taper corticosteroid (CS) treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups.

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Key information

Conditions

Rheumatic Arthritis Arthritis Bacterial Infections Bacterial Infections and Mycoses Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatic Fever Signs and Symptoms Skin and Connective Tissue Diseases Streptococcal Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Universitätsmedizin Berlin, Med. Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin, Germany

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About this study

In this clinical study, a design was chosen to reflect European standards recommended by EULAR for treatment of active RA by comparison of a Treat-to- target (T2T) approach in two treatment groups: Patients with active RA and lack of efficacy of at least one csDMARD treatment will be randomized to receive either TOFA or ETA. The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (Celecoxib, two times 200 mg as maximum standard dosage for RA) over the first 12 weeks of treatment will be measured for primary outcome. The proportion of patients with successful discontinuation of Celecoxib and significant and clinical relevant decrease of pain-levels measured using a visual analogue scale (VAS) with a reduction of at least 30% at week 12 compared to baseline will be compared between the two treatment groups.

Starting at week 12, the capability to taper CS treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups. In addition to efficacy assessments (DAS28, ACR-response, SJC, TJC), patient reported outcomes, Quality of Life (QoL) measurements and patient satisfaction will be evaluated. Safety (severity and frequency of adverse events) will be evaluated over the 24-week treatment period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with active RA and an inadequate response to up to two previous conventional synthetic Disease modifying anti-rheumatic drug (csDMARD) treatments (methotrexate (MTX), leflunomide (LEF),sulfasalazine (SSZ)) with or without ongoing csDMARD therapy
  • RA according to ACR classification criteria
  • Age 18 - 65 years
  • Active RA is defined as
  • DAS28 > 3.2 and
  • TJC ≥ 3 and SJC ≥ 3
  • VAS-pain ≥ 60 mm (0-100 mm)
  • Accompanying CS treatment for RA with a stable dosage of ≥ 2mg/d and ≤ 10 mg/d 2 weeks prior to BL (not more than 30% of patients without CS)
  • Accompanying need of NSAID or analgesic treatment due to arthritis and in dosages not exceeding the maximum dose according to Summary of Product characteristics (SmPC)
  • If ongoing csDMARD treatment, stable treatment will be defined as either
  • MTX treatment with a dosage of ≥ 10 mg/week and ≤ 25 mg/week, continuously for at least 12 weeks prior to Screening (SCR) with a stable dose of MTX for at least 2 weeks prior to BL or
  • LEF treatment with a dosage between 10 to 20 mg/day, continuously for at least 12 weeks prior to SCR with a stable dose of LEF for at least 2 weeks prior to BL or
  • SSZ treatment with dosage between 1 to 3 g/day, continuously for at least 12 weeks prior to SCR with a stable dose of SSZ for at least 2 weeks prior to BL
  • Presence of documented negative results for testing of Hepatitis B and C
  • Completed SARS-CoV-2-immunisation as currently recommended by the Standing Committee of Vaccination
  • Written informed consent obtained prior to the initiation of any protocol-required procedures
  • Willingness to comply to study procedures and study protocol

Exclusion criteria

  • Previous use of Tofacitinib or other Janus-Kinase (JAK)-inhibitors
  • Previous use of Etanercept
  • Previous use of any biological agent for RA
  • which was stopped due to lack of efficacy
  • one previous use of biological stopped due to intolerance will be allowed
  • CS treatment with dosages >10 mg at BL
  • Known hypersensitivity to any component of the study medication (TOFA, ETA, Celecoxib)
  • Previous use of Celecoxib as analgesic therapy which was stopped due to lack of efficacy or intolerance
  • Concomitant diseases with chronic pain syndrome or need of extended dosages or long-term treatment with the maximum dosages of NSAID/analgesics (according to SmPC) due to other concomitant diseases/pain symptoms in discretion of the treating physician Exclusion criteria related to general health
  • Patients with other chronic inflammatory articular disease or systemic autoimmune disease
  • Patients with active Tuberculosis (Tb) (evaluation of Tb according to local standards in clinical care)
  • Patients with latent Tb, that are not pre-treated for at least 1 month and planned to be treated 9 months in total with Isozid once a day
  • Any active infection, a history of recurrent clinically significant infections (e.g. human immune deficiency virus (HIV)), or a history of recurrent bacterial infections with encapsulated organisms
  • Primary or secondary immunodeficiency
  • Current malignancy or history of malignancies except adequately treated or excised basal cell or squamous cell carcinoma or cervical carcinoma in situ.
  • Patients of 50 years and older, if they have one or more cardiovascular risk factors (CVRF) defined as:
  • Current cigarette smoking,
  • Known diagnosis of hypertension,
  • HDL <40 mg/dl,
  • Diabetes mellitus,
  • History of coronary artery disease: history of revascularization procedure, coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable angina, acute coronary syndrome or
  • History of premature coronary heart disease or sudden death documented in first degree relatives (male relative before 55 years, female relative before 65 years)
  • Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and with the study outcome
  • History of a severe psychological illness or condition
  • Known hypersensitivity to sulfonamides
  • Active peptic ulceration or gastrointestinal (GI) bleeding
  • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs including Cyclooxigenase (COX)-2 inhibitors
  • Risk for or history of thrombotic events (e.g. pulmonary embolism or thrombosis) Severe hepatic dysfunction (serum albumin < 25 g/L or Child-Pugh score ≥ 10)
  • Patients with estimated creatinine clearance < 30 mL/min
  • Inflammatory bowel disease
  • Congestive heart failure (New York Heart Association (NYHA) II-IV)
  • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
  • Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
  • Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, intrauterine device (IUD), physical barrier)
  • Alcohol, drug or chemical abuse Exclusion criteria related to prior treatments
  • Current participation in another interventional clinical trial or participation within the last 90 days Exclusion criteria related to formal aspects
  • Underage or incapable patients

Treatment and study plan

tofacitinib

Drug

5 mg twice daily, p.o.

Other names: TOFA, Xeljanz

etanercept

Biological

50 mg once per week, s.c.

Other names: Enbrel, ETA

Primary outcomes

  1. Discontinuation of Celecoxib treatment and clinically relevant improvement in pain

    Time frame: Baseline to week 12

    Proportion of patients who can discontinue Celecoxib treatment and in whom clinically relevant improvement in pain levels are measured, defined as reduction in VAS pain of ≥ 30%

Secondary outcomes

  1. Mean dosage of Celecoxib in patients

    Time frame: at 12 weeks

    Mean dosage of Celecoxib in patients

  2. discontinuation of CS-treatment

    Time frame: at week 24

    Proportion of patients with discontinuation of CS-treatment at week 24

  3. rescue treatment

    Time frame: at week 12

    Proportion of patients who require rescue treatment at week 12

  4. Mean dosage of Corticosteroids (CS) in the patients who achieve Low Disease activity (LDA) in the two treatment groups

    Time frame: at week 24

    Mean dosage of CS in the patients who achieve LDA at week 24 in the two treatment groups

  5. Mean dosage of Corticosteroids (CS)

    Time frame: at week 24

    Mean dosage of CS at week 24 (W24)

  6. NSAID treatment

    Time frame: at week 24

    Number of patients with NSAID treatment at W24

  7. re-started NSAID treatment

    Time frame: week 12 to week 24

    Proportion of patients who re-started NSAID treatment after week 12 (W12) until W24

  8. Absolute pain levels

    Time frame: at week 2

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  9. Absolute pain levels

    Time frame: at week 4

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  10. Absolute pain levels

    Time frame: at week 8

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  11. Absolute pain levels

    Time frame: at week 12

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  12. Absolute pain levels

    Time frame: at week 16

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  13. Absolute pain levels

    Time frame: at week 20

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  14. Absolute pain levels

    Time frame: at week 24

    Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  15. relative (percent) pain levels

    Time frame: at week 2

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  16. relative (percent) pain levels

    Time frame: at week 4

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  17. relative (percent) pain levels

    Time frame: at week 8

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  18. relative (percent) pain levels

    Time frame: at week 12

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  19. relative (percent) pain levels

    Time frame: at week 16

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  20. relative (percent) pain levels

    Time frame: at week 20

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  21. relative (percent) pain levels

    Time frame: at week 24

    relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  22. Change in pain levels

    Time frame: at week 2

    Change in pain levels measured by visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  23. Change in pain levels

    Time frame: at week 4

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  24. Change in pain levels

    Time frame: at week 8

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  25. Change in pain levels

    Time frame: at week 12

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  26. Change in pain levels

    Time frame: at week 16

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  27. Change in pain levels

    Time frame: at week 20

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  28. Change in pain levels

    Time frame: at week 24

    Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst

  29. Determination of flares

    Time frame: between week 12 and week 24

    Determination of flares (measured by FLARE questionnaire) between week 12 and week 24

  30. Proportion of LDA

    Time frame: at week 4

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

  31. Proportion of LDA

    Time frame: at week 12

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

  32. Proportion of LDA

    Time frame: at week 16

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

  33. Proportion of LDA

    Time frame: at week 20

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

  34. Proportion of LDA

    Time frame: at week 24

    Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)

  35. Proportion of DAS remission

    Time frame: at week 4

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

  36. Proportion of DAS remission

    Time frame: at week 12

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

  37. Proportion of DAS remission

    Time frame: at week 16

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

  38. Proportion of DAS remission

    Time frame: at week 20

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

  39. Proportion of DAS remission

    Time frame: at week 24

    Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)

  40. Proportion of ACR20 response

    Time frame: at week 4

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

  41. Proportion of ACR20 response

    Time frame: at week 12

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

  42. Proportion of ACR20 response

    Time frame: at week 16

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

  43. Proportion of ACR20 response

    Time frame: at week 20

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

  44. Proportion of ACR20 response

    Time frame: at week 24

    Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%

  45. Proportion of ACR 50 response

    Time frame: at week 4

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

  46. Proportion of ACR 50 response

    Time frame: at week 12

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

  47. Proportion of ACR 50 response

    Time frame: at week 16

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

  48. Proportion of ACR 50 response

    Time frame: at week 20

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

  49. Proportion of ACR 50 response

    Time frame: at week 24

    Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%

  50. Proportion of ACR 70 response

    Time frame: at week 4

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

  51. Proportion of ACR 70 response

    Time frame: at week 12

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

  52. Proportion of ACR 70 response

    Time frame: at week 16

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

  53. Proportion of ACR 70 response

    Time frame: at week 20

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

  54. Proportion of ACR 70 response

    Time frame: at week 24

    Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%

  55. Changes in ACR core set

    Time frame: at baseline

    Changes in ACR core set

  56. Changes in ACR core set

    Time frame: at week 4

    Changes in ACR core set

  57. Changes in ACR core set

    Time frame: at week 12

    Changes in ACR core set

  58. Changes in ACR core set

    Time frame: at week 16

    Changes in ACR core set

  59. Changes in ACR core set

    Time frame: at week 20

    Changes in ACR core set

  60. Changes in ACR core set

    Time frame: at week 24

    Changes in ACR core set change

  61. DAS28 (ESR)

    Time frame: at baseline

    DAS28 (ESR) change compared to BL

  62. DAS28 (ESR)

    Time frame: at week 4

    DAS28 (ESR) change compared to BL

  63. DAS28 (ESR)

    Time frame: at week 12

    DAS28 (ESR) change compared to BL

  64. DAS28 (ESR)

    Time frame: at week 16

    DAS28 (ESR) change compared to BL

  65. DAS28 (ESR)

    Time frame: at week 20

    DAS28 (ESR) change compared to BL

  66. DAS28 (ESR)

    Time frame: at week 24

    DAS28 (ESR) change compared to BL

  67. SJC (66),

    Time frame: at baseline

    Swollen joint count (66 joints) change compared to BL

  68. SJC (66),

    Time frame: at week 4

    Swollen joint count (66 joints) change compared to BL

  69. SJC (66),

    Time frame: at week 12

    Swollen joint count (66 joints) change compared to BL

  70. SJC (66),

    Time frame: at week 16

    Swollen joint count (66 joints) change compared to BL

  71. SJC (66),

    Time frame: at week 20

    Swollen joint count (66 joints) change compared to BL

  72. SJC (66),

    Time frame: at week 24

    Swollen joint count (SJC) (66 joints) change compared to BL

  73. TJC (68)

    Time frame: at baseline

    tender joint count (TJC) - 68 joints change compared to BL

  74. TJC (68)

    Time frame: at week 4

    tender joint count (TJC) - 68 joints change compared to BL

  75. TJC (68)

    Time frame: at week 12

    tender joint count (TJC) - 68 joints change compared to BL

  76. TJC (68)

    Time frame: at week 16

    tender joint count (TJC) - 68 joints change compared to BL

  77. TJC (68)

    Time frame: at week 20

    tender joint count (TJC) - 68 joints change compared to BL

  78. TJC (68)

    Time frame: at week 24

    tender joint count (TJC) - 68 joints change compared to BL

  79. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at baseline

    Quality of Life: SF36 scores

  80. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 4

    Quality of Life: SF36 scores.SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  81. Change in Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 4

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  82. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 12

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  83. Change in Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 12

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  84. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 16

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  85. Change in Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 16

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  86. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 20

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  87. Change in Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 20

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  88. Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 24

    Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  89. Change in Quality of Life: SF36 (36 items short form health survey)

    Time frame: at week 24

    Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  90. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at baseline

    Quality of Life HAQ-DI scores The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  91. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 4

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  92. Change in Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 4

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  93. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 12

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  94. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 12

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  95. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 16

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  96. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 16

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  97. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 20

    Quality of Life HAQ-DI scores.The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  98. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 20

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  99. Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 24

    Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  100. Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)

    Time frame: at week 24

    Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).

  101. Correlation of SF36 and HAQ-DI results

    Time frame: through study completion, an average of 24 weeks

    Correlation of SF36 and HAQ-DI results. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do). SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  102. Treatment satisfaction: TSQM-14 scores

    Time frame: at week 4

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

  103. Treatment satisfaction: TSQM-14 scores

    Time frame: at week 12

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

  104. Treatment satisfaction: TSQM-14 scores

    Time frame: at week 16

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

  105. Treatment satisfaction: TSQM-14 scores

    Time frame: at week 24

    Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.

  106. Patient's expectation on treatment

    Time frame: at baseline

    Patient's expectation on treatment asked and documented as free text

  107. Patient's expectation on treatment

    Time frame: at week 12

    Patient's expectation on treatment asked and documented as free text

  108. Patient's expectation on treatment

    Time frame: at week 24

    Patient's expectation on treatment asked and documented as free text

  109. Correlation of TSQM-14 results and patient's expectation on treatment

    Time frame: through study completion, an average of 24 weeks

    Correlation of TSQM-14 results and patient's expectation on treatment

  110. drug accountability

    Time frame: at week 4

    Evaluation of results of treatment adherence (drug accountability) using patient diary

  111. drug accountability

    Time frame: at week 12

    Evaluation of results of treatment adherence (drug accountability) using patient diary

  112. drug accountability

    Time frame: at week 16

    Evaluation of results of treatment adherence (drug accountability) using patient diary

  113. drug accountability

    Time frame: at week 20

    Evaluation of results of treatment adherence (drug accountability) using patient diary

  114. drug accountability

    Time frame: at week 24

    Evaluation of results of treatment adherence (drug accountability) using patient diary

  115. eGFR (estimated glomerular filtration rate)

    Time frame: at baseline

    eGFR value

  116. eGFR (estimated glomerular filtration rate)

    Time frame: at week 4

    eGFR value

  117. change in eGFR (estimated glomerular filtration rate)

    Time frame: at week 4

    eGFR change to BL

  118. eGFR (estimated glomerular filtration rate)

    Time frame: at week 12

    eGFR value

  119. change in eGFR (estimated glomerular filtration rate)

    Time frame: at week 12

    eGFR change to BL

  120. change in eGFR (estimated glomerular filtration rate)

    Time frame: at week 16

    eGFR change to BL

  121. eGFR (estimated glomerular filtration rate)

    Time frame: at week 16

    eGFR value

  122. change in eGFR (estimated glomerular filtration rate)

    Time frame: at week 20

    eGFR change to BL

  123. eGFR (estimated glomerular filtration rate)

    Time frame: at week 24

    eGFR value

  124. change in eGFR (estimated glomerular filtration rate)

    Time frame: at week 24

    eGFR change to BL

  125. blood pressure (mmHg)

    Time frame: at baseline

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  126. blood pressure (mmHg)

    Time frame: at week 4

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  127. change in blood pressure (mmHg)

    Time frame: at week 4

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

  128. blood pressure (mmHg)

    Time frame: at week 12

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  129. change in blood pressure (mmHg)

    Time frame: at week 12

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

  130. blood pressure (mmHg)

    Time frame: at week 16

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  131. change in blood pressure (mmHg)

    Time frame: at week 16

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

  132. blood pressure (mmHg)

    Time frame: at week 20

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  133. change in blood pressure (mmHg)

    Time frame: at week 20

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

  134. blood pressure (mmHg)

    Time frame: at week 24

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure

  135. change in blood pressure (mmHg)

    Time frame: at week 24

    blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL

  136. pain characteristics measured by QST (quantitative sensory testing)

    Time frame: at Baseline

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

  137. pain characteristics measured by QST (quantitative sensory testing)

    Time frame: at week 4

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

  138. pain characteristics measured by QST (quantitative sensory testing)

    Time frame: at week 8

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

  139. pain characteristics measured by QST (quantitative sensory testing)

    Time frame: at week 12

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

  140. pain characteristics measured by QST (quantitative sensory testing)

    Time frame: at week 24

    Correlation of pain characteristics measured by QST, VAS pain and pain relief

  141. adverse events (AEs)

    Time frame: through study completion, an average of 24 weeks

    Documentation of type, frequency and seriousness of adverse events (AEs)

  142. Infections

    Time frame: through study completion, an average of 24 weeks

    Incidence rates of serious infection events (SIEs),

  143. Documentation of all lab abnormalities

    Time frame: through study completion, an average of 24 weeks

    incidence rates of lab abnormalities

  144. Cardiovascular events

    Time frame: through study completion, an average of 24 weeks

    incidence rates of cardio vascular events

  145. Malignencies

    Time frame: through study completion, an average of 24 weeks

    incidence rates of malignancies

Sponsors and collaborators

Lead sponsor

Dr. Frank Behrens

Other

Collaborators

  • Pfizer

Registry information

Official study title

Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)

Acronym: AcceleRAte

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2020
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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