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Completed

NCT Number: NCT04108468

GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA

An investigator-initiated double-blind, parallel-group randomised controlled trial of Methotrexate versus GOLimumab and Methotrexate in very early PsA using clinical and whole body MRI outcomes.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

About this study

Phase IIIb. Early Psoriatic Arthritis. Investigator initiated, double-blind, randomized, placebo-controlled, two-armed, parallel-group, single centre trial.

The Primary Objective is to assess whether the combination of golimumab with methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing clinical disease activity in patients with early, treatment naïve PsA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male and female patients aged ≥18 years at the time of signing the Informed Consent Form.

Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.

Subjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline.

Are treatment naïve to DMARDs. Are capable of understanding and signing an informed consent form. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy. Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent.

Patients fulfilling the following TB criteria:

7.1. Have no history of latent or active TB prior to screening. An exception is made for subjects with a history of latent TB and documentation of having completed appropriate treatment for latent TB 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.

7.2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.

7.3. Have had no close contact with a person with active TB or, if there has been such a contact, will be referred to a physician specializing in TB to undergo additional evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to or simultaneously with the first administration of study agent.

7.4. Within 6 weeks prior to the administration of study agent, either have a negative QuantiFERON-TB Gold test result or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.

7.5. In the event of 2 indeterminate QuantiFERON-TB Gold in-tube tests results, the subjects will be treated as if having latent TB prior or simultaneously with the first administration of study agent.

7.6. Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study.

7.7. Have a screening laboratory test result as follows: 7.7.1. Hb≥8.5 g/dL or ≥5.3 mmol/L 7.7.2. White blood cell (WBC) count ≥3.5x103 cells/uL 7.7.3. Neutrophils ≥1.5 x103 cells/uL 7.7.4. Platelets ≥100x103 cells/uL 7.7.5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (UKN) for the central laboratory conducting the test.

7.7.6. Serum creatinine not exceeding 1.5 mg/dL

Exclusion criteria

  • Received previous treatment with any DMARDs.
  • Received previous treatment with golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.
  • Any chronic inflammatory arthritis diagnosed before 16 years old. Exclusions for general safety

Patients with significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 52 weeks from screening, unstable angina pectoris, uncontrolled hypertension (BP>160/95), severe pulmonary disease, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, central nervous system (CNS) demyelinating events suggestive of multiple sclerosis, renal or gastrointestinal conditions, which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study or would make implementation of the protocol difficult.

Patients with cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within 5 years of screening.

Patients with current crystal or infective arthritis. Patients with chronic infection of the upper respiratory tract (eg. Sinusitis), chest (eg. Bronchiectatic lung disease), urinary tract or skin (eg. Paronychia, chronic ulcers, open wounds) within 4 weeks of screening.

Patients who have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB, histoplasmosis or coccidioidomycosis.

Patients with any ongoing or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within the preceding 30 days of screening and/or orally administered antibiotics in the preceding 15 days of screening.

Patients with abnormal liver function including known liver cirrhosis, fibrosis, or known alcoholic steatohepatitis (NASH) at the time of screening or abnormal blood tests as shown by:

Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x ULN, OR Bilirubin >51umol/L

Patients with known severe hypoproteinaemia at the time of screening, e.g. in nephrotic syndrome or impaired renal function, as shown by:

  • Serum Creatinine > 133 mol/L

Patients with known significantly impaired bone marrow function as for example significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by the following laboratory values at the time of screening:

White blood cells < 3000 x 106/L Platelets < 125 x 109/L Haemoglobin < 9.0 g/dL for males and < 8.5 g/dL for females Patients with a history of latent or active TB prior to screening will not be eligible. For exceptions refer to inclusion criteria.

Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for HBsAg (surface antigen), anti-HBs (surface antibody), and anti-HBc total (core antibody total).

11.1. Subjects who test positive for surface antigen (HBsAg+) are not eligible for this study, regardless of the results of other hepatitis B tests.

11.2. Subjects who test negative for surface antibody (HBsAg-) and test positive for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.

11.3. Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.

11.4. Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for hepatitis B deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is positive, the subject is not eligible for this study. If the HBV DNA test is negative, the subject is eligible for this study. In the event the DNA test cannot be performed, the subject is not eligible for the study.

Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.

Pregnancy, lactation (nursing) or women of child-bearing potential (WCBP) unwilling to use an effective birth control measure (Appendix 1) whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.

Men whose partners are of child-bearing potential but who are unwilling to use an effective birth control measure whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.

Patients who have received any corticosteroids within 4 weeks prior to screening.

Patients with a history of confirmed blood dyscrasia. Patients with a history of mental illness that would interfere with their ability to comply with the study protocol.

Patients with a history of drug and/or alcohol abuse that would interfere with their ability to comply with the study protocol.

Patients with a history of any viral hepatitis within 1 year of screening Patients who have received or are expected to receive any live virus or bacterial vaccinations or treatments that include live organisms (eg. a therapeutic infectious agent such as BCG that is instilled into the bladder for the treatment of cancer) within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of the study agent.

Patients who demonstrate Hypersensitivity to the active substance, or any of the excipients detailed in the SmPC.

Treatment and study plan

methotrexate

Drug

Methotrexate

Golimumab

Drug

Simponi

Primary outcomes

  1. Psoriatic Arthritis Disease Activity Score (PASDAS) at 24 Weeks

    Time frame: 24 weeks

    The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

Secondary outcomes

  1. Psoriatic Arthritis Disease Activity Score (PASDAS) at 12 Weeks.

    Time frame: 12 weeks

    The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

  2. Psoriatic Arthritis Disease Activity Score (PASDAS) at 36 Weeks.

    Time frame: 36 weeks

    The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

  3. Psoriatic Arthritis Disease Activity Score (PASDAS) at 52 Weeks.

    Time frame: 52 weeks

    The Psoriatic Arthritis Disease Activity Score ranges from 0-10; higher scores represent a worse outcome.

  4. Composite Psoriatic Disease Activity Index (CPDAI) at 12 Weeks.

    Time frame: 12 weeks

    The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

  5. Composite Psoriatic Disease Activity Index (CPDAI) at 24 Weeks.

    Time frame: 24 weeks

    The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

  6. Composite Psoriatic Disease Activity Index (CPDAI) at 36 Weeks.

    Time frame: 36 weeks

    The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

  7. Composite Psoriatic Disease Activity Index (CPDAI) at 52 Weeks.

    Time frame: 52 weeks

    The Composite Psoriatic Disease Activity Index ranges from 0-15; higher scores represent a worse outcome.

  8. Participant Disease Activity Visual Analogue Score at 24 Weeks.

    Time frame: 24 weeks

    The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.

  9. Participant Disease Activity Visual Analogue Score at 52 Weeks.

    Time frame: 52 weeks

    The Participant Disease Activity Visual Analogue Score ranges from 0-100; higher scores represent a worse outcome.

  10. 36-item Short Form Health Survey (SF-36) Physical Component Score at 24 Weeks.

    Time frame: 24 weeks

    The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.

  11. 36-item Short Form Health Survey (SF-36) Physical Component Score at 52 Weeks.

    Time frame: 52 weeks

    The 36-item Short Form Health Survey (SF-36) Physical Component Score ranges from 0-100; higher scores represent a better outcome.

  12. 36-item Short Form Health Survey (SF-36) Mental Component Score at 24 Weeks.

    Time frame: 24 weeks

    The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.

  13. 36-item Short Form Health Survey (SF-36) Mental Component Score at 52 Weeks.

    Time frame: 52 weeks

    The 36-item Short Form Health Survey (SF-36) Mental Component Score ranges from 0-100; higher scores represent a better outcome.

  14. Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 12 Weeks.

    Time frame: 12 weeks

    In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

  15. Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 24 Weeks.

    Time frame: 24 weeks

    In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

  16. Ultrasound Global OMERACT-EULAR System Score (GLOESS) at 36 Weeks.

    Time frame: 36 weeks

    In the joint set scanned in the Full Analysis Set, the Ultrasound Global OMERACT-EULAR System Score ranged from 0-72; higher scores represent a worse outcome.

  17. Ultrasound Entheseal Inflammatory Score at 12 Weeks.

    Time frame: 12 weeks

    The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

  18. Ultrasound Entheseal Inflammatory Score at 24 Weeks.

    Time frame: 24 weeks

    The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

  19. Ultrasound Entheseal Inflammatory Score at 36 Weeks.

    Time frame: 36 weeks

    The Ultrasound Entheseal Inflammatory Score ranged from 0-70; a higher score represents a worse outcome.

  20. Ultrasound Entheseal Chronicity Score at 12 Weeks.

    Time frame: 12 weeks

    The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

  21. Ultrasound Entheseal Chronicity Score at 24 Weeks.

    Time frame: 24 weeks

    The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

  22. Ultrasound Entheseal Chronicity Score at 36 Weeks.

    Time frame: 36 weeks

    The Ultrasound Entheseal Chronicity Score ranged from 0-50; a higher score represents a worse outcome.

  23. Leeds Enthesitis Index at 12 Weeks

    Time frame: 12 Weeks

    The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

  24. Leeds Enthesitis Index at 24 Weeks

    Time frame: 24 Weeks

    The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

  25. Leeds Enthesitis Index at 36 Weeks

    Time frame: 36 Weeks

    The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

  26. Leeds Enthesitis Index at 52 Weeks

    Time frame: 52 Weeks

    The Leeds Enthesitis Index ranges from 0-6; a higher score represents a worse outcome.

  27. Leeds Dactylitis Index at 12 Weeks

    Time frame: 12 Weeks

    The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

  28. Leeds Dactylitis Index at 24 Weeks

    Time frame: 24 Weeks

    The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

  29. Leeds Dactylitis Index at 36 Weeks

    Time frame: 36 Weeks

    The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

  30. Leeds Dactylitis Index at 52 Weeks

    Time frame: 52 Weeks

    The Leeds Dactylitis Index ranges from 0-~40; a higher score represents a worse outcome.

  31. The Modified Nail Psoriasis Severity Index (mNAPSI) at 12 Weeks

    Time frame: 12 Weeks

    The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

  32. The Modified Nail Psoriasis Severity Index (mNAPSI) at 24 Weeks

    Time frame: 24 Weeks

    The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

  33. The Modified Nail Psoriasis Severity Index (mNAPSI) at 36 Weeks

    Time frame: 36 Weeks

    The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

  34. The Modified Nail Psoriasis Severity Index (mNAPSI) at 52 Weeks

    Time frame: 52 Weeks

    The Modified Nail Psoriasis Severity Index ranges from 0-140; a higher score represents a worse outcome.

  35. Psoriasis Area and Severity Index (PASI) Score at 12 Weeks

    Time frame: 12 Weeks

    The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

  36. Psoriasis Area and Severity Index (PASI) Score at 24 Weeks

    Time frame: 24 Weeks

    The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

  37. Psoriasis Area and Severity Index (PASI) Score at 36 Weeks

    Time frame: 36 Weeks

    The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

  38. Psoriasis Area and Severity Index (PASI) Score at 52 Weeks

    Time frame: 52 Weeks

    The Psoriasis Area and Severity Index ranges from 0-72; a higher score represents a worse outcome.

  39. Dermatology Life Quality Index (DLQI) Score at 24 Weeks

    Time frame: 24 Weeks

    The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.

  40. Dermatology Life Quality Index (DLQI) Score at 52 Weeks

    Time frame: 52 Weeks

    The Dermatology Life Quality Index ranges from 0-30; a higher score represents a worse outcome.

  41. Minimal Disease Activity (MDA) at 12 Weeks

    Time frame: 12 Weeks

    Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

  42. Minimal Disease Activity (MDA) at 24 Weeks

    Time frame: 24 Weeks

    Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

  43. Minimal Disease Activity (MDA) at 36 Weeks

    Time frame: 36 Weeks

    Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

  44. Minimal Disease Activity (MDA) at 52 Weeks

    Time frame: 52 Weeks

    Minimal Disease Activity (coded 0=No, 1=Yes) is achieved when at least 5 of the 7 following criteria are met: Tender joint count (/68) ≤1 Swollen joint count (/66) ≤1 PASI ≤1 or BSA≤3 Patient pain VAS ≤15 Patient global disease activity VAS ≤20 HAQ ≤0.5 Enthesitis count ≤1.

  45. American College of Rheumatology 20 (ACR20) Response at 12 Weeks

    Time frame: 12 Weeks

    American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 20% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  46. American College of Rheumatology 20 (ACR20) Response at 24 Weeks

    Time frame: 24 Weeks

    American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 20% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  47. American College of Rheumatology 20 (ACR20) Response at 36 Weeks

    Time frame: 36 Weeks

    American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 20% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  48. American College of Rheumatology 20 (ACR20) Response at 52 Weeks

    Time frame: 52 Weeks

    American College of Rheumatology 20 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 20% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 20% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  49. American College of Rheumatology 50 (ACR50) Response at 12 Weeks

    Time frame: 12 Weeks

    American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 50% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  50. American College of Rheumatology 50 (ACR50) Response at 24 Weeks

    Time frame: 24 Weeks

    American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 50% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  51. American College of Rheumatology 50 (ACR50) Response at 36 Weeks

    Time frame: 36 Weeks

    American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 50% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  52. American College of Rheumatology 50 (ACR50) Response at 52 Weeks

    Time frame: 52 Weeks

    American College of Rheumatology 50 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 50% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 50% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  53. American College of Rheumatology 70 (ACR70) Response at 12 Weeks

    Time frame: 12 Weeks

    American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 70% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  54. American College of Rheumatology 70 (ACR70) Response at 24 Weeks

    Time frame: 24 Weeks

    American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 70% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  55. American College of Rheumatology 70 (ACR70) Response at 36 Weeks

    Time frame: 36 Weeks

    American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 70% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  56. American College of Rheumatology 70 (ACR70) Response at 52 Weeks

    Time frame: 52 Weeks

    American College of Rheumatology 70 Response (coded 0=No, 1=Yes) is achieved when there is:

    • 70% improvement in both TJC (68 joints count) and SJC (66 joints count) and
    • 70% improvement in at least 3 of the following 5 ACR Core set criteria:
    • Patient's Assessment of Pain Visual Analogue Scale (VAS)
    • Patient's Global Assessment of Disease Activity VAS
    • Physician's Global Assessment of Disease Activity VAS
    • Patient's Assessment of Physical Function as measured by the HAQ-DI
    • Acute phase reactant as measured by CRP

  57. Psoriatic Arthritis Response Criteria (PsARC) Response at 12 Weeks

    Time frame: 12 Weeks

    Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

    • At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)
    • At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)
    • At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)
    • At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

  58. Psoriatic Arthritis Response Criteria (PsARC) Response at 24 Weeks

    Time frame: 24 Weeks

    Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

    • At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)
    • At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)
    • At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)
    • At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

  59. Psoriatic Arthritis Response Criteria (PsARC) Response at 36 Weeks

    Time frame: 36 Weeks

    Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

    • At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)
    • At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)
    • At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)
    • At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

  60. Psoriatic Arthritis Response Criteria (PsARC) Response at 52 Weeks

    Time frame: 52 Weeks

    Psoriatic Arthritis Response Criteria Response (coded 0=No, 1=Yes) is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria:

    • At least 30% reduction in tender joint grade (total of 68 joints graded 0-3)
    • At least 30% reduction in swollen joint grade (total of 66 joints graded 0-3)
    • At least a 1 point reduction in physician's assessment of articular disease (1-5 Likert scale)
    • At least a 1 point reduction in patient's assessment of articular disease (1-5 Likert scale)

  61. Psoriatic Arthritis Skin Index (PASI) Response at 12 Weeks

    Time frame: 12 Weeks

    Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

  62. Psoriatic Arthritis Skin Index (PASI) Response at 24 Weeks

    Time frame: 24 Weeks

    Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

  63. Psoriatic Arthritis Skin Index (PASI) Response at 36 Weeks

    Time frame: 36 Weeks

    Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

  64. Psoriatic Arthritis Skin Index (PASI) Response at 52 Weeks

    Time frame: 52 Weeks

    Psoriatic Arthritis Skin Index (PASI) Response (coded 0=No, 1=Yes) is defined as an improvement of at least 75% in the PASI compared to baseline.

  65. Ultrasound Imaging Remission at 12 Weeks

    Time frame: 12 Weeks

    Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

  66. Ultrasound Imaging Remission at 24 Weeks

    Time frame: 24 Weeks

    Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

  67. Ultrasound Imaging Remission at 36 Weeks

    Time frame: 36 Weeks

    Ultrasound Imaging Remission (coded 0=No, 1=Yes) is achieved when all joints and entheses score grey scale<=1 & power Doppler=0.

  68. Additional Steroid Received Before 24 Weeks

    Time frame: 12 Weeks

    Participants were eligible for additional steroid at weeks 8 and 12 if they had not achieved a PsARC response; this variable was coded 0=No, 1=Yes.

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Collaborators

  • Janssen Pharmaceutica N.V., Belgium

Registry information

Official study title

An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.

Acronym: GOLMePsA

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 30, 2019
Registry last updated
Dec 2, 2025

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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