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Completed

NCT Number: NCT01078155

Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

This post marketing observational study will be conducted in a prospective, single country, multicenter format to assess the prevention of generalized bone loss in patients with active rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing situations. The investigational sites will be centers with experience in the treatment of RA patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Immune System Diseases Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
  • Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
  • Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.

Exclusion criteria

  • Patients who have had a history of TNF blocking or rituximab therapy.
  • Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
  • Pregnant females and/or females without adequate method of contraception.
  • Patients who didn't receive prior DMARD therapy.
  • Patients participating in another study or clinical trial.
  • Patients with severe osteoporosis (T-score [number that indicates whether or not bone loss has occurred] of ≤ -2.5 and/or prior vertebral fracture/s).
  • Patients with a history of total hip replacement of both extremities.
  • Patients who currently receive and/or received bone metabolism modulating agents including Selective Estrogen Receptor Modulators (SERMs), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappaB ligand (RANKL) therapy.
  • Subjects who are not eligible for TNF-blocking therapy according to the Czech National Registry (ATTRA).

Treatment and study plan

Primary outcomes

  1. Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 12, Month 24

    BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.

  2. Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 12, Month 24

    T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.

  3. Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

  4. Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

  5. Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

  6. Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    Participant-reported the existence and duration of morning stiffness, defined as "morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."

  7. Tender Joint Count at Baseline, Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).

Secondary outcomes

  1. Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).

  2. Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.

  3. Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    Physician's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.

  4. Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    Subject's Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.

  5. Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    Subject's Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.

  6. Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24

    Time frame: Baseline (Day 0), Month 3, Month 12, Month 24

    ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 2, 2010
Registry last updated
Jun 26, 2015

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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