Rheumatoid Arthritis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 | BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines. | Baseline (Day 0), Month 12, Month 24 | No |
Primary | Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and 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. | Baseline (Day 0), Month 12, Month 24 | No |
Primary | Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 | Baseline (Day 0), Month 3, Month 12, Month 24 | No | |
Primary | Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 | Baseline (Day 0), Month 3, Month 12, Month 24 | No | |
Primary | Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 | Baseline (Day 0), Month 3, Month 12, Month 24 | No | |
Primary | Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and 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." | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Primary | Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of tender joints at each study visit (28 joints are routinely examined). | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 | The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined). | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Disease Activity Score in 28 Joints (DAS28) at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
Secondary | Erythrocyte Sedimentation Rate (ESR) at Baseline, 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. | Baseline (Day 0), Month 3, Month 12, Month 24 | No |
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