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

Launched by ABBVIE (PRIOR SPONSOR, ABBOTT) · Feb 26, 2010

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Eligibility criteria

• 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).