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

AbbVie (prior sponsor, Abbott)131 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

131

Conditions

Rheumatoid Arthritis Osteoporosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

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

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.

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

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