N/A
Completed N=131
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01078155 ↗Enrolled (actual)
131
Serious AEs
0.8%
Results posted
May 2015
Primary outcomePrimary: Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 — 1.06; 1.07; 1.06; 0.88 g/cm^2
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24 |
1.06; 1.07; 1.06; 0.88; 0.91; 0.90 | — |
| PRIMARY Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24 |
-0.57; -0.42; -0.40; -0.02; 0.15; 0.21 | — |
| PRIMARY Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24 |
-2.97; -2.21; 1.39 | — |
| PRIMARY Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24 |
8.70; -1.87; 15.29 | — |
| PRIMARY Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24 |
-0.01; 0.06; -0.01 | — |
| PRIMARY Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24 |
95.0; 37.5; 27.7; 25.8 | — |
| PRIMARY Tender Joint Count at Baseline, Month 3, Month 12, and Month 24 |
14.3; 3.1; 1.9; 1.7 | — |
| SECONDARY Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24 |
9.5; 2.3; 1.0; 1.0 | — |
| SECONDARY Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24 |
6.24; 3.55; 2.86; 2.83 | — |
| SECONDARY Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 |
68.0; 29.7; 23.0; 21.5 | — |
| SECONDARY Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24 |
71.1; 31.4; 24.7; 24.0 | — |
| SECONDARY Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24 |
71.3; 29.4; 25.8; 24.2 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24 |
37.77; 17.97; 17.15; 17.67 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01078155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.