Clinical trial NCT01078155: Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Official title: Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Osteoporosis
Keywords: Bone mineral density
Bone turnover markers
Rheumatoid arthritis
Osteoporosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active rheumatoid arthritis

Brief 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.


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).

Primary outcomes:
measure: Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 12, Month 24
measure: Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 12, Month 24
measure: Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Tender Joint Count at Baseline, Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
Secondary outcomes:
measure: Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
measure: Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24
timeFrame: Baseline (Day 0), Month 3, Month 12, Month 24
Other outcomes:
Locations:
Study officials:
affiliation: Abbvie, Czech Republic & Slovakia
name: Maroš Lipták, MD
role: STUDY_DIRECTOR
References: