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

NCT01078155 | Completed Results

• 1 other identifier: P10-733
• Study Type: observational
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Osteoporosis

Keywords

Bone mineral density; Bone turnover markers; Rheumatoid arthritis; Osteoporosis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (6)

• Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24

  Baseline (Day 0), Month 3, Month 12, Month 24

• Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24

  Baseline (Day 0), Month 3, Month 12, Month 24

• Visual Analogue Scale (VAS): Physician's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24

  Baseline (Day 0), Month 3, Month 12, Month 24

• Visual Analogue Scale (VAS): Subject's Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24

  Baseline (Day 0), Month 3, Month 12, Month 24

• Visual Analogue Scale (VAS): Subject's Assessment of Pain at Baseline, Month 3, Month 12, Month 24

  Baseline (Day 0), Month 3, Month 12, Month 24

Study Arms (1)

Participants with Active Rheumatoid Arthritis (RA)

Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant's enrollment in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active rheumatoid arthritis

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

osteocalcin (OC), C-terminal type I procollagen peptide (CICP), C-telopeptide of type I collagen (CTX-I), whole blood (serum)

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoporosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Maroš Lipták, MD

  Abbvie, Czech Republic & Slovakia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: March 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 26, 2015
• Results First Posted: May 29, 2015

Record last verified: 2015-05