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

NCT ID: NCT01078155

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-05-31

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maroš Lipták, MD

Role: STUDY_DIRECTOR

Abbvie, Czech Republic & Slovakia

Related Links

http://www.rxabbvie.com

Related Info

Other Identifiers

P10-733

Identifier Type: -

Identifier Source: org_study_id