Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage

Rheumatoid Arthritis Clinical Trial

Official title: An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray

Status Completed

Clinical Trial Summary

The hypothesis of this study is that subcutaneous Abatacept is effective in reducing synovial inflammation, osteitis, and erosions in Rheumatoid Arthritis as assessed by low field extremity MRI and X-ray.

Clinical Trial Description

This is an open-label study of the efficacy of subcutaneous (SC) Abatacept to inhibit progression of structural joint damage in patients with active rheumatoid arthritis (RA) receiving MTX and have inadequate disease control (defined as an ESR based DAS28 ≥ 3.2 AND ≥ 6 swollen and ≥ 6 tender joints). The study consists of a screening period (Days -21 to -7), a baseline visit (Days -20 to -1), and a treatment Period (open label Abatacept 125 mg SC for 24 weeks). All the visits may occur at the indicated week +/- 2 days. The last efficacy assessments are to be conducted at Week 24 and subjects are to be contacted by telephone for a safety follow-up 2 months after the final study agent has been administered.

The maximum length of the study is 35 weeks, which includes the 2-week screening period, 1-week baseline period, 24-week open label treatment, and 8-week follow-up period. Eligible subjects are to continue their current MTX treatment regimen, a stable dose of at least 15mg/week, during the entire length of the study (24 weeks). At Day 0, patients who meet inclusion criteria, will be dosed from Day 0 to Week 24 with Abatacept 125 mg SC injection.

Subjects are to self-administer SC study agent at Weeks 5, 6, 7, 9, 10, 11, 13, 14, 15, 17, 18, 19, 21, 22, and 23 and are not required to return to the study site at these weeks. All other visits, SC study agent is to be administered while the subject is at the study site. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01333878
• Study type: Interventional
• Source: Orrin M Troum, M.D. and Medical Associates
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2011
• Completion date: January 2014