Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage
|Rheumatoid Arthritis||Biological: Subcutaneous Abatacept||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Inhibition & progression of structural damage [ Time Frame: 6 months ]Assess inhibition & progression of structural damage in MTX inadequate responders with moderate to severe active RA on SC Abatacept plus MTX, utilizing eMRI and X-ray at baseline, eMRI at Week 12, and eMRI and X-ray final assessment at week 24.
- Improvement in ESR-based DAS28 [ Time Frame: 6 months ]Assess improvement in ESR-based DAS28, physician global assessment, and improvement in HAQ score
|Study Start Date:||March 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Open-Label Subcutaneous Abatacept
Open-Label Subcutaneous Abatacept
Biological: Subcutaneous Abatacept
Subcutaneous Abatacept 125 mg once weekly for 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333878
|United States, California|
|Orrin M. Troum, MD and Medical Associates|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||Orrin M Troum, MD||Orrin M. Troum, MD & Medical Associates|