Clinical trial · Interventional
Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abatacept | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Abatacept
- description
- Short Term Portion of Study
- interventionNames
- Drug: Abatacept
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Short Term Portion of Study
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Abatacept (Long Term)
- description
- Long Term Portion of Study: All participants receive Active Drug
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Eligibility Criteria: * Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past. Exclusion Criteria: * Women who are pregnant or breast feeding * Current symptoms of serious medical disease * History of cancer in last 5 years other than non-melanoma skin cancer * Chronic serious infection * Active TB requiring treatment in last 5 years * Herpes zoster in last 2 months * Any active viral infection including Human Immunodeficiency Virus (HIV) * Serious side effects associated with previous anti-TNF therapy
References
Publications (4)
- BACKGROUNDHassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908x297376. Epub 2008 Apr 9. PMID 18402714
- BACKGROUNDStewart AL and Ware JE. Measuring function and well being. The Medical Outcomes Study Approach. Durham, NC: Duke University Press. 1992.
- BACKGROUNDSpritzer KL, Hays RD. (2003, November). MOS Sleep Scale: A Manual For Use and Scoring, Version 1.0. Los Angeles, CA.
- DERIVEDAlten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5. PMID 29329602