Summary
Abatacept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. ClinicalTrials.gov lists 8 registered trials linking Abatacept to Rheumatoid Arthritis: 2 are active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 338 participants (NCT04909801). Registration activity spans 2007 to 2021. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2025 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Rheumatoid Arthritis ranks 544 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 11% achieve drug-free remission (DFR) at median 74 months; most cohorts show 10-15% DFR ceiling.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 74.5 (trials 24.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 2 active / not yet recruiting, 3 completed, 3 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 systematic reviews) |
| Agent type | Biologic |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04251741 | Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment 2020 | status unknown | Phase 4 | 86 |
| NCT04909801 | A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate 2021 | active, not recruiting | Phase 3 | 338 |
| NCT00547521 | Phase IIIB Subcutaneous Abatacept Monotherapy Study 2007 | completed | Phase 3 | 119 |
| NCT01299961 | Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis 2011 | completed | Phase 3 | 25 |
| NCT03187444 | Cardiovascular Risk and Chronic Inflammatory Rheumatism 2015 | active, not recruiting | Not applicable | 200 |
| NCT02500498 | Safety Profile of Nulojix in Home Infusion Settings 2014 | completed | Not applicable | 37 |
| NCT03288584 | Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis 2017 | status unknown | Not applicable | 60 |
| NCT00947492 | Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs 2009 | status unknown | Not applicable | 60 |
Published literature
- Clinical trial publication Efficacy and safety of branebrutinib (BMS-986195), an irreversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2a, randomised, double-blind, placebo-controlled studyØstergaard M, Haavardsholm EA, Nowak M et al. · The Lancet. Rheumatology · 2026 · PMID 42081904
- Clinical trial publication Certolizumab pegol, abatacept, tocilizumab or active conventional therapy in early rheumatoid arthritis: 48-week patient-reported outcomes from the NORD-STAR trialLampa J, Nordström D, van Vollenhoven R et al. · The Lancet. Rheumatology · 2026 · PMID 41881637
- Clinical trial publication Safety and immunogenicity of the recombinant zoster vaccine in patients with rheumatoid arthritis using abatacept: a pilot multicentre, double-blind, randomised controlled trialHawkins JA, Curtis JR, Weinberg A et al. · Annals of the rheumatic diseases · 2026 · PMID 41672807
- Clinical trial publication Serum Proteomic Signatures of Rheumatoid Arthritis Risk and Response: Analysis of a Rheumatoid Arthritis Interception TrialJasenecova M, Coyle C, Mihalovits A et al. · Arthritis & rheumatology (Hoboken, N.J.) · 2026 · PMID 41657110
- Clinical trial publication Predictors of achieving clinical remission in ACPA-positive RA-patients treated with abatacept and methotrexate and methotrexate monotherapy: a post-hoc analysis of the AVERT and AVERT-II trialsBergstra SA, Verstappen M, Niemantsverdriet E et al. · Seminars in arthritis and rheumatism · 2026 · PMID 41544399
- Cochrane review Detectable safety gestalt of rheumatoid arthritis treatments from pivotal clinical drug trialsKonzett V, Kerschbaumer A, Willmann L et al. · Rheumatology (Oxford, England) · 2026 · PMID 42360790
- Cochrane review Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritisKonzett V, Laskou F, Smolen JS et al. · Annals of the rheumatic diseases · 2026 · PMID 41997804
- Cochrane review Effect of targeted therapies on pulmonary function in rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysisHilliquin S, Vismara E, Berlengiero V et al. · RMD open · 2026 · PMID 41856563
- Cochrane review Long-term persistence of biological agents in the treatment of patients with rheumatoid arthritis: a systematic literature review and meta-analysisSchneeberger EE, Felquer MLA, Citera G et al. · Clinical rheumatology · 2026 · PMID 41160371
- Cochrane review Mechanism and clinical utility of abatacept in the treatment of rheumatoid arthritisSu QY, Zhang JT, Gao HJ et al. · Expert opinion on drug safety · 2026 · PMID 40347194
- Systematic review Treatment of rheumatoid arthritis-associated interstitial lung disease: What is new since the 2022 SER-SEPAR recommendations?Narváez J, Díaz Del Campo Fontecha P, Nieto MA et al. · Reumatologia clinica · 2026 · PMID 41966849
- Systematic review From Methotrexate Resistance to Biologic and Targeted Pharmacotherapy: A Decade of Phase 4 Clinical Trials Evidence in Rheumatoid ArthritisAlsharif ST · Drug design, development and therapy · 2026 · PMID 41836530
- Meta-analysis Updated systematic literature review and meta-analysis to inform the Italian Society of Rheumatology Recommendations on the treatment of rheumatoid arthritis-associated interstitial lung diseaseFassio A, Sebastiani M, Pollastri F et al. · Autoimmunity reviews · 2025 · PMID 40876558
- Meta-analysis Abatacept and the risk of malignancy: a meta-analysis across disease indicationsZuckerman BP, Gibson M, Roy R et al. · Rheumatology (Oxford, England) · 2025 · PMID 39992258
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Abatacept approved for Rheumatoid Arthritis?
Abatacept has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Abatacept in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Abatacept to Rheumatoid Arthritis: 2 are active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 338 participants (NCT04909801). Registration activity spans 2007 to 2021.
What does the evidence show for Abatacept in Rheumatoid Arthritis?
Abatacept has both completed registered trials and synthesis-level publications linked to Rheumatoid Arthritis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.