Summary
Infliximab 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lists 8 registered trials linking Infliximab to Rheumatoid Arthritis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 780 participants (NCT01692899). Registration activity spans 2005 to 2013. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2023 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 | 75.5 (trials 25.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 1 systematic review, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00714493 | RESTART C0168Z05 Rheumatoid Arthritis Study 2008 | completed | Phase 4 | 203 |
| NCT01793519 | Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis 2013 | status unknown | Phase 4 | 290 |
| NCT00202852 | A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED) 2005 | completed | Phase 3 | 143 |
| NCT01927263 | A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis 2013 | completed | Phase 3 | 242 |
| NCT00808210 | A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab 2009 | terminated | Phase 2 | 28 |
| NCT01692899 | Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice 2011 | completed | Not applicable | 780 |
| NCT01592292 | An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy 2011 | completed | Not applicable | 90 |
| NCT00440817 | An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohn's Disease. 2006 | completed | Not applicable | 120 |
Published literature
- Clinical trial publication A head-to-head comparison of TNF-α inhibitors as the first biologic treatment of rheumatoid arthritisKazemi AA, Kristianslund EK, Sexton J et al. · Rheumatology (Oxford, England) · 2026 · PMID 41533706
- Cochrane review Safety of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritisLaskou F, Konzett V, Smolen JS et al. · Annals of the rheumatic diseases · 2026 · PMID 41951459
- Meta-analysis IL17 genetic variants impact the response and safety of TNFi treatment in rheumatoid arthritis patients from Bahia, Brazilde Sá Garcia Landeiro L, Silva Dos Santos Rodrigues PA, de Oliveira AL et al. · Gene · 2026 · PMID 41274389
- Clinical trial publication Discontinuation versus continuation of maintenance treatment with tumor necrosis factor inhibitors in patients with rheumatoid arthritis with low disease activity or remission: A randomized double-blind placebo-controlled trialWard MM, Weinstein A, Alejandro-Silva P et al. · Seminars in arthritis and rheumatism · 2025 · PMID 41045868
- Clinical trial publication Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): An interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessmentsShimizu T, Kawashiri SY, Koga T et al. · Drug discoveries & therapeutics · 2025 · PMID 40850756
- Clinical trial publication Limited reduction of bone mineral density in patients with early rheumatoid arthritis receiving aggressive treatment: 10 year results of the NEO-RACo studySandström T, Kaipiainen-Seppänen O, Mali M et al. · Scandinavian journal of rheumatology · 2025 · PMID 40548492
- Cochrane review Hepatitis B reactivation linked to tumor necrosis factor-α inhibitors in rheumatoid arthritis: a systematic review and meta-analysisSalajegheh P, Yazdi F, Salajegheh A · Cellular and molecular biology (Noisy-le-Grand, France) · 2025 · PMID 41351367
- Meta-analysis Comparison of the Efficacy and Safety of Disease-Modifying Antirheumatic Drugs Combination Therapies: A Systematic Review and Network Meta-AnalysisLiu L, Ambe K, Onishi M et al. · Clinical and translational science · 2025 · PMID 40033744
- Systematic review Fungal Infections Associated With TNF-Inhibitors: A 20-Year of a Systematic Review Fungal Infections and TNF-InhibitorsBarbosa LSP, Ely MM, Salomé TM et al. · Mycoses · 2025 · PMID 40065425
- Cochrane review Merkel cell carcinoma associated with TNF inhibitor therapy: a systematic review of case reportsAlmashali M, Alotaibi MA, Shadid A · Dermatology online journal · 2024 · PMID 38959915
- Cochrane review Association between disease-modifying antirheumatic drugs for rheumatoid arthritis and risk of incident dementia: a systematic review with meta-analysisXie W, Hou Y, Xiao S et al. · RMD open · 2024 · PMID 38413170
- Meta-analysis The Association between Genetics and Response to Treatment with Biologics in Patients with Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, and Inflammatory Bowel Diseases: A Systematic Review and Meta-AnalysisAl-Sofi RF, Bergmann MS, Nielsen CH et al. · International journal of molecular sciences · 2024 · PMID 38891983
- Clinical trial publication Repair of joint damage in patients with rheumatoid arthritis does not relate to previous suppression of inflammation: a subanalysis after 8 years treat-to-target in the BeSt-trialvan der Pol JA, Akdemir G, van den Broek M et al. · RMD open · 2023 · PMID 37185308
- Cochrane review Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysisAscef BO, Almeida MO, Medeiros-Ribeiro AC et al. · JAMA network open · 2023 · PMID 37234004
- Randomized controlled trial Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trialConstantin A, Caporali R, Edwards CJ et al. · Rheumatology (Oxford, England) · 2023 · PMID 36534825
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 Infliximab approved for Rheumatoid Arthritis?
Infliximab 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 Infliximab in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Infliximab to Rheumatoid Arthritis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 780 participants (NCT01692899). Registration activity spans 2005 to 2013.
What does the evidence show for Infliximab in Rheumatoid Arthritis?
Infliximab 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.