Summary
Rituximab 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linking Rituximab to Rheumatoid Arthritis: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 378 participants (NCT00422383). Registration activity spans 2006 to 2024. 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 | 71.0 (trials 21.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 4 completed, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04251741 | Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment 2020 | status unknown | Phase 4 | 86 |
| NCT00422383 | A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) 2006 | completed | Phase 3 | 378 |
| NCT00664521 | Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) 2008 | completed | Phase 2 | 27 |
| NCT03061838 | Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® 2016 | terminated | Phase 1 | 8 |
| NCT06475495 | Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis 2024 | active, not recruiting | PHASE1, PHASE2 | 13 |
| NCT05487703 | A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting 2022 | completed | Not applicable | 318 |
| 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 |
| NCT03288584 | Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis 2017 | status unknown | Not applicable | 60 |
Published literature
- Clinical trial publication Transcriptomic stratification predicts response to rituximab, abatacept, or the association of hydroxychloroquine and leflunomide in 3 randomised controlled clinical trials of Sjögren's diseaseChevet B, Devauchelle-Pensec V, Pontarini E et al. · Annals of the rheumatic diseases · 2026 · PMID 41448992
- 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 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
- Meta-analysis Effects of biologic and targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs) on patient-reported outcome domains in rheumatoid arthritis: a systematic review and network meta-analysesvan Esveld L, Dikkenberg MVD, Luurssen-Masurel N et al. · RMD open · 2026 · PMID 42342282
- 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
- Clinical trial publication Deep molecular profiling of synovial biopsies in the STRAP trial identifies signatures predictive of treatment response to biologic therapies in rheumatoid arthritisLewis MJ, Çubuk C, Surace AEA et al. · Nature communications · 2025 · PMID 40603860
- Cochrane review Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren's syndromeZheng X, Di J, Chen X et al. · Frontiers in immunology · 2025 · PMID 40630946
- Meta-analysis Efficacy and safety of rituximab in rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysisInes M, Zeineb Z, Selma B et al. · Expert opinion on biological therapy · 2025 · PMID 41004196
- 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
- Clinical trial publication Comparing immunogenicity and safety following transition from reference rituximab to biosimilar rituximab (DRL_RI) in patients with rheumatoid arthritis: a randomized, double-blind, phase 3 studyMaharaj N, Uppada DR, Reddy N et al. · Arthritis research & therapy · 2024 · PMID 39709462
- Clinical trial publication The effect of rituximab on patient reported outcomes in the preclinical phase of rheumatoid arthritis: 2 year data from the PRAIRI studyFrazzei G, Cramer SHM, Landewé RBM et al. · RMD open · 2024 · PMID 39424405
- Clinical trial publication Results of a 12-Week Open-Label, Non-Interventional Study of the Efficacy and Safety of Olokizumab Therapy in Patients with Rheumatoid Arthritis after Switching from Anti-B-Cell Therapy during the SARS-CoV-2 PandemicAkimova AA, Banshchikova NE, Sizikov AE et al. · Doklady. Biochemistry and biophysics · 2024 · PMID 38955912
- Cochrane review Efficacy of non-conventional synthetic DMARDs for patients with rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysisYuan H, Cui S, Yang L et al. · RMD open · 2023 · PMID 37899093
- Cochrane review Effect of body mass index on treatment response of biologic/targeted-synthetic DMARDs in patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis. A systematic reviewGialouri CG, Pappa M, Evangelatos G et al. · Autoimmunity reviews · 2023 · PMID 37150489
- Randomized controlled trial Stratification of biological therapies by pathobiology in biologic-naive patients with rheumatoid arthritis (STRAP and STRAP-EU): two parallel, open-label, biopsy-driven, randomised trialsRivellese F, Nerviani A, Giorli G et al. · The Lancet. Rheumatology · 2023 · PMID 38251532
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 Rituximab approved for Rheumatoid Arthritis?
Rituximab 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 Rituximab in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Rituximab to Rheumatoid Arthritis: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04251741). The largest enrolment is 378 participants (NCT00422383). Registration activity spans 2006 to 2024.
What does the evidence show for Rituximab in Rheumatoid Arthritis?
Rituximab 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.