Summary
Etanercept 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trials linking Etanercept to Rheumatoid Arthritis: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 1821 participants (NCT01623752). Registration activity spans 2003 to 2021. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2024 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 | 74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 3 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04985435 | Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH) 2021 | recruiting | Phase 4 | 100 |
| NCT01793519 | Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis 2013 | status unknown | Phase 4 | 290 |
| NCT04251741 | Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment 2020 | status unknown | Phase 4 | 86 |
| NCT02357069 | A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy 2015 | status unknown | Phase 3 | 372 |
| NCT00245934 | Study Evaluating Enbrel in Patients With Rheumatoid Arthritis 2003 | completed | Not applicable | 1,500 |
| NCT01623752 | Prospective Evaluation of the Radiographic Efficacy of Enbrel 2012 | completed | Not applicable | 1,821 |
| 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 |
Published literature
- Clinical trial publication Response of ultrasound-assessed synovitis to baricitinib, in monotherapy and combined with methotrexate, compared with etanercept in rheumatoid arthritis: a randomised, international, multicentre trialNaredo E, Olivas-Vergara O, Borges PE et al. · Annals of the rheumatic diseases · 2026 · PMID 42025496
- 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
- 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
- Clinical trial publication Influence of anti-tumor necrosis factor (TNF) treatments on T cell cytokine production in patients with inflammatory joint diseases - comparison of etanercept and anti-TNF monoclonal antibodies. A double-blind, prospective, placebo-controlled studySchramm-Luc AI, Mikolajczyk TP, Siedlinski M et al. · Journal of physiology and pharmacology : an official journal of the Polish Physiological Society · 2025 · PMID 41364167
- 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 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 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 Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysisAndrade AM, da Motta Girardi J, da Silva ET et al. · Systematic reviews · 2024 · PMID 39605094
- 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
- Meta-analysis 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
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 Etanercept approved for Rheumatoid Arthritis?
Etanercept 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 Etanercept in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Etanercept to Rheumatoid Arthritis: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 1821 participants (NCT01623752). Registration activity spans 2003 to 2021.
What does the evidence show for Etanercept in Rheumatoid Arthritis?
Etanercept 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.