Summary
Adalimumab 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 Adalimumab to Rheumatoid Arthritis: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 780 participants (NCT01692899). Registration activity spans 2008 to 2021. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 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 | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| 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 |
| NCT01185301 | Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA) 2010 | completed | Phase 3 | 395 |
| NCT00690573 | Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis 2008 | completed | Phase 3 | 25 |
| NCT02019472 | A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis 2014 | completed | Phase 3 | 559 |
| 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 Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE studyFleischmann R, Swierkot J, Durez P et al. · RMD open · 2026 · PMID 42342288
- Clinical trial publication Upadacitinib vs adalimumab in patients with rheumatoid arthritis and a prior inadequate response or intolerance to a tumour necrosis factor inhibitor: 12-week results from the randomised, double-blind, SELECT-SWITCH studyMysler E, Sidiropoulos PI, Balanescu A et al. · Annals of the rheumatic diseases · 2026 · PMID 41991443
- 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
- Clinical trial publication Effects of upadacitinib or adalimumab on pain in rheumatoid arthritis and psoriatic arthritis: results from randomised phase 3 studiesTaylor PC, Kavanaugh A, Bessette L et al. · RMD open · 2026 · PMID 41506743
- 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
- Clinical trial publication Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trialsStrand V, Schulze-Koops H, Al-Emadi S et al. · BMJ open · 2025 · PMID 41448717
- 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
- Cochrane review Comparison of the efficacy of Janus kinase inhibitors and adalimumab in rheumatoid arthritis: a meta-analysisZhou Q, Zhu S, Dai S et al. · Clinical and experimental rheumatology · 2025 · PMID 39977004
- Meta-analysis Efficacy and safety of upadacitinib for patients with immune-mediated inflammatory diseases: a systematic review and meta-analysisChai R, Li X, Shen W et al. · Frontiers in immunology · 2025 · PMID 40666511
- 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 Approaches and outcomes of adalimumab discontinuation in patients with well-controlled inflammatory arthritis: a systematic search and reviewBalay-Dustrude E, Fennell J, Baszis K et al. · Pediatric rheumatology online journal · 2024 · PMID 39734203
- 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 Efficacy and safety of current therapies for difficult-to-treat rheumatoid arthritis: a systematic review and network meta-analysisSu QY, Luo J, Zhang Y et al. · Journal of translational medicine · 2024 · PMID 39198829
- Meta-analysis The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysisQu B, Zhao F, Song Y et al. · PloS one · 2024 · PMID 38905267
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 Adalimumab approved for Rheumatoid Arthritis?
Adalimumab 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 Adalimumab in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Adalimumab to Rheumatoid Arthritis: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01793519). The largest enrolment is 780 participants (NCT01692899). Registration activity spans 2008 to 2021.
What does the evidence show for Adalimumab in Rheumatoid Arthritis?
Adalimumab 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.