Summary
Diclofenac Sodium 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lists 8 registered trials linking Diclofenac Sodium to Rheumatoid Arthritis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00447759). The largest enrolment is 23498 participants (NCT00250445). Registration activity spans 2003 to 2023. The literature layer holds 7 publications for this pair: 1 meta-analysis, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2005 to 2020. 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 | 66.5 (trials 29.5, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 7 (5 clinical trial publications, 1 meta-analysis, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00447759 | The Standard Care Versus Celecoxib Outcome Trial 2007 | completed | Phase 4 | 7,297 |
| NCT00141102 | Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis 2005 | completed | Phase 4 | 4,484 |
| NCT01067430 | Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA) 2010 | withdrawn | Phase 4 | — |
| NCT00092742 | Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072) 2003 | completed | Phase 3 | 4,086 |
| NCT00250445 | A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066) 2003 | completed | Phase 3 | 23,498 |
| NCT06594822 | Effectiveness of Probiotics in Patients of Mild to Moderate Rheumatoid Arthritis 2023 | completed | Phase 3 | 88 |
| NCT00264147 | Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED) 2006 | completed | Phase 2 | 761 |
| NCT01579890 | Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis | approved_for_marketing | Not applicable | — |
Published literature
- Clinical trial publication Formulation of Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents for the Treatment of Rheumatoid ArthritisJurca T, Józsa L, Suciu R et al. · Molecules (Basel, Switzerland) · 2020 · PMID 33374575
- Clinical trial publication [Long-snake moxibustion for rheumatoid arthritis:a randomized controlled trial]Zhang W, Chen M, Hu J · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2016 · PMID 29231407
- Clinical trial publication [Clinical efficacy of moxibustion as supplement on rheumatoid arthritis and the exploration on its mechanism]Hongwu Y, Yan Z, Yuzhen P et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2016 · PMID 26946727
- Clinical trial publication A randomized, pilot study to assess the efficacy and safety of curcumin in patients with active rheumatoid arthritisChandran B, Goel A · Phytotherapy research : PTR · 2012 · PMID 22407780
- Clinical trial publication [Dynamics of intragastric acidity in patients with osteoarthritis and rheumatoid arthritis during therapy with diclofenac sodium]Abdulganieva DI, Belianskaia NE · Eksperimental'naia i klinicheskaia gastroenterologiia = Experimental & clinical gastroenterology · 2011 · PMID 21916232
- Randomized controlled trial [Observation on therapeutic effect of muscular needling combined with scarring moxibustion on active stage of rheumatoid arthritis]Chen XH, Yao WM, Zou CP et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2009 · PMID 19994686
- Meta-analysis Meta-analysis: upper gastrointestinal tolerability of valdecoxib, a cyclooxygenase-2-specific inhibitor, compared with nonspecific nonsteroidal anti-inflammatory drugs among patients with osteoarthritis and rheumatoid arthritisEisen GM, Goldstein JL, Hanna DB et al. · Alimentary pharmacology & therapeutics · 2005 · PMID 15740543
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 Diclofenac Sodium approved for Rheumatoid Arthritis?
Diclofenac Sodium 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 Diclofenac Sodium in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Diclofenac Sodium to Rheumatoid Arthritis: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00447759). The largest enrolment is 23498 participants (NCT00250445). Registration activity spans 2003 to 2023.
What does the evidence show for Diclofenac Sodium in Rheumatoid Arthritis?
Diclofenac Sodium 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.