Summary
Naproxen 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lists 8 registered trials linking Naproxen to Rheumatoid Arthritis: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00447759). It plans or enrolled 7297 participants. Registration activity spans 2000 to 2022. The literature layer holds 11 publications for this pair: 5 Cochrane reviews, 1 meta-analysis and 5 clinical trial publications. Publication years run from 2015 to 2022. 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: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 11 (5 Cochrane reviews, 5 clinical trial publications, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT00034853 | Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) 2000 | completed | Phase 3 | 180 |
| NCT00279747 | A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA) 2000 | completed | Phase 3 | 226 |
| NCT00652925 | A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA 2002 | completed | Phase 3 | 225 |
| NCT00527904 | A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO) 2007 | completed | Phase 3 | 239 |
| NCT00626275 | Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis 2007 | completed | Phase 2 | 46 |
| NCT00959439 | Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg) 2002 | completed | Phase 1 | 34 |
| NCT05504382 | Effect of Electroacupuncture on Refractory Pain in Juvenile Rheumatoid Arthritis: Randomized Controlled Trial 2022 | status unknown | Not applicable | 42 |
Published literature
- Clinical trial publication Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trialObeid S, Libby P, Husni E et al. · European heart journal. Cardiovascular pharmacotherapy · 2022 · PMID 35234840
- Cochrane review Use of corticoids and non-steroidal anti-inflammatories in the treatment of rheumatoid arthritis: Systematic review and network meta-analysisPaglia MDG, Silva MT, Lopes LC et al. · PloS one · 2021 · PMID 33826610
- Clinical trial publication Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled TrialSolomon DH, Shao M, Wolski K et al. · Arthritis & rheumatology (Hoboken, N.J.) · 2019 · PMID 30801994
- Clinical trial publication The potential benefits of aspirin for primary cardiovascular prevention in rheumatoid arthritis: a secondary analysis of the PRECISION TrialSolomon DH, Libby P, Yeomans ND et al. · Rheumatology (Oxford, England) · 2018 · PMID 29688503
- Clinical trial publication Randomised clinical trial: gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trialYeomans ND, Graham DY, Husni ME et al. · Alimentary pharmacology & therapeutics · 2018 · PMID 29667211
- Clinical trial publication Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical TrialSolomon DH, Husni ME, Wolski KE et al. · Arthritis & rheumatology (Hoboken, N.J.) · 2018 · PMID 29266879
- Cochrane review Gastrointestinal safety of etoricoxib in osteoarthritis and rheumatoid arthritis: A meta-analysisFeng X, Tian M, Zhang W et al. · PloS one · 2018 · PMID 29320568
- Cochrane review Non-steroidal anti-inflammatory drugs (NSAIDs) for chronic non-cancer pain in children and adolescentsEccleston C, Cooper TE, Fisher E et al. · The Cochrane database of systematic reviews · 2017 · PMID 28770976
- Cochrane review WITHDRAWN: Celecoxib for rheumatoid arthritisGarner SE, Fidan D, Frankish RR et al. · The Cochrane database of systematic reviews · 2017 · PMID 28598564
- Cochrane review Celecoxib for rheumatoid arthritisFidahic M, Jelicic Kadic A, Radic M et al. · The Cochrane database of systematic reviews · 2017 · PMID 28597983
- Meta-analysis Relative benefit-risk comparing diclofenac to other traditional non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors in patients with osteoarthritis or rheumatoid arthritis: a network meta-analysisvan Walsem A, Pandhi S, Nixon RM et al. · Arthritis research & therapy · 2015 · PMID 25879879
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 Naproxen approved for Rheumatoid Arthritis?
Naproxen 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 Naproxen in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Naproxen to Rheumatoid Arthritis: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00447759). It plans or enrolled 7297 participants. Registration activity spans 2000 to 2022.
What does the evidence show for Naproxen in Rheumatoid Arthritis?
Naproxen 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.