Summary
Naproxen 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lists 8 registered trials linking Naproxen Sodium to Rheumatoid Arthritis: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status.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 5 publications for this pair: 5 clinical trial publications. Publication years run from 1981 to 1998. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 60.0 (trials 30.0, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 5 (5 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Naproxen concentrations in articular tissues after prolonged treatment with naproxen sodium in patients with arthritis of the hipBannwarth B, Lagrange F, Schaeverbeke T et al. · European journal of clinical pharmacology · 1998 · PMID 9923590
- Clinical trial publication Clinical efficacy and safety of Naprelan versus Naprosyn in the treatment of rheumatoid arthritisLisse JR · American journal of orthopedics (Belle Mead, N.J.) · 1996 · PMID 8886214
- Clinical trial publication [Clinical use of naproxen sodium in muscular skeletal disorders]Tang FS · Zhonghua wai ke za zhi [Chinese journal of surgery] · 1990 · PMID 2199170
- Clinical trial publication A double-blind, cross-over study of naproxen sodium and soluble aspirin in rheumatoid arthritisClarke AK, Macleod M, Steinberg VL et al. · The British journal of clinical practice · 1981 · PMID 7028063
- Clinical trial publication A single-dose analgesic study of naproxen sodium and soluble aspirin in patients with rheumatoid arthritisHuskisson EC, Engler C · Current medical research and opinion · 1981 · PMID 7021072
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 Sodium approved for Rheumatoid Arthritis?
Naproxen 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 Naproxen Sodium in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Naproxen Sodium 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 Sodium in Rheumatoid Arthritis?
Naproxen Sodium has 7 completed trials and 5 linked publications for Rheumatoid Arthritis. Completed trials may or may not have posted results; follow the NCT links to check. 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.