Summary
Celecoxib 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lists 8 registered trials linking Celecoxib to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00346216). It plans or enrolled 24081 participants. Registration activity spans 2002 to 2019. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2017 to 2025. 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 | 75.5 (trials 25.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02780323 | Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis 2015 | completed | Phase 4 | 119 |
| 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 |
| NCT00346216 | Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen 2006 | completed | Phase 4 | 24,081 |
| 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 |
| NCT00424294 | A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis 2006 | terminated | Phase 2 | 70 |
| NCT03912428 | Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions 2019 | terminated | Phase 1 | 31 |
| NCT00688545 | Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis 2009 | terminated | Not applicable | 275 |
Published literature
- Cochrane review Systematic review and meta-analysis of analgesic treatment options in patients with rheumatoid arthritis related painLautenschlager C, Stropes A, Smith A et al. · Advances in rheumatology (London, England) · 2025 · PMID 41108024
- Cochrane review Current Evidence on Celecoxib Safety in the Management of Chronic Musculoskeletal Conditions: An Umbrella ReviewBeaudart C, Brabant C, Alokail M et al. · Drugs · 2025 · PMID 40911151
- Clinical trial publication Evaluation of the efficacy and safety of a herbal formulation for rheumatoid arthritis - A non-inferiority randomized controlled trialAnsari UAMA, Uddin Q, Husain N et al. · Journal of ethnopharmacology · 2024 · PMID 38316221
- Clinical trial publication [Moxibustion combined with western medication for rheumatoid arthritis with blood stasis obstruction and its effect on platelet activation]Bai LK, Liang H, Wang WJ et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2023 · PMID 37577890
- Cochrane review Overview of Cochrane Systematic Reviews of rehabilitation interventions for persons with rheumatoid arthritis: a mapping synthesisKüçükdeveci AA, Turan BK, Arienti C et al. · European journal of physical and rehabilitation medicine · 2023 · PMID 36727299
- 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 Cardiovascular safety of celecoxib in rheumatoid arthritis and osteoarthritis patients: A systematic review and meta-analysisCheng BR, Chen JQ, Zhang XW et al. · PloS one · 2021 · PMID 34932581
- 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 Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trialKim HS, Choi WH, Kim BY et al. · The Journal of international medical research · 2020 · PMID 32589073
- Clinical trial publication PET measurement of cyclooxygenase-2 using a novel radioligand: upregulation in primate neuroinflammation and first-in-human studyShrestha S, Kim MJ, Eldridge M et al. · Journal of neuroinflammation · 2020 · PMID 32359360
- Randomized controlled trial 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
- Meta-analysis WITHDRAWN: Celecoxib for rheumatoid arthritisGarner SE, Fidan D, Frankish RR et al. · The Cochrane database of systematic reviews · 2017 · PMID 28598564
- Meta-analysis Celecoxib for rheumatoid arthritisFidahic M, Jelicic Kadic A, Radic M et al. · The Cochrane database of systematic reviews · 2017 · PMID 28597983
- Systematic 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
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 Celecoxib approved for Rheumatoid Arthritis?
Celecoxib 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 Celecoxib in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Celecoxib to Rheumatoid Arthritis: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00346216). It plans or enrolled 24081 participants. Registration activity spans 2002 to 2019.
What does the evidence show for Celecoxib in Rheumatoid Arthritis?
Celecoxib 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.