18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).Primary· Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months
APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).
ITT (N = 8072, 8040, 7969)
Group
Value
95% CI
Celecoxib
2.3
Ibuprofen
2.7
Naproxen
2.5
MITT (N = 8030, 7990, 7933)
Group
Value
95% CI
Celecoxib
1.7
Ibuprofen
1.9
Naproxen
1.8
The First Occurrence of a Major Adverse Cardiovascular Events (MACE)Secondary· ITT Population - 30 months; MITT Population - 42 months
MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA
ITT (N = 8072, 8040, 7969)
Group
Value
95% CI
Celecoxib
4.2
Ibuprofen
4.8
Naproxen
4.3
MITT (N = 8030, 7990, 7933)
Group
Value
95% CI
Celecoxib
3.1
Ibuprofen
3.6
Naproxen
3.2
The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)Secondary· ITT Population - 30 months; MITT Population - 42 months
CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer
ITT (N = 8072, 8040, 7969)
Group
Value
95% CI
Celecoxib
0.7
Ibuprofen
0.9
Naproxen
0.7
MITT (N = 8030, 7990, 7933)
Group
Value
95% CI
Celecoxib
0.3
Ibuprofen
0.7
Naproxen
0.7
Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)Secondary· ITT and MITT Population - Baseline to 42 months
VAS question "How much pain do you have" was graded on a scale from 0 to 100 with 0 indicating "No pain" and 100 indicating "Worst possible pain".
Baseline (ITT) N= 8014, 8001, 7928
Group
Value
95% CI
Celecoxib
54.0
± 23.53
Ibuprofen
54.1
± 23.58
Naproxen
54.1
± 24.04
Change-Baseline to Mon1 (ITT) N=7382, 7379, 7325
Group
Value
95% CI
Celecoxib
-8.2
± 24.69
Ibuprofen
-9.0
± 25.69
Naproxen
-9.9
± 25.53
Change-Baseline to Mon2 (ITT) N=7180, 7090, 7149
Group
Value
95% CI
Celecoxib
-10.5
± 26.39
Ibuprofen
-10.6
± 26.92
Naproxen
-11.1
± 26.83
Change-Baseline to Mon4 (ITT) N=6777, 6696, 6740
Group
Value
95% CI
Celecoxib
-11.4
± 27.70
Ibuprofen
-11.7
± 28.10
Naproxen
-12.3
± 27.80
Change-Baseline to Mon8 (ITT) N=6230, 6137, 6159
Group
Value
95% CI
Celecoxib
-11.7
± 28.92
Ibuprofen
-12.1
± 28.97
Naproxen
-12.1
± 28.83
Change-Baseline to Mon12 (ITT) N=5792, 5696, 5846
Group
Value
95% CI
Celecoxib
-11.0
± 29.15
Ibuprofen
-11.6
± 29.29
Naproxen
-11.9
± 29.30
Change-Baseline to Mon18 (ITT) N=5310, 5181. 5246
Group
Value
95% CI
Celecoxib
-11.3
± 29.11
Ibuprofen
-11.3
± 29.10
Naproxen
-11.7
± 29.33
Change-Baseline to Mon24 (ITT) N=4818, 4776, 4785
Group
Value
95% CI
Celecoxib
-11.3
± 29.44
Ibuprofen
-11.5
± 28.98
Naproxen
-11.4
± 29.27
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from the signing of the informed consent throughout the entire study period (42 months) and including 30 calendar days after the last administration of the investigational product..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05281276 — Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)
· Phase 1
· terminated
NCT05324995 — Peri-Articular-Multimodal Drug and Oral Celecoxib in Management of Postoperative Pain of Total Knee Arthroplasty
· Phase 2
· completed
NCT02876094 — Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy
· Phase 2
· terminated
NCT02079727 — Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA
· Phase 3
· completed
NCT01705106 — Capecitabine and Celecoxib in Patients With Solid Cancers That Have Been Previously Treated With Standard Therapies
· Phase 1
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last refreshed: 3 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00346216.