Trial · NCT00688545
Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
NCT00688545, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis. Trials, record NCT00688545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00688545
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
- NCT number
- NCT00688545
- Status
- Terminated
- Enrollment
- 275 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Arthritis, Juvenile Rheumatoid
- Interventions
- Celecoxib, nsNSAIDs
- First posted
- 2008-06-03
- Last updated
- 2021-02-02
- Results first posted
- 2013-07-19
- Limitations and caveats
Study terminated prematurely: Sponsor released by FDA from post-marketing commitment. As a result, only a small number of participants/analyses could be performed, data must be interpreted with caution. Endpoints arbitrarily assigned as primary.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 2 years | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry. |
| Primary | JIA Concomitant Medications | Year 2 or early termination | JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 2 years | Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment. | Participants | NUMBER |
| PRIMARY | JIA Concomitant Medications | Year 2 or early termination | Safety Analysis Set subset of participants who received JIA concomitant medications | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Celecoxib | AEs | 36 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | nsNSAIDs | AEs | 117 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Celecoxib | SAEs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | nsNSAIDs | SAEs | 9 | Participants | |
| JIA Concomitant Medications | Celecoxib | GI protective agents | 20 | Participants | |
| JIA Concomitant Medications | nsNSAIDs | GI protective agents | 54 | Participants | |
| JIA Concomitant Medications | Celecoxib | Other GI | 5 | Participants | |
| JIA Concomitant Medications | nsNSAIDs | Other GI | 8 | Participants | |
| JIA Concomitant Medications | Celecoxib | DMARDs | 24 | Participants | |
| JIA Concomitant Medications | nsNSAIDs | DMARDs | 102 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 55 | |
| Overall Study | STARTED | nsNSAIDs | 219 | |
| Overall Study | Switched Treatment at Least Once | Celecoxib | 6 | |
| Overall Study | Switched Treatment at Least Once | nsNSAIDs | 13 | |
| Overall Study | COMPLETED | Celecoxib | 50 | |
| Overall Study | COMPLETED | nsNSAIDs | 204 | |
| Overall Study | NOT COMPLETED | Celecoxib | 5 | |
| Overall Study | NOT COMPLETED | nsNSAIDs | 15 |
Source ClinicalTrials.gov
Adverse events340
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Celecoxib | 1 | 68 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | nsNSAIDs | 1 | 225 | |
| other | Anaemia | Blood and lymphatic system disorders | Celecoxib | 0 | 68 | |
| other | Anaemia | Blood and lymphatic system disorders | nsNSAIDs | 1 | 225 | |
| other | Leukopenia | Blood and lymphatic system disorders | Celecoxib | 0 | 68 | |
| other | Leukopenia | Blood and lymphatic system disorders | nsNSAIDs | 1 | 225 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Celecoxib | 0 | 68 | |
| other | Lymphopenia | Blood and lymphatic system disorders | nsNSAIDs | 1 | 225 | |
| other | Tachycardia | Cardiac disorders | Celecoxib | 1 | 68 | |
| other | Tachycardia | Cardiac disorders | nsNSAIDs | 0 | 225 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | nsNSAIDs | ||
| Total, other adverse events | Celecoxib | 35 | 68 |
| Total, other adverse events | nsNSAIDs | 114 | 225 |
| Total, serious adverse events | Celecoxib | 2 | 68 |
| Total, serious adverse events | nsNSAIDs | 9 | 225 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25057265 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Celecoxib vs nsNSAIDs: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00688545
GET https://conductscience.org/api/trials/v1/NCT00688545/results?page=2