Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis

Terminated

• Conditions: Arthritis, Juvenile Rheumatoid
• Interventions: Drug: Celecoxib; Drug: nsNSAIDs

• Registration Number: NCT00688545
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This multi-center observational Registry will collect long-term safety data on patients treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).

Detailed Description

None Study has been terminated early (LSLV = 09Jan2012) due to release of the postmarketing commitment by the US FDA. The study was stopped for futility/change in treatment paradigm that minimizes chronic NSAID use and not for safety concerns.

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-03
• Study Start: 2009-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-05-07
• Results First Submitted QC: 2013-05-07
• Results First Posted: 2013-07-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
• new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).

Exclusion Criteria

• Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
• Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
• Patients who need to use multiple NSAIDs at the same time.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	Patients treated with celecoxib as per treating physician's judgement
nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)	nsNSAIDs	Patients treated with nsNSAIDs as per treating physician's judgement

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Austin, Texas, United States