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

NCT ID: NCT00688545

Last Updated: 2021-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Arthritis, Juvenile Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Celecoxib

Patients treated with celecoxib as per treating physician's judgement

Celecoxib

Intervention Type DRUG

Non-interventional: Treatment assignment as per treating physician's judgement

nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)

Patients treated with nsNSAIDs as per treating physician's judgement

nsNSAIDs

Intervention Type DRUG

Non-interventional: Treatment assignment as per treating physician's judgement

Interventions

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Celecoxib

Non-interventional: Treatment assignment as per treating physician's judgement

Intervention Type DRUG

nsNSAIDs

Non-interventional: Treatment assignment as per treating physician's judgement

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

Washington D.C., District of Columbia, United States

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Pfizer Investigational Site

Arlington Heights, Illinois, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Pfizer Investigational Site

Glenview, Illinois, United States

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Pfizer Investigational Site

New Lenox, Illinois, United States

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Pfizer Investigational Site

Westchester, Illinois, United States

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Pfizer Investigational Site

Omaha, Nebraska, United States

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Pfizer Investigational Site

Hackensack, New Jersey, United States

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Livingston, New Jersey, United States

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Pfizer Investigational Site

Brooklyn, New York, United States

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Pfizer Investigational Site

Brooklyn, New York, United States

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Pfizer Investigational Site

Commack, New York, United States

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Pfizer Investigational Site

Great Neck, New York, United States

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Pfizer Investigational Site

New Hyde Park, New York, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

Durham, North Carolina, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Cleveland, Ohio, United States

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Pfizer Investigational Site

Liberty Township, Ohio, United States

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Pfizer Investigational Site

Mayfield Heights, Ohio, United States

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Pfizer Investigational Site

Strongsville, Ohio, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pfizer Investigational Site

Charleston, South Carolina, United States

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Pfizer Investigational Site

Nashville, Tennessee, United States

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Pfizer Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

References

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Sobel RE, Lovell DJ, Brunner HI, Weiss JE, Morris PW, Gottlieb BS, Chalom EC, Jung LK, Onel KB, Petiniot L, Goldsmith DP, Nanda K, Shishov M, Abramsky S, Young JP, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry. Pediatr Rheumatol Online J. 2014 Jul 16;12:29. doi: 10.1186/1546-0096-12-29. eCollection 2014.

Reference Type DERIVED
PMID: 25057265 (View on PubMed)

Related Links

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Other Identifiers

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A3191344

Identifier Type: -

Identifier Source: org_study_id

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