Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
NCT00688545
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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).
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Phoenix, Arizona
- Little Rock, Arkansas
- Washington, District of Columbia
- Arlington Heights, Illinois
- Chigcago, Illinois
- Glenview, Illinois
- New Lenox, Illinois
- Westchester, Illinois
- Omaha, Nebraska
- Hackensack, New Jersey
- Livingston, New Jersey
- Brooklyn, New York
- Brooklyn, New York
- Commack, New York
- Great Neck, New York
- New Hyde Park, New York
- NYC, New York
- Durham, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Liberty Township, Ohio
- Mayfield Heights, Ohio
- Strongsville, Ohio
- Philadelhia, Pennsylvania
- Charleston, South Carolina
- Nashville, Tennessee
- Austin, Texas
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis | |||
Official Title | SINCERE?: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs | |||
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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Juvenile Idiopathic Arthritis (JIA) subtypes that correspond to the former Juvenile Rheumatoid Arthritis (JRA) classification system who are treated by a participating pediatric rheumatologist and treated with either celecoxib or an nsNSAID; celecoxib or nsNSAID must be new treatment or recent initiation (within last 6 months). | |||
Condition | Arthritis, Juvenile Rheumatoid | |||
Intervention |
| |||
Study Groups/Cohorts |
| |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 275 | |||
Original Estimated Enrollment | 400 | |||
Actual Study Completion Date | January 2012 | |||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 2 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00688545 | |||
Other Study ID Numbers | A3191344 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2013 |