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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00688545
First received: May 29, 2008
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
 Drug: Celecoxib
Drug: nsNSAIDs
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • General Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • disease activity, growth outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 275
Study Start Date: April 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Celecoxib
Patients treated with celecoxib as per treating physician's judgement
 Drug: Celecoxib
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
 Drug: nsNSAIDs
Non-interventional: Treatment assignment as per treating physician's judgement

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688545

  Show 27 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00688545     History of Changes
Other Study ID Numbers: A3191344
Study First Received: May 29, 2008
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Celecoxib
COX-2
NSAIDs
observational study
noninterventional study
cohort study
 registry
epidemiologic study
pediatrics
rheumatology
phase iv study

Additional relevant MeSH terms:
Arthritis, Juvenile Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013