Status:
TERMINATED
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Juvenile Rheumatoid
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post ...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
- Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
- Onset of JIA must have occurred prior to the patient's 16th birthday.
- Patients must weigh at least 20 kg.
- Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day
Exclusion
- Patient currently with systemic features of systemic JIA.
- Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00637780
Start Date
June 1 2010
End Date
January 1 2014
Last Update
February 23 2017
Active Locations (2)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
2
Private Office
Guadalajara, Jalisco, Mexico, 44650