Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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 approval commitment to the FDA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sulfasalazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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