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



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:6 - 17
Updated:6/4/2016
Start Date:June 2010
End Date:January 2014

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An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis

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.


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
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Guadalajara, Jalisco 44650
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