Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Sulfasalazine
  • Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days

Primary Measures

• Pharmacokinetic endpoints to include:sulfasalazine, sulfapyridine and 5-aminosalicylic acid: steady state (Day 7): Cmax ss, Tmax ss, AUCtau , Cmin ss, t1/2(data permitting)
  • Time Frame: Day 7
    Safety Issue?: No

Secondary Measures

• Safety endpoints to include adverse events, safety laboratory tests, and vital signs.
  • Time Frame: Day 1 through Day 9
    Safety Issue?: No

Inclusion Criteria:

• Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients with a history of systemic onset JIA whose disease has progressed to polyarthritis or oligoarthritis without current systemic features and who have been continuously treated with sulfasalazine (Azulfidine-EN) and have tolerated the product for at least 3 months prior to study enrolment 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 16 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 with a history of or currently in the active phase 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637780

Study ID Number: A0031005

ClinicalTrials.gov Identifier: NCT00637780

Health Authority: United States: Food and Drug Administration

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