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

Arthritis, Juvenile Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637780
• Other study ID #: A0031005
• Status: Terminated
• Phase: Phase 4
• First received: March 11, 2008
• Last updated: July 18, 2016
• Start date: June 2010
• Est. completion date: January 2014

Study information

• Verified date: July 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid

Intervention

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

Locations

Country	Name	City	State
Mexico	Private Office	Guadalajara	Jalisco
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Day 7	No
Secondary	Safety endpoints to include adverse events, safety laboratory tests, and vital signs.		Day 1 through Day 9	No

External Links

•   To obtain contact information for a study center near you, click here.