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

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
University Hospitals Case Medical Center
Cleveland, Ohio, 44106 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00637780
Pfizer
Terminated
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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