Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
NCT00637780
ABOUT THIS 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
- 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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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis | |||
Official Title ICMJE | An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Arthritis, Juvenile Rheumatoid | |||
Intervention ICMJE | 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 Other Name: AZULFIDINE EN-tabs Tablets | |||
Study Arms ICMJE | Experimental: 1
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days Intervention: Drug: Sulfasalazine | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 2 | |||
Original Estimated Enrollment ICMJE | 12 | |||
Actual Study Completion Date ICMJE | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 6 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Mexico, United States | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00637780 | |||
Other Study ID Numbers ICMJE | A0031005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |