Clinical trial NCT00637780: Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Sulfasalazine delayed release tablets
azulfidine entabs
Pharmacokinetics
Juvenile Idiopathic Arthritis (JIA)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: Sulfasalazine Time for Cmax (Tmax) at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: Sulfapyridine Steady State Cmax and Cmin
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: Sulfapyridine Tmax at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: Sulfapyridine AUCtau at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: 5-aminosalicylic Acid (5-ASA) Tmax at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
measure: 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
timeFrame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
timeFrame: Screening through to and including 28 calendar days after the last administration of the investigational product
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening, Day 0, and Day 7
measure: Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
timeFrame: Screening, Day 0, and Day 7
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Guadalajara
country: Mexico
facility: Private Office
state: Jalisco
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: