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

Phase 4

Terminated

• Conditions: Arthritis, Juvenile Rheumatoid
• Interventions: Drug: Sulfasalazine

• Registration Number: NCT00637780
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Study Start: 2010-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2016-09-20
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sulfasalazine	Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days

Primary Outcome Measures

Name	Time	Method
Sulfasalazine Time for Cmax (Tmax) at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine Tmax at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Tmax at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine AUCtau at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Sulfapyridine Steady State Cmax and Cmin	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State	Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose	Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria	Screening, Day 0, and Day 7	Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (\<) 40 or more than (\>) 120 beats per minute (bpm); erect pulse rate \<40 or \>140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (\>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) \>=20 mm Hg; SBP \<90 mm Hg; and DBP \<50 mm Hg.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs	Screening through to and including 28 calendar days after the last administration of the investigational product	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Laboratory Test Abnormalities	Screening, Day 0, and Day 7	Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).

Trial Locations

Locations (2)

Private Office; 🇲🇽 Guadalajara, Jalisco, Mexico

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States