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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00637780
• Date of registration: 11/03/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
• Scientific title: An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
• Date of first enrolment: June 2010
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00637780
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, Mexico, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Juvenile Rheumatoid

Intervention(s)

Drug: Sulfasalazine

Primary Outcome(s)

5-aminosalicylic Acid (5-ASA) AUCtau at Steady State [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Sulfapyridine Steady State Cmax and Cmin [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

5-aminosalicylic Acid (5-ASA) Tmax at Steady State [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Sulfapyridine AUCtau at Steady State [Time Frame: 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 [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Sulfapyridine Tmax at Steady State [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Sulfasalazine Time for Cmax (Tmax) at Steady State [Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose]

Secondary Outcome(s)

Number of Participants With Laboratory Test Abnormalities [Time Frame: Screening, Day 0, and Day 7]

Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria [Time Frame: Screening, Day 0, and Day 7]

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs [Time Frame: Screening through to and including 28 calendar days after the last administration of the investigational product]

Secondary ID(s)

A0031005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00637780