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

January 3, 2017 updated by: Pfizer

An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Private office
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
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 Names:
  • AZULFIDINE EN-tabs Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
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
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
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
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
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 and 5-ASA are primary metabolites of sulfasalazine, the study drug.
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
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Screening through to and including 28 calendar days after the last administration of the investigational product
Number of Participants With Laboratory Test Abnormalities
Time Frame: 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).
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
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.
Screening, Day 0, and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0031005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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