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

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Sulfasalazine

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid focused on measuring Sulfasalazine delayed release tablets, azulfidine entabs, Pharmacokinetics, Juvenile Idiopathic Arthritis (JIA)

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Case Medical Center
Private Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)

Sulfasalazine Time for Cmax (Tmax) at Steady State

Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State

Sulfapyridine Steady State Cmax and Cmin

Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.

Sulfapyridine Tmax at Steady State

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Sulfapyridine AUCtau at Steady State

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

5-aminosalicylic Acid (5-ASA) Tmax at Steady State

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

5-aminosalicylic Acid (5-ASA) AUCtau at Steady State

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

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

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).

Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

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.

Full Information

NCT ID

NCT00637780

First Posted

March 11, 2008

Last Updated

January 3, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00637780

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

Study terminated on 13 April 2016 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study

Study Start Date

June 2010 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Juvenile Rheumatoid

Keywords

Sulfasalazine delayed release tablets, azulfidine entabs, Pharmacokinetics, Juvenile Idiopathic Arthritis (JIA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sulfasalazine

Other Intervention Name(s)

AZULFIDINE EN-tabs Tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

Sulfasalazine Time for Cmax (Tmax) at Steady State

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

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

Title

Sulfapyridine Steady State Cmax and Cmin

Description

Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

Sulfapyridine Tmax at Steady State

Description

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

Sulfapyridine AUCtau at Steady State

Description

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin

Description

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

5-aminosalicylic Acid (5-ASA) Tmax at Steady State

Description

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Title

5-aminosalicylic Acid (5-ASA) AUCtau at Steady State

Description

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Time Frame

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Secondary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

Description

Time Frame

Screening through to and including 28 calendar days after the last administration of the investigational product

Title

Number of Participants With Laboratory Test Abnormalities

Description

Time Frame

Screening, Day 0, and Day 7

Title

Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

Description

Time Frame

Screening, Day 0, and Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Private Office

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0031005&StudyName=Study%20To%20Determine%20The%20Pharmacokinetics%20Of%20Sulfasalazine%20In%20Children%20With%20Juvenile%20Idiopathic%20Arthritis

Description

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

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