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

NCT00637780 | Terminated Phase 4 Results

• 1 other identifier: A0031005
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

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.

Conditions

Arthritis, Juvenile Rheumatoid

Keywords

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

Outcome Measures

Primary Outcomes (9)

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

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

• 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 Steady State Cmax and Cmin

  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

  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

  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

  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

  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

  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 Outcomes (3)

• 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

• Number of Participants With Laboratory Test Abnormalities

  Screening, Day 0, and Day 7

• Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

  Screening, Day 0, and Day 7

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Sulfasalazine

Interventions

Sulfasalazine DRUG

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

Also known as: AZULFIDINE EN-tabs Tablets

1

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Private Office

Guadalajara, Jalisco, 44650, Mexico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Sulfasalazine; Sulfadiazine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Benzenesulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

The study was terminated prematurely and only 2 participants were enrolled and completed the study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: June 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Locations

ME (1); US (1)