Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
This study has suspended participant recruitment.
Information provided by (Responsible Party):
First received: March 11, 2008
Last updated: March 13, 2015
Last verified: March 2015
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.
Arthritis, Juvenile Rheumatoid
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
Primary Outcome Measures:
- Pharmacokinetic endpoints to include:sulfasalazine, sulfapyridine and 5-aminosalicylic acid: steady state (Day 7): Cmax ss, Tmax ss, AUCtau , Cmin ss, t1/2(data permitting) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety endpoints to include adverse events, safety laboratory tests, and vital signs. [ Time Frame: Day 1 through Day 9 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2024 (Final data collection date for primary outcome measure)
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
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 Name: AZULFIDINE EN-tabs Tablets
|Ages Eligible for Study:
||6 Years to 17 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637780
|University Hospitals Case Medical Center
|Cleveland, Ohio, United States, 44106 |
|Guadalajara, Jalisco, Mexico, 44650 |
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 11, 2008
||March 13, 2015
||United States: Food and Drug Administration
Keywords provided by Pfizer:
Sulfasalazine delayed release tablets
Juvenile Idiopathic Arthritis (JIA)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Connective Tissue Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents