E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Juvenile Idiopathic Arthritis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the steady state pharmacokinetics of SSZ delayed release tablets in juvenile idiopathic arthritis patients. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of SSZ delayed release tablets in juvenile idiopathic arthritis patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
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 Tmax at Steady State
Sulfapyridine AUCtau at Steady State
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
5-aminosalicylic Acid (5-ASA) Tmax at Steady State
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
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E.5.2 | Secondary end point(s) |
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Number of Participants With Laboratory Test Abnormalities
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time Frame: Screening through to and including 28 calendar days after the last administration of the investigational product
Time Frame: Screening, Day 0, and Day 7
Time Frame: Screening, Day 0, and Day 7 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 10 |