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The "PASSPORT Trial": Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active Crohn's Disease or Ulcerative Colitis.
The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care. The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
Details
| Lead sponsor | CMC Ambroise Paré |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 130 |
| Start date | 2024-07-10 |
| Completion | 2025-01 |
Conditions
- Inflammatory Bowel Diseases
Interventions
- CT-P13
Primary outcomes
- Ratio SC/IV — Week 6
The ratio (SC/IV) of log-normal means of Ctrough at W6 and its 95% CI. Non inferiority will be considered as demonstrated if the lower limit of the 95%CI is higher than 80%.
Countries
France