Phase 3
Completed N=220
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Source: ClinicalTrials.gov NCT02096861 ↗Enrolled (actual)
220
Serious AEs
8.6%
Results posted
Apr 2018
Primary outcomePrimary: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 — 77; 81 Participants
◆ Published Evidence
Highly cited
210citations · ~30 / year
Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study.
Summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Linked Publications (5)
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Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study.
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Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease.
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End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease.
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Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching.
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Clinical Decision Support Tool for Infliximab in Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 |
77; 81 | — |
| SECONDARY The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 |
85; 82 | — |
| SECONDARY The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 |
44; 39; 38; 42 | — |
| SECONDARY The Number and Percentage of Patients Achieving Clinical Remission at Week 6 |
47; 49 | — |
| SECONDARY The Number and Percentage of Patients Achieving Clinical Remission at Week 30 |
61; 62 | — |
| SECONDARY The Number and Percentage of Patients Achieving Clinical Remission at Week 54 |
35; 32; 29; 33 | — |
| SECONDARY The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |
34.3; 33.9; 46.4; 45.8; 51.1; 52.5 | — |
| SECONDARY The Short Inflammatory Bowel Disease Questionnaire |
34.7; 33.8; 33.3; 34.5; 54.4; 54.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
Exclusion Criteria
- Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
- Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
Data sourced from ClinicalTrials.gov (NCT02096861) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.