Phase 3 N=220 Randomized Double-blind Treatment

Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02096861 ↗

Enrolled (actual)

220

Serious AEs

8.6%

Results posted

Apr 2018

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CT-P13 (Biological); Remicade (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Celltrion
Primary completion: Jan 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02096861). 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.