CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

Phase 3

Completed

Conditions: Crohn's Disease

Registration Number: NCT03945019

Lead Sponsor: Celltrion

Brief Summary: This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 396

Inclusion Criteria

Patient is male or female aged 18 to 75 years, inclusive.
Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Exclusion Criteria

Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54	Week 54	Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54	Week 54	Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving CDAI-100 Response at Week 54	Week 54	Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54	Week 54	Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of \>1. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54	Week 54	Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value. AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Trial Locations

Locations (29): Biopharma Informatic - Houston
🇺🇸
Houston, Texas, United States
Vitebsk Regional Clinical Hospital
🇧🇾
Vitebsk, Belarus
Diagnostic and Consulting Center Aleksandrovska EOOD
🇧🇬
Sofia, Bulgaria
Clinical Hospital Centre Osijek
🇭🇷
Osijek, Croatia
Fakultni nemocnice Ostrava
🇨🇿
Ostrava, Czechia
Centre Hospitalier Lyon Sud
🇫🇷
Pierre-Bénite, France
Praxis Prof. Herbert Kellner
🇩🇪
München, Germany
University General Hospital of Heraklion
🇬🇷
Heraklion, Greece
Debreceni Egyetem Klinikai Kozpont
🇭🇺
Debrecen, Hungary
Nirmal Hospital
🇮🇳
Surat, India
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Biopharma Informatic - Houston
🇺🇸Houston, Texas, United States