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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
396
Subcutaneous injection of CT-P13 SC
Subcutaneous injection of Placebo SC
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at 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.
Time frame: Week 54
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at 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.
Time frame: Week 54
Percentage of Patients Achieving CDAI-100 Response at 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.
Time frame: Week 54
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
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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
...and 19 more locations
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.
Time frame: Week 54
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at 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.
Time frame: Week 54