Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Other: PlaceboBiological: certolizumab pegol (CDP870, CZP)
- Registration Number
- NCT00552058
- Lead Sponsor
- UCB Pharma
- Brief Summary
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
- male/female
- 18 - 75 years inclusive
- diagnosis of Crohn's disease confirmed
- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, saline solution for sc injection Certolizumab pegol certolizumab pegol (CDP870, CZP) Certolizumab pegol 400 mg for subcutaneous (sc) injection
- Primary Outcome Measures
Name Time Method Percentage of Subjects in Clinical Remission at Week 6 Week 6 The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Achieving a Clinical Response at Week 6 Week 0, Week 6 The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 Week 6 The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 Week 0 to Week 6 The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 Week 0 to Week 6 The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Percentage of Subjects in Clinical Remission at Week 2 Week 2 The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Clinical Remission at Week 4 Week 4 The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects Achieving a Clinical Response at Week 2 Week 0, Week 2 The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects Achieving a Clinical Response at Week 4 Week 0, Week 4 The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 Week 0 to Week 2 The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 Week 0, Week 4 The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 Week 2 The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 Week 4 The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 Week 6 The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 Week 6 The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 Week 0, Week 6 The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 Week 0, Week 6 The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.