Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
This study has been terminated.
(Study was terminated early because of slow recruitment)
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00307931
First received: March 24, 2006
Last updated: August 30, 2011
Last verified: December 2009
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Purpose
An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Biological: Certolizumab pegol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Secondary Outcome Measures:
- Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal [ Time Frame: Baseline to Weeks 1, and 14 or Withdrawal ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
- Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14 [ Time Frame: Baseline to Weeks 1, 6 and 14 ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
- Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal [ Time Frame: Weeks 1, 6 and 14 or Withdrawal ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
- Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
- Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
- C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]
- Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.
- Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
- Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
- Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
- Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
| Enrollment: | 16 |
| Study Start Date: | April 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Certolizumab pegol
certolizumab pegol 400 mg
|
Biological: Certolizumab pegol
certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12. Treatment duration: 12 weeks. Other Name: Cimzia
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant
Exclusion Criteria:
- Symptomatic obstructive intestinal strictures
- Bowel resection within 4 weeks
- Current total parenteral nutrition
- Short bowel syndrome
- Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307931
Locations
| Greece | |
| Heraclion, Crete, Greece | |
| Athens, Greece | |
| Ioannina, Greece | |
| Piraeus, Greece | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00307931 History of Changes |
| Other Study ID Numbers: | C87055, Eudract n° - 2006-002027-16 |
| Study First Received: | March 24, 2006 |
| Results First Received: | September 8, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by UCB, Inc.:
|
Certolizumab pegol Cimzia Crohn's disease Greek patients |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Infliximab Immunoglobulin Fab Fragments |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013