Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
2 other identifiers
interventional
539
14 countries
107
Brief Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2006
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2006
CompletedFirst Posted
Study publicly available on registry
March 29, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
November 17, 2009
CompletedAugust 7, 2018
April 1, 2011
2 years
March 28, 2006
July 7, 2009
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. 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.
Baseline to Week 6
Secondary Outcomes (64)
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Baseline to Week 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Baseline to Week 6
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Baseline to Week 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Week 26
- +59 more secondary outcomes
Other Outcomes (1)
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Week 6 to Week 26
Study Arms (2)
Active 1
EXPERIMENTALQ4W regimen \- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Active 2
EXPERIMENTALQ2W regimen \- every 2 weeks: 400 mg Certolizumab Pegol
Interventions
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Eligibility Criteria
You may qualify if:
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
You may not qualify if:
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (107)
Unknown Facility
San Francisco, California, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
Great Neck, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
Kingsport, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Galveston, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Innsbruck, Austria
Unknown Facility
Oberpullendorf, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Bonheiden, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Genk, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Kortrijk, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Roeselare, Belgium
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Richmond, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Calgary, Canada
Unknown Facility
Aalborg, Denmark
Unknown Facility
Aarhus, Denmark
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Herlev, Denmark
Unknown Facility
Amiens, France
Unknown Facility
Clichy, France
Unknown Facility
Grenoble, France
Unknown Facility
Lille, France
Unknown Facility
Montpellier, Cédex 5, France
Unknown Facility
Nice, Cedex 3, France
Unknown Facility
Paris, France
Unknown Facility
Pessac, France
Unknown Facility
Rouen, France
Unknown Facility
Toulouse, France
Unknown Facility
Berlin, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Herne, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Minden, Germany
Unknown Facility
Munich, Germany
Unknown Facility
München, Germany
Unknown Facility
Bari, Italy
Unknown Facility
Bologna, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Padua, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Roma, Italy
Unknown Facility
Torino, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Eindhoven, Netherlands
Unknown Facility
Enschede, Netherlands
Unknown Facility
Heerlen, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Terneuven, Netherlands
Unknown Facility
Zwolle, Netherlands
Unknown Facility
Oslo, Norway
Unknown Facility
Tromsø, Norway
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Oviedo, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Malmo, Sweden
Unknown Facility
Örebro, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Basel, Switzerland
Unknown Facility
Bern, Switzerland
Unknown Facility
Lausanne, Switzerland
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Cambridge, United Kingdom
Unknown Facility
Edinburgh, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Oxford, United Kingdom
Unknown Facility
Sheffield, United Kingdom
Related Publications (3)
Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
PMID: 20925993BACKGROUNDSandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
PMID: 20451663RESULTFeagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
PMID: 21223344RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 28, 2006
First Posted
March 29, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 7, 2018
Results First Posted
November 17, 2009
Record last verified: 2011-04