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

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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Certolizumab pegol; Biological: Certolizumab pegol; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 539
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
  • Oberpullendorf, Austria
  • Wien, Austria
• Belgium
  • Bonheiden, Belgium
  • Brussels, Belgium
  • Genk, Belgium
  • Gent, Belgium
  • Kortrijk, Belgium
  • Leuven, Belgium
  • Liege, Belgium
  • Roeselare, Belgium
• Canada
  • Calgary, Canada
  • Alberta
    • Edmonton, Alberta, Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
  • Ontario
    • London, Ontario, Canada
    • Richmond, Ontario, Canada
    • Toronto, Ontario, Canada
• Denmark
  • Aalborg, Denmark
  • Arhus, Denmark
  • Copenhagen, Denmark
  • Herlev, Denmark
• France
  • Amiens, France
  • Clichy, France
  • Grenoble, Cedex 9, France
  • Lille, France
  • Montpellier, Cédex 5, France
  • Nice, France, Cedex 3
  • Paris, France
  • Pessac, France
  • Rouen, France
  • Toulouse, Cedex 9, France
• Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Hannover, Germany
  • Herne, Germany
  • Kiel, Germany
  • Leipzig, Germany
  • Minden, Germany
  • Munchen, Germany
  • Munich, Germany
• Italy
  • Bari, Italy
  • Bologna, Italy
  • Milano, Italy
  • Padova, Italy
  • Palermo, Italy
  • Roma, Italy
  • Torino, Italy
• Netherlands
  • Amsterdam, Netherlands
  • Eindhoven, Netherlands
  • Enschede, Netherlands
  • Heerlen, Netherlands
  • Leiden, Netherlands
  • Terneuven, Netherlands
  • Zwolle, Netherlands
• Norway
  • Oslo, Norway
  • Tromso, Norway
• Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Oviedo, Spain
  • Santiago De Compostela, Spain
  • Sevilla, Spain
  • Valencia, Spain
• Sweden
  • Goteborg, Sweden
  • Malmo, Sweden
  • Orebro, Sweden
  • Stockholm, Sweden
• Switzerland
  • Basel, Switzerland
  • Bern, Switzerland
  • Lausanne, Switzerland
• United Kingdom
  • Bristol, United Kingdom
  • Cambridge, United Kingdom
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Nottingham, United Kingdom
  • Oxford, United Kingdom
  • Sheffield, United Kingdom
• United States
  • California
    • San Francisco, California, United States
  • Florida
    • Gainesville, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Kentucky
    • Lexington, Kentucky, United States
    • Louisville, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Minnesota
    • Rochester, Minnesota, United States
  • Nebraska
    • Lincoln, Nebraska, United States
  • New York
    • Great Neck, New York, United States
    • New York, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Charlotte, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Cleveland, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
  • Tennessee
    • Germantown, Tennessee, United States
    • Kingsport, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Galveston, Texas, United States
    • Houston, Texas, United States
  • Washington
    • Seattle, Washington, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with Crohn's Disease
• Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active 1; Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol	Biological: Certolizumab pegol; 400mg Certolizumab Pegol, Q4W, administered 4-weekly; Other Names: Cimzia; CDP870; Biological: Certolizumab pegol; 400mg Certolizumab Pegol, Q2W, administered 2-weekly; Other Names: Cimzia; CDP870; Other: Placebo; placebo administered 4-weekly in Active 1
Experimental: Active 2; Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol	Biological: Certolizumab pegol; 400mg Certolizumab Pegol, Q4W, administered 4-weekly; Other Names: Cimzia; CDP870; Biological: Certolizumab pegol; 400mg Certolizumab Pegol, Q2W, administered 2-weekly; Other Names: Cimzia; CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase	Response is defined as at least 100 point decrease in CDAI score from baseline. 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 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase	Response is defined as at least 70 points reduction in CDAI score. 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
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase	Response is defined as at least 70 points reduction in CDAI score. 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 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase	Remission is defined as CDAI score ≤ 150. 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.	Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase	Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms 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.	Week 26
CDAI Score at Week 2 of the Induction Phase	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.	Week 2
CDAI Score at Week 4 of the Induction Phase	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.	Week 4
CDAI Score at Week 6 of the Induction Phase	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.	Week 6
CDAI Score at Week 8 in the Randomized Maintenance Phase	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.	Week 8
CDAI Score at Week 10 in the Randomized Maintenance Phase	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.	Week 10
CDAI Score at Week 12 in the Randomized Maintenance Phase	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.	Week 12
CDAI Score at Week 14 in the Randomized Maintenance Phase	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.	Week 14
CDAI Score at Week 16 in the Randomized Maintenance Phase	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.	Week 16
CDAI Score at Week 18 in the Randomized Maintenance Phase	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.	Week 18
CDAI Score at Week 20 in the Randomized Maintenance Phase	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.	Week 20
CDAI Score at Week 22 in the Randomized Maintenance Phase	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.	Week 22
CDAI Score at Week 24 in the Randomized Maintenance Phase	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.	Week 24
CDAI Score at Week 26 in the Randomized Maintenance Phase	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.	Week 26
Change From Baseline in CDAI Score at Week 2 of the Induction Phase	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 2
Change From Baseline in CDAI Score at Week 4 of the Induction Phase	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 4
Change From Baseline in CDAI Score at Week 6 of the Induction Phase	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
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase	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 8
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase	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 10
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase	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 12
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase	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 14
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase	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 16
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase	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 18
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase	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 20
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase	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 22
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase	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 24
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase	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 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Remission is defined as CDAI score ≤ 150.	Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 26
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 0
CRP Level at Week 2 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 2
CRP Level at Week 4 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 4
CRP Level at Week 6 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 6
CRP Level at Week 8 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 8
CRP Level at Week 10 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 10 (optional measurement)
CRP Level at Week 12 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 12
CRP Level at Week 14 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 14 (optional measurement)
CRP Level at Week 16 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 16
CRP Level at Week 18 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 18 (optional measurement)
CRP Level at Week 20 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 20
CRP Level at Week 22 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 22 (optional measurement)
CRP Level at Week 24 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 24
CRP Level at Week 26 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 26
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.	Last visit on or before Week 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6	Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.	Week 6 to Week 26

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.
• Sandborn 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.
• Feagan 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 28, 2006
• First Submitted That Met QC Criteria: March 28, 2006
• First Posted (Estimate): March 29, 2006

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Crohn's Disease; Certolizumab pegol
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Certolizumab Pegol
• Other Study ID Numbers: C87042; Eudract number: 2005-004104-37