Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

• ClinicalTrials.gov Identifier: NCT00308581
• Recruitment Status: Completed
• First Posted: March 29, 2006
• Results First Posted: November 17, 2009
• Last Update Posted: August 7, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

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

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: Certolizumab pegol; Other: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 539 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: April 2006
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

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: CDP870; Cimzia; 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, Q2W, administered 2-weekly; Other Names: CDP870; Cimzia

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Baseline to Week 6 ]

   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.

Secondary Outcome Measures :

1. Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
   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.
2. Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase [ Time Frame: Baseline to Week 6 ]
   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.
3. Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
   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.
4. Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase [ Time Frame: Week 6 ]
   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.
5. Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
   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.
6. CDAI Score at Week 2 of the Induction Phase [ Time Frame: Week 2 ]
   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.
7. CDAI Score at Week 4 of the Induction Phase [ Time Frame: Week 4 ]
   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.
8. CDAI Score at Week 6 of the Induction Phase [ Time Frame: Week 6 ]
   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.
9. CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ]
   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.
10. CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 ]
    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.
11. CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ]
    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.
12. CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 14 ]
    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.
13. CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ]
    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.
14. CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 ]
    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.
15. CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ]
    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.
16. CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 ]
    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.
17. CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ]
    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.
18. CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
    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.
19. Change From Baseline in CDAI Score at Week 2 of the Induction Phase [ Time Frame: Baseline to Week 2 ]
    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.
20. Change From Baseline in CDAI Score at Week 4 of the Induction Phase [ Time Frame: Baseline to Week 4 ]
    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.
21. Change From Baseline in CDAI Score at Week 6 of the Induction Phase [ Time Frame: Baseline to Week 6 ]
    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.
22. Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 8 ]
    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.
23. Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 10 ]
    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.
24. Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 12 ]
    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.
25. Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 14 ]
    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.
26. Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 16 ]
    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.
27. Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 18 ]
    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.
28. Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 20 ]
    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.
29. Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 22 ]
    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.
30. Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 24 ]
    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.
31. Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ]
    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.
32. 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. [ Time Frame: Week 10 ]
    Remission is defined as CDAI score ≤ 150.
33. 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. [ Time Frame: Week 12 ]
    Remission is defined as CDAI score ≤ 150.
34. 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. [ Time Frame: Week 14 ]
    Remission is defined as CDAI score ≤ 150.
35. 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. [ Time Frame: Week 16 ]
    Remission is defined as CDAI score ≤ 150.
36. 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. [ Time Frame: Week 18 ]
    Remission is defined as CDAI score ≤ 150.
37. 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. [ Time Frame: Week 20 ]
    Remission is defined as CDAI score ≤ 150.
38. 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. [ Time Frame: Week 22 ]
    Remission is defined as CDAI score ≤ 150.
39. 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. [ Time Frame: Week 24 ]
    Remission is defined as CDAI score ≤ 150.
40. 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. [ Time Frame: Week 26 ]
    Remission is defined as CDAI score ≤ 150.
41. 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. [ Time Frame: Week 10 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
42. 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. [ Time Frame: Week 12 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
43. 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. [ Time Frame: Week 14 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
44. 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. [ Time Frame: Week 16 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
45. 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. [ Time Frame: Week 18 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
46. 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. [ Time Frame: Week 20 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
47. 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. [ Time Frame: Week 22 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
48. 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. [ Time Frame: Week 24 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
49. 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. [ Time Frame: Week 26 ]
    Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
50. C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase [ Time Frame: Week 0 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
51. CRP Level at Week 2 of the Induction Phase [ Time Frame: Week 2 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
52. CRP Level at Week 4 of the Induction Phase [ Time Frame: Week 4 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
53. CRP Level at Week 6 of the Induction Phase [ Time Frame: Week 6 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
54. CRP Level at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
55. CRP Level at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
56. CRP Level at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
57. CRP Level at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 14 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
58. CRP Level at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
59. CRP Level at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
60. CRP Level at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
61. CRP Level at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 (optional measurement) ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
62. CRP Level at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
63. CRP Level at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ]
    High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
64. CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase [ Time Frame: Last visit on or before Week 26 ]
    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.

Other Outcome Measures:

1. Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 [ Time Frame: Week 6 to Week 26 ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

San Francisco, California, United States

United States, Florida

Gainesville, Florida, United States

United States, Georgia

Atlanta, Georgia, United States

United States, Illinois

Chicago, Illinois, United States

United States, Indiana

Indianapolis, Indiana, United States

United States, Kentucky

Lexington, Kentucky, United States

Louisville, Kentucky, United States

United States, Louisiana

Baton Rouge, Louisiana, United States

United States, Maryland

Baltimore, Maryland, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, Minnesota

Rochester, Minnesota, United States

United States, Nebraska

Lincoln, Nebraska, United States

United States, New York

Great Neck, New York, United States

New York, New York, United States

United States, North Carolina

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

United States, Ohio

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

United States, Oklahoma

Oklahoma City, Oklahoma, United States

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

United States, South Carolina

Charleston, South Carolina, United States

United States, Tennessee

Germantown, Tennessee, United States

Kingsport, Tennessee, United States

Nashville, Tennessee, United States

United States, Texas

Dallas, Texas, United States

Galveston, Texas, United States

Houston, Texas, United States

United States, Washington

Seattle, Washington, United States

United States, Wisconsin

Milwaukee, Wisconsin, United States

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, Alberta

Edmonton, Alberta, Canada

Canada, British Columbia

Vancouver, British Columbia, Canada

Canada, Ontario

London, Ontario, Canada

Richmond, Ontario, Canada

Toronto, Ontario, Canada

Canada

Calgary, 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

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications of Results:

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.

Other 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.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00308581
• Other Study ID Numbers: C87042; Eudract number: 2005-004104-37
• First Posted: March 29, 2006
• Results First Posted: November 17, 2009
• Last Update Posted: August 7, 2018
• Last Verified: April 2011

Keywords provided by UCB Pharma:

Crohn's Disease; Certolizumab pegol

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Certolizumab Pegol; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents