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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00308581

First received: March 28, 2006

Last updated: August 30, 2011

Last verified: April 2011

History of Changes

Purpose

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	Intervention	Phase
Crohn's Disease	Biological: Certolizumab pegol Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
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.
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
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.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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.
CDAI Score at Week 2 of the Induction Phase [ Time Frame: Week 2 ] [ 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.
CDAI Score at Week 4 of the Induction Phase [ Time Frame: Week 4 ] [ 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.
CDAI Score at Week 6 of the Induction Phase [ Time Frame: 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.
CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ] [ 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.
CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 ] [ 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.
CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ] [ 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.
CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 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.
CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ] [ 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.
CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 ] [ 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.
CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ] [ 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.
CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 ] [ 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.
CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ] [ 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.
CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ] [ 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 CDAI Score at Week 2 of the Induction Phase [ Time Frame: Baseline to Week 2 ] [ 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 CDAI Score at Week 4 of the Induction Phase [ Time Frame: Baseline to Week 4 ] [ 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 CDAI Score at Week 6 of the Induction Phase [ Time Frame: Baseline to 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.
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 8 ] [ 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 CDAI Score at Week 10 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 10 ] [ 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 CDAI Score at Week 12 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 12 ] [ 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 CDAI Score at Week 14 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 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 CDAI Score at Week 16 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 16 ] [ 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 CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 18 ] [ 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 CDAI Score at Week 20 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 20 ] [ 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 CDAI Score at Week 22 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 22 ] [ 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 CDAI Score at Week 24 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 24 ] [ 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 CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: Baseline to Week 26 ] [ 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 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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Remission is defined as CDAI score ≤ 150.
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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 ] [ Designated as safety issue: No ]
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 2 of the Induction Phase [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 4 of the Induction Phase [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 6 of the Induction Phase [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 8 in the Randomized Maintenance Phase [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 10 in the Randomized Maintenance Phase [ Time Frame: Week 10 (optional measurement) ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 12 in the Randomized Maintenance Phase [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 14 in the Randomized Maintenance Phase [ Time Frame: Week 14 (optional measurement) ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 16 in the Randomized Maintenance Phase [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 18 in the Randomized Maintenance Phase [ Time Frame: Week 18 (optional measurement) ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 20 in the Randomized Maintenance Phase [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 22 in the Randomized Maintenance Phase [ Time Frame: Week 22 (optional measurement) ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 24 in the Randomized Maintenance Phase [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 26 in the Randomized Maintenance Phase [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase [ Time Frame: Last visit on or before Week 26 ] [ Designated as safety issue: No ]
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.

Enrollment:	539
Study Start Date:	April 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308581

Show 107 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

Publications:

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. 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. Epub 2011 Jan 12.

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.

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00308581 History of Changes
Other Study ID Numbers:	C87042, Eudract number: 2005-004104-37
Study First Received:	March 28, 2006
Results First Received:	July 7, 2009
Last Updated:	August 30, 2011
Health Authority:	Austria: Federal Ministry for Health and Women Belgium: Directorate general for the protection of Public health: Medicines Canada: Health Canada Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Spain: Ministry of Health Sweden: Medical Products Agency Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Crohn's Disease
Certolizumab pegol

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 23, 2013

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