Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

July 10, 2018 updated by: UCB Pharma

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Bankstown, Australia
      • Clayton, Australia
      • Fitzroy, Australia
      • Fremantle, Australia
      • Garran, Australia
    • New South Wales
      • Concord, New South Wales, Australia
    • Victoria
      • Box Hill, Victoria, Australia
      • Footscray, Victoria, Australia
      • Parkville, Victoria, Australia
  • Austria
      • Wien, Austria
  • Belgium
      • Bonheiden, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Brazil
      • Curitiba, Brazil
      • Goiania, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil
      • Santo-Andre, Brazil
      • Santos, Brazil
      • Sao Paulo, Brazil
    • MG
      • Belo-Horizonte, MG, Brazil
  • Canada
      • Calgary, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • Chile
      • Santiago, Chile
      • Vina del Mar, Chile
  • Czechia
      • Hradec Kralove, Czechia
      • Hradek Kralove, Czechia
      • Praha 7, Czechia
      • Usti Nad Orlici, Czechia
      • Zlin, Czechia
  • Estonia
      • Tallin, Estonia
      • Tartu, Estonia
  • Finland
      • Mikkeli, Finland
  • Germany
      • Berlin, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Homburg, Germany
      • Jena, Germany
      • Kiel, Germany
      • Munchen, Germany
      • Ulm, Germany
      • Wilhelmshaven, Germany
  • Hungary
      • Budapest, Hungary
      • Gyor, Hungary
      • Nagykanizsa, Hungary
      • Szeged, Hungary
      • Szombathely, Hungary
  • Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petha Tikva, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Zerifin, Israel
  • Italy
      • Bologna, Italy
      • Padova, Italy
      • Roma, Italy
  • Latvia
      • Riga, Latvia
      • Valmiera, Latvia
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
    • Auckland
      • Milford, Auckland, New Zealand
    • Wellington
      • Newton, Wellington, New Zealand
  • Poland
      • Czestochowa, Poland
      • Lodz, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Romania
      • Bucharest, Romania
      • Cluj Napoca, Romania
      • Constanta, Romania
  • Russian Federation
      • Kazan, Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Ukraine
      • Dniepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Simferopol, Ukraine
  • United States
    • Alabama
      • Pell City, Alabama, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Lakewood, Colorado, United States
      • Littleton, Colorado, United States
    • Florida
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • New Port Richey, Florida, United States
      • Winter Park, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
      • Monroe, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Towson, Maryland, United States
    • Michigan
      • Chesterfield, Michigan, United States
      • West Bloomfield, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male/female
  • 18 - 75 years inclusive
  • diagnosis of Crohn's disease confirmed
  • moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
  • no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

  • previous participation in a certolizumab pegol study
  • general exclusion criteria as common for studies in this indication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Biological: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Other Names:
  • CZP
  • CDP870
  • CIMZIA ®
Placebo Comparator: Placebo
Placebo, saline solution for sc injection
Other: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Clinical Remission at Week 6
Time Frame: Week 6
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving a Clinical Response at Week 6
Time Frame: Week 0, Week 6
The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Time Frame: Week 6
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Time Frame: Week 0 to Week 6
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Time Frame: Week 0 to Week 6
The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
Time Frame: Week 2
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 2
Percentage of Subjects in Clinical Remission at Week 4
Time Frame: Week 4
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
Time Frame: Week 0, Week 2
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
Time Frame: Week 0, Week 4
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Time Frame: Week 0 to Week 2
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Time Frame: Week 0, Week 4
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Time Frame: Week 2
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Time Frame: Week 4
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 4
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Time Frame: Week 6
The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Time Frame: Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Time Frame: Week 0, Week 6
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Time Frame: Week 0, Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 1, 2007

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C87085
  • 2007-001913-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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