A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease (PRECiSE 4)

July 10, 2018 updated by: UCB Pharma SA

A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

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
        • 11009
      • Fremantle, Australia
        • 11010
      • Garran, Australia
        • 11015
      • Newtown, Australia
        • 11018
    • New South Wales
      • Bankstown, New South Wales, Australia
        • 11011
      • New Lambton, New South Wales, Australia
        • 11005
    • Queensland
      • Herston, Queensland, Australia
        • 11017
      • South Brisbane, Queensland, Australia
        • 11006
    • Tasmania
      • Lauceston, Tasmania, Australia
        • 11014
    • Victoria
      • Ballarat, Victoria, Australia
        • 11016
      • Box Hill, Victoria, Australia
        • 11007
      • Fitzroy, Victoria, Australia
        • 11002
      • Frankston, Victoria, Australia
        • 11013
      • Parkville, Victoria, Australia
        • 11012
  • Austria
      • Linz, Austria
        • 46006
      • Salzburg, Austria
        • 46003
      • Wien, Austria
        • 46002
  • Belarus
      • Minsk, Belarus
        • 12001
  • Belgium
      • Brussels, Belgium
        • 13004
      • Gent, Belgium
        • 13001
      • Leuven, Belgium
        • 13003
  • Bulgaria
      • Sofia, Bulgaria
        • 15001
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 16005
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 16014
    • Ontario
      • Toronto, Ontario, Canada
        • 16013
    • Quebec
      • Montreal, Quebec, Canada
        • 16008
  • Czechia
      • Hradek Kralove, Czechia
        • 18006
      • Ostrava, Czechia
        • 18001
      • Praha 2, Czechia
        • 18004
      • Praha 4, Czechia
        • 18002
  • Denmark
      • Aalborg, Denmark
        • 19004
      • Copenhagen, Denmark
        • 19009
      • Herlev, Denmark
        • 19010
      • Hvidovre, Denmark
        • 19007
      • Vejle, Denmark
        • 19003
  • Estonia
      • Tallin, Estonia
        • 20001
      • Tartu, Estonia
        • 20002
  • Germany
      • Berlin, Germany
        • 22002
      • Berlin, Germany
        • 22009
      • Celle, Germany
        • 22004
      • Frankfurt, Germany
        • 22019
      • Göttingen, Germany
        • 22013
      • Hannover, Germany
        • 22017
      • Kiel, Germany
        • 22015
      • Leipzig, Germany
        • 22016
      • Minden, Germany
        • 22001
      • Munich, Germany
        • 22012
      • Münster, Germany
        • 22008
  • Hungary
      • Budapest, Hungary
        • 24002
      • Pecs, Hungary
        • 24009
      • Szekszard, Hungary
        • 24011
  • Israel
      • Beer Sheva, Israel
        • 26004
      • Haifa, Israel
        • 26007
      • Petha Tikva, Israel
        • 26005
  • Italy
      • Milano, Italy
        • 27001
      • Palermo, Italy
        • 27004
      • Roma, Italy
        • 27007
  • New Zealand
      • Auckland, New Zealand
        • 31002
      • Christchurch, New Zealand
        • 31001
      • Hamilton, New Zealand
        • 31005
      • Milford, New Zealand
        • 31004
      • Tauranga, New Zealand
        • 31003
  • Norway
      • Oslo, Norway
        • 32005
      • Oslo, Norway
        • 32008
      • Tromso, Norway
        • 32004
  • Poland
      • Bydgoszcz, Poland
        • 33008
      • Gdansk, Poland
        • 33003
      • Lublin, Poland
        • 33018
      • Szczecin, Poland
        • 33013
      • Warsaw, Poland
        • 33007
      • Warszawa, Poland
        • 33009
  • Russian Federation
      • Lipetsk, Russian Federation
        • 34017
      • Moscow, Russian Federation
        • 34006
      • Nizhny Novgorod, Russian Federation
        • 34016
      • St. Petersburg, Russian Federation
        • 34001
      • St. Petersburg, Russian Federation
        • 34005
      • St. Petersburg, Russian Federation
        • 34007
      • St. Petersburg, Russian Federation
        • 34013
  • Serbia
      • Belgrade, Serbia
        • 35001
      • Belgrade, Serbia
        • 35002
      • Belgrade, Serbia
        • 35004
  • Singapore
      • Singapore, Singapore
        • 36002
  • Slovenia
      • Celje, Slovenia
        • 38001
      • Ljubljana, Slovenia
        • 38003
  • South Africa
      • Cape Town, South Africa
        • 39016
      • Cape Town, South Africa
        • 39018
      • Goodwood, South Africa
        • 39012
      • Johannesburg, South Africa
        • 39010
      • Midrand, South Africa
        • 39008
      • PORT Elisabeth, South Africa
        • 39004
      • Pretoria, South Africa
        • 39006
      • Pretoria, South Africa
        • 39009
      • Pretoria, South Africa
        • 39014
      • Pretoria, South Africa
        • 39019
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • 39013
    • Somerset West
      • Cape Town, Somerset West, South Africa
        • 39003
  • Spain
      • Barcelona, Spain
        • 40009
  • Ukraine
      • Dniepropetrovsk, Ukraine
        • 43008
      • Lviv, Ukraine
        • 43003
      • Odessa, Ukraine
        • 43006
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 45102
      • Huntsville, Alabama, United States
        • 45028
    • Arkansas
      • Little Rock, Arkansas, United States
        • 45044
    • California
      • Orange, California, United States
        • 45095
      • San Francisco, California, United States
        • 45101
    • Colorado
      • Colorado Springs, Colorado, United States
        • 45130
    • Florida
      • Gainesville, Florida, United States
        • 45094
      • Hialeah, Florida, United States
        • 45005
      • Miami, Florida, United States
        • 45087
      • North Miami Beach, Florida, United States
        • 45004
    • Illinois
      • Chicago, Illinois, United States
        • 45016
    • Indiana
      • Indianapolis, Indiana, United States
        • 45037
    • Kentucky
      • Lexington, Kentucky, United States
        • 45019
    • Maryland
      • Chevy Chase, Maryland, United States
        • 45033
      • Laurel, Maryland, United States
        • 45013
    • Minnesota
      • Rochester, Minnesota, United States
        • 45083
    • Missouri
      • Jefferson City, Missouri, United States
        • 45108
    • New Jersey
      • Berlin, New Jersey, United States
        • 45035
    • New York
      • Great Neck, New York, United States
        • 45009
      • New York, New York, United States
        • 45070
    • North Carolina
      • Greenville, North Carolina, United States
        • 45145
      • High Point, North Carolina, United States
        • 45067
      • Raleigh, North Carolina, United States
        • 45003
      • Winston-Salem, North Carolina, United States
        • 45040
    • Ohio
      • Cincinnati, Ohio, United States
        • 45081
      • Cincinnati, Ohio, United States
        • 45091
      • Dayton, Ohio, United States
        • 45054
      • Mayfield Heights, Ohio, United States
        • 45025
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 45039
      • Tulsa, Oklahoma, United States
        • 45041
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • 45093
    • Tennessee
      • Germantown, Tennessee, United States
        • 45113
      • Nashville, Tennessee, United States
        • 45119
    • Texas
      • Houston, Texas, United States
        • 45022
      • San Antonio, Texas, United States
        • 45073
    • Utah
      • Salt Lake City, Utah, United States
        • 45139
      • South Ogden, Utah, United States
        • 45052
    • Virginia
      • Charlottesville, Virginia, United States
        • 45134
      • Christiansburg, Virginia, United States
        • 45078
      • Norfolk, Virginia, United States
        • 45109
    • Washington
      • Seattle, Washington, United States
        • 45141

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):

    1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870 032 [NCT00152425] responders) OR
    2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032 [NCT00152425] responders) with an absolute score of at least 350 points
  • Subjects must be able to understand the information provided to them and give written informed consent

Exclusion Criteria:

  • Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]), although the upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certolizumab Pegol
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Biological: Certolizumab Pegol (CDP870)

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.

Up to 84 months of therapy in this study.

Other Names:
  • Cimzia
  • CZP
  • CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)
Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)
Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
HBI remission is defined as total HBI score of 4 points or less. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032
Time Frame: From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034
Time Frame: From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034
Time Frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Time Frame: Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256

Collaborators and Investigators

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

Sponsor

UCB Pharma SA

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

February 1, 2004

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C87034
  • 2005-002623-13 (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.

Clinical Trials on Crohn's Disease

Clinical Trials on Certolizumab Pegol (CDP870)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe