Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (Welcome2)

July 10, 2018 updated by: UCB Pharma

Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

233

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

  • Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Belgium
      • Bonheiden, Belgium
      • Brussels, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Canada
      • Calgary, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • France
      • Clichy, France
      • Lille, France
      • Nice Cedex 3, France
      • Paris, France
      • Pessac, France
  • Germany
      • Berlin, Germany
      • Hamburg, Germany
      • Herne, Germany
      • Kiel, Germany
      • Leipzig, Germany
      • Minden, Germany
      • Munich, Germany
      • München, Germany
  • Italy
      • Bologna, Italy
      • Milano, Italy
      • Padova, Italy
      • Palermo, Italy
      • Roma, Italy
      • Torino, Italy
  • Netherlands
      • Eindhoven, Netherlands
      • Heerlen, Netherlands
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Santiago de Compostela, Spain
      • Sevilla, Spain
      • Valencia, Spain
  • Sweden
      • Stockholm, Sweden
  • Switzerland
      • Bern, Switzerland
      • Lausanne, Switzerland
  • United Kingdom
      • Bristol, United Kingdom
      • London, United Kingdom
      • Oxford, United Kingdom
  • United States
    • Florida
      • Gainesville, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charleston, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having completed study C87042 [NCT00308581] (previously treated with infliximab)

Exclusion Criteria:

  • Subject withdraw from C87042 [NCT00308581] study
  • Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study
  • Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
  • Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certolizumab pegol 400 mg
400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Biological: Certolizumab pegol (CDP870)
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
Other Names:
  • Cimzia
  • CDP870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Time Frame: Maximum 164 weeks

Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.

Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Maximum 164 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Time Frame: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.

A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects maintaining response at Last visit.
Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time Frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects achieving clinical response at Last visit.
Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time Frame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects in remission at Last visit.
Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time Frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Time Frame: Maximum 154 weeks

Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)

Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
Maximum 154 weeks
Occurrence of at Least 1 Hospital Stay During the Treatment Period
Time Frame: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
Maximum 152 weeks
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Time Frame: Maximum 12 weeks

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Maximum 12 weeks
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Time Frame: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
Maximum 164 weeks
Length of Hospital Stays During the Treatment Period
Time Frame: Maximum 152 weeks
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Maximum 152 weeks
Length of Hospital Stays During the Follow-Up Period
Time Frame: Maximum 12 weeks
Follow-up period starts the day after the last injection up to 84 days after last injection.
Maximum 12 weeks
Length of Hospital Stays During the Overall Period
Time Frame: Maximum 164 weeks
Overall period corresponds to both treatment and follow-up periods in C87046.
Maximum 164 weeks
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
Time Frame: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
Maximum 152 weeks
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Time Frame: Maximum 12 weeks

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
Maximum 12 weeks
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Time Frame: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
Maximum 164 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
Time Frame: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
Maximum 152 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Time Frame: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
Maximum 12 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Time Frame: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
Maximum 164 weeks
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
Time Frame: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
Maximum 152 weeks
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Time Frame: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
Maximum 12 weeks
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Time Frame: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
Maximum 164 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
Time Frame: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
Maximum 152 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Time Frame: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
Maximum 12 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Time Frame: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.
Maximum 164 weeks

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.

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

October 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C87046
  • 2006-001729-24 (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.

Subscribe