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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00333788
First received: June 2, 2006
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Biological: Certolizumab pegol (CDP870)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]

    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.


  • 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] ] [ Designated as safety issue: No ]

    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.


  • 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] ] [ Designated as safety issue: No ]

    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.


  • 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] ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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).


  • Occurrence of at Least 1 Hospital Stay During the Treatment Period [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Hospital Stay During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Hospital Stay During the During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.


  • Length of Hospital Stays During the Treatment Period [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]
    The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

  • Length of Hospital Stays During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]
    Follow-up period starts the day after the last injection up to 84 days after last injection.

  • Length of Hospital Stays During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]
    Overall period corresponds to both treatment and follow-up periods in C87046.

  • Occurrence of at Least 1 Emergency Room Visit During the Treatment Period [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Emergency Room Visit During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 General Concomitant Medication During the Treatment Period [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 General Concomitant Medication During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. [ Time Frame: Maximum 152 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period [ Time Frame: Maximum 12 weeks ] [ Designated as safety issue: No ]

    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.


  • Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period [ Time Frame: Maximum 164 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 233
Study Start Date: October 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CDP870
  • Cimzia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333788

  Show 65 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00333788     History of Changes
Other Study ID Numbers: C87046, 2006-001729-24
Study First Received: June 2, 2006
Results First Received: April 13, 2011
Last Updated: August 30, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
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)
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
CDP870
Cimzia

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014