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Completed

NCT Number: NCT00333788

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol (CDP870)

Biological

400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks

Other names: CDP870, Cimzia

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Acronym: Welcome2

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 6, 2006
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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