Trial record 1 of 1 for:
NCT00356408
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)
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| ClinicalTrials.gov Identifier: NCT00356408 |
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Recruitment Status :
Completed
First Posted : July 26, 2006
Results First Posted : May 25, 2011
Last Update Posted : August 9, 2018
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Crohn's Disease |
| Intervention |
Biological: Certolizumab pegol |
| Enrollment | 106 |
Participant Flow
| Recruitment Details | The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010. |
| Pre-assignment Details |
| Arm/Group Title | CDP870 400 mg |
|---|---|
 Arm/Group Description |
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2 |
| Period Title: Overall Study | |
| Started | 103 [1] |
| Completed | 43 |
| Not Completed | 60 |
| Reason Not Completed | |
| Adverse Event | 9 |
| Lack of Efficacy | 36 |
| Lost to Follow-up | 2 |
| Withdrawal by Subject | 6 |
| Other: Principal investigator discretion | 3 |
| Other: Sponsor request | 1 |
| Other: Azathioprine stopped | 1 |
| Other: Failed to meet Inc/Exc criteria | 1 |
| Other: Subject chose commerical dosing | 1 |
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[1]
106 subjects enrolled, however only 103 were included in the Intent to Treat (ITT) population.
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Baseline Characteristics
| Arm/Group Title | Placebo/Completer | CDP870/Completer | Placebo/Non-completer | CDP870/Non-completer | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. | CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059. | Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). | CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 14 | 16 | 40 | 33 | 103 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 14 participants | 16 participants | 40 participants | 33 participants | 103 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
14 100.0%
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16 100.0%
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39 97.5%
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32 97.0%
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101 98.1%
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| >=65 years |
0 0.0%
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0 0.0%
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1 2.5%
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1 3.0%
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2 1.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 14 participants | 16 participants | 40 participants | 33 participants | 103 participants | |
| 44.00 (12.53) | 39.31 (12.83) | 38.44 (13.73) | 41.38 (13.75) | 40.27 (13.39) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 14 participants | 16 participants | 40 participants | 33 participants | 103 participants | |
| Female |
6 42.9%
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9 56.3%
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22 55.0%
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18 54.5%
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55 53.4%
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| Male |
8 57.1%
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7 43.8%
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18 45.0%
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15 45.5%
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48 46.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 14 participants | 16 participants | 40 participants | 33 participants | 103 participants |
| United States | 8 | 10 | 31 | 21 | 70 | |
| Canada | 4 | 6 | 7 | 10 | 27 | |
| Germany | 2 | 0 | 2 | 2 | 6 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
| Name/Title: | UCB (Study Director) |
| Organization: | UCB Clinical Trial Call Center |
| Phone: | +1 887 822 9493 |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00356408 |
| Other Study ID Numbers: |
C87065 2006-003871-11 ( EudraCT Number ) |
| First Submitted: | July 25, 2006 |
| First Posted: | July 26, 2006 |
| Results First Submitted: | February 23, 2011 |
| Results First Posted: | May 25, 2011 |
| Last Update Posted: | August 9, 2018 |