Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease - Study Results

Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

This study has been completed.

Study NCT00356408 Information provided by UCB, Inc.

First Received on July 25, 2006. Last Updated on August 30, 2011 History of Changes

Results First Received: February 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Crohn's Disease
Intervention:	Biological: Certolizumab pegol

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CDP870 400 mg	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

Participant Flow: Overall Study

	CDP870 400 mg
STARTED	103 ^[1]
COMPLETED	43
NOT COMPLETED	60
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

[1]	106 subjects enrolled, however only 103 were included in the Intent to Treat (ITT) population.

Baseline Characteristics

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Reporting Groups

	Description
Placebo/Completer	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 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 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 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).

Baseline Measures

	Placebo/Completer	CDP870/Completer	Placebo/Non-completer	CDP870/Non-completer	Total
Number of Participants [units: participants]	14	16	40	33	103
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	14	16	39	32	101
>=65 years	0	0	1	1	2
Age [units: years] Mean ± Standard Deviation	44.00 ± 12.53	39.31 ± 12.83	38.44 ± 13.73	41.38 ± 13.75	40.27 ± 13.39
Gender [units: participants]
Female	6	9	22	18	55
Male	8	7	18	15	48
Region of Enrollment [units: participants]
United States	8	10	31	21	70
Canada	4	6	7	10	27
Germany	2	0	2	2	6

Outcome Measures

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1. Primary:

Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) [ Time Frame: During this study (maximum 122 weeks) ]

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2. Secondary:

Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids. [ Time Frame: Week 34 in this study ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00356408 History of Changes
Other Study ID Numbers:	C87065
Study First Received:	July 25, 2006
Results First Received:	February 23, 2011
Last Updated:	August 30, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Canada: Health Canada