Treatment With Infliximab in a Medical Setting (Study P05587)(COMPLETED) (OPTIMIST)

This study has been terminated.

(Factors that led to termination: recruitment challenges and a lower incidence of flares than estimated, causing a high risk of the study being underpowered.)

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00752622

First received: September 12, 2008

Last updated: July 28, 2011

Last verified: July 2011

History of Changes

Results First Received: June 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Crohn's Disease
Interventions:	Biological: Infliximab 5 mg/kg Biological: Infliximab 5 mg/kg every 6 weeks Biological: Infliximab 7 mg/kg every 8 weeks

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 100 enrolled participants, 2 participants experienced a protocol violation that excluded them from the Eligible (ELIG) population, thus, the ELIG population comprised of 98 participants. Due to early study termination, all 8 randomized participants received at least one infusion of interventional treatment, but none completed the trial.

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

Of the 100 enrolled participants, 2 participants experienced a protocol violation that excluded them from the Eligible (ELIG) population, thus, the ELIG population comprised of 98 participants.

Due to early study termination, all 8 randomized participants received at least one infusion of interventional treatment, but none completed the trial.

Reporting Groups

	Description
Infliximab	Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.

Participant Flow for 3 periods

Period 1: Induction Phase

	Infliximab
STARTED	100 ^[1]
COMPLETED	65
NOT COMPLETED	35
Adverse Event	3
Unspecified	3
Non-responder	14
Withdrawal by Subject	1
Premature study termination	14

[1]	The ELIG population comprised of 98 participants

Period 2: Observational Phase

	Infliximab
STARTED	65
COMPLETED	22 ^[1]
NOT COMPLETED	43
Premature Study Termination	36
Non-responder	2
Withdrawal by Subject	2
Adverse Event	1
Unspecified	2

[1]	14 completed without loss of response 8 had loss of response & randomized into interventional phase

Period 3: Interventional Phase

	Infliximab
STARTED	8 ^[1]
COMPLETED	0 ^[2]
NOT COMPLETED	8
Non-responder	2
Physician Decision	1
Premature Study Termination	5

[1]	5 participants randomized into increased dose group and 3 randomized into shortened interval group
[2]	8 participants received at least 1 infusion of interventional treatment, but none completed trial

Baseline Characteristics

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Reporting Groups

	Description
Infliximab	Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.

Baseline Measures

	Infliximab
Number of Participants [units: participants]	100
Age ^[1] [units: years] Mean ± Standard Deviation	38.4 ± 13.16
Gender, Customized [units: participants]
Female	54
Male	44
Excluded from analysis	2

[1]	The mean age at baseline within the population of all eligible (ELIG) participants (Overall= 98).

Outcome Measures

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1. Primary:

Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase [ Time Frame: Baseline and Week 24 of the Interventional phase ]

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2. Primary:

Mean Change From Baseline in Harvey-Bradshaw Index (HBI) [ Time Frame: Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase ]

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3. Secondary:

Number of Participants That Required Treatment Optimization in the Observational Phase [ Time Frame: Week 54 in the Observational Phase ]

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4. Secondary:

Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase [ Time Frame: Baseline and Weeks 14-16 and 48 in the Interventional Phase ]

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5. Secondary:

Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase [ Time Frame: Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase ]

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6. Secondary:

Number of Participants Who Had Clinical Remission in the Interventional Phase [ Time Frame: Weeks 14-16, 24 and 48 in the Interventional Phase ]

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7. Secondary:

Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase [ Time Frame: Weeks 14-16, 24 and 48 in the Interventional Phase ]

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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: Prior to submission for publication of results obtained in this study, written permission is required. Draft manuscripts, abstracts & presentations should be submitted for review & approval. Schering-Plough Canada will retain the ownership of the data obtained in this study. Authorship of publications resulting from this study should accurately reflect the academic contribution of individuals to the design and implementation of the study, analysis of the data and preparation of the manuscript.

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
Due to early study termination, no statistical analysis was performed for the interventional part of this study, therefore, endpoints dedicated to this phase of the study have not been analyzed.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00752622 History of Changes
Other Study ID Numbers:	P05587
Study First Received:	September 12, 2008
Results First Received:	June 23, 2011
Last Updated:	July 28, 2011
Health Authority:	Canada: Health Canada

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