Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553 AM2) (MUNIX)

This study has been terminated.

(Due to slow recruitment the study was stopped prematurely.)

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00984568

First received: September 24, 2009

Last updated: April 25, 2013

Last verified: April 2013

History of Changes

Results First Received: February 19, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colitis, Ulcerative
Interventions:	Biological: Infliximab Drug: Prednisolone Drug: 5-aminosalicylic acid Drug: Azathioprine

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
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Reporting Groups

	Description
Top-Hold	Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
Step-Up	Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.

Participant Flow: Overall Study

	Top-Hold	Step-Up
STARTED	15	13
COMPLETED	7	7
NOT COMPLETED	8	6
Withdrawal by Subject	1	2
Lack of Efficacy	2	0
Adverse Event	2	0
Did Not Meet Randomization Criteria	1	0
Lost to Follow-up	0	1
Opportunistic Infection	1	0
Unknown Reason	1	3

Baseline Characteristics

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Reporting Groups

	Description
Top-Hold	Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
Step-Up	Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Total	Total of all reporting groups

Baseline Measures

	Top-Hold	Step-Up	Total
Number of Participants [units: participants]	15	13	28
Age [units: years] Mean ± Standard Deviation	39.9 ± 15.2	41.6 ± 15.3	40.7 ± 15.0
Gender [units: participants]
Female	10	7	17
Male	5	6	11

Outcome Measures

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1. Primary:

Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50 [ Time Frame: Week 50 ]

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2. Secondary:

Number of Participants Achieving Treatment Response [ Time Frame: Up to Week 4 ]

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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: The investigator agrees to provide the sponsor 45 days prior to publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor has the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis with respect to: proprietary information, accuracy, and fair balance.

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 slow recruitment the study was stopped prematurely; participants on study at that time continued to receive treatment per protocol.

Results Point of Contact:

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

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00984568 History of Changes
Other Study ID Numbers:	P05553, 2009-010065-23
Study First Received:	September 24, 2009
Results First Received:	February 19, 2013
Last Updated:	April 25, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

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