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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00984568
First received: September 24, 2009
Last updated: April 28, 2014
Last verified: April 2014
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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 Sharp & Dohme Corp.
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 28, 2014
Health Authority: Germany: Paul-Ehrlich-Institut