Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

This study has been terminated.
(Study enrollment was stopped due to insufficient subject accrual.)
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00394589
First received: October 31, 2006
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: October 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Infliximab Increased Frequency
Drug: Infliximab Increased Dose
Drug: Infliximab Control

  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
Increased Dose 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
Increased Frequency Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Control Continuation of infliximab 3 mg/kg every 8 weeks

Participant Flow:   Overall Study
    Increased Dose     Increased Frequency     Control  
STARTED     14     11     18  
COMPLETED     6     8     11  
NOT COMPLETED     8     3     7  
Adverse Event                 2                 1                 2  
Lack of Efficacy                 2                 2                 3  
Protocol Violation                 4                 0                 2  



  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
Increased Dose 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
Increased Frequency Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Control Continuation of infliximab 3 mg/kg every 8 weeks
Total Total of all reporting groups

Baseline Measures
    Increased Dose     Increased Frequency     Control     Total  
Number of Participants  
[units: participants]
  14     11     18     43  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 13.0     58.6  ± 16.1     57.7  ± 12.3     58.3  ± 13.3  
Gender  
[units: participants]
       
Female     11     9     14     34  
Male     3     2     4     9  



  Outcome Measures

1.  Primary:   Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.   [ Time Frame: Between Screening (Week <=1) and Week 24 ]


  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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00394589     History of Changes
Other Study ID Numbers: P04249
Study First Received: October 31, 2006
Results First Received: October 28, 2009
Last Updated: April 30, 2014
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Paul-Ehrlich-Institut
Greece: Ministry of Health and Welfare
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Sweden: Medical Products Agency
Turkey: Ministry of Health