Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724243
First received: July 25, 2008
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: January 28, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Drug: Infliximab

  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
Infliximab Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.

Participant Flow:   Overall Study
    Infliximab  
STARTED     33  
COMPLETED     18  
NOT COMPLETED     15  
Lack of Efficacy                 10  
Adverse Event                 5  



  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.
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Reporting Groups
  Description
Infliximab Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.

Baseline Measures
    Infliximab  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Mean ± Standard Deviation
  43.38  ± 10.74  
Gender  
[units: participants]
 
Female     26  
Male     7  
Region of Enrollment  
[units: participants]
 
Slovakia     33  



  Outcome Measures
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1.  Primary:   Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment   [ Time Frame: Baseline, Week 14, and Week 54 ]

2.  Primary:   Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria   [ Time Frame: Week 14 and Week 54 ]


  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 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: NCT00724243     History of Changes
Other Study ID Numbers: P04741
Study First Received: July 25, 2008
Results First Received: January 28, 2010
Last Updated: April 29, 2014
Health Authority: Slovakia: State Institute for Drug Control