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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724243
First Posted: July 29, 2008
Last Update Posted: September 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: 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 
Overall Participants Analyzed 
[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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724243     History of Changes
Other Study ID Numbers: P04741
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: January 28, 2010
Results First Posted: February 19, 2010
Last Update Posted: September 4, 2015