Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00724243
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : February 19, 2010
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Drug: Infliximab
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Period Title: Overall Study
Started 33
Completed 18
Not Completed 15
Reason Not Completed
Lack of Efficacy             10
Adverse Event             5
Arm/Group Title Infliximab
Hide Arm/Group Description Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
43.38  (10.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
26
  78.8%
Male
7
  21.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovakia Number Analyzed 33 participants
33
1.Primary Outcome
Title Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment
Hide Description The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.
Time Frame Baseline, Week 14, and Week 54
Hide Outcome Measure Data
Hide Analysis Population Description

Thirty-three participants had a DAS 28 score at the beginning of treatment.

Twenty-eight participants had a DAS 28 score at Week 14.

Twenty-two participants had a DAS 28 score at Week 54.

Arm/Group Title Infliximab
Hide Arm/Group Description:
Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline 7.11  (0.65)
Week 14 2.94  (1.22)
Week 54 3.27  (1.59)
2.Primary Outcome
Title Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria
Hide Description Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
Time Frame Week 14 and Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab
Hide Arm/Group Description:
Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Participants
Week 14 27
Week 54 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab
Hide Arm/Group Description Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
All-Cause Mortality
Infliximab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Infliximab
Affected / at Risk (%) # Events
Total   0/33 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab
Affected / at Risk (%) # Events
Total   4/33 (12.12%)    
General disorders   
Allergic reactions to infusion   4/33 (12.12%)  4
Indicates events were collected by systematic assessment
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.
Contractor agrees to acknowledge his contractual relationship with Sponsor in his lecturing or publication activities in relation to subject matter and/or in relation to any other matter concerning Sponsor. However, unless Sponsor's prior consent was given, Contractor shall not specify in more detail the content or subject matter of his contract. Contractor shall not publish or provide to 3rd parties for publication purposes any results of his activities without Sponsor's prior written consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724243    
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