Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00724243|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : February 19, 2010
Last Update Posted : September 4, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Infliximab|
Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Remicade Treatment Registry in Rheumatoid Arthritis I|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Rheumatoid Arthritis Patients in Slovakia
Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
Infliximab given in accordance with the local summary of product characteristics
Primary Outcome Measures :
- Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment [ Time Frame: Baseline, Week 14, and Week 54 ]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.
- 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 ]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.
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