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

Brief Summary:
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

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
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.
Drug: Infliximab
Infliximab given in accordance with the local summary of product characteristics
Other Names:
  • Remicade
  • SCH 215596

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects for this study will be patients expecting to initiate infliximab, for the first time, for the diagnoses of rheumatoid arthritis at the National Institute of Rheumatology Diseases in Piestany, Slovakia.

Inclusion Criteria:

  • Subject must have been given patient leaflet,
  • Subject must not have ever received infliximab at the time of registration,
  • Subject must be a good candidate for infliximab as per Summary of Product Characteristics
  • Subject must sign the approved consent form

Exclusion Criteria:

  • None
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00724243    
Other Study ID Numbers: P04741
First Posted: July 29, 2008    Key Record Dates
Results First Posted: February 19, 2010
Last Update Posted: September 4, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents