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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724243
First received: July 25, 2008
Last updated: October 31, 2014
Last verified: October 2014

July 25, 2008
October 31, 2014
January 2006
October 2008   (final data collection date for primary outcome measure)
  • Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment [ Time Frame: Baseline, Week 14, and Week 54 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Joint assessment (swollen and tender), Physician's Global Assessment by Visual Analog Scale (VAS), ESR, CRP, rheumatoid factor, morning stiffness, patient assessment of pain and disease (VAS and Health Assessment Questionnaire), ACR20 [ Time Frame: according to study protocol ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00724243 on ClinicalTrials.gov Archive Site
Not Provided
Serious Adverse Events and Adverse events reported [ Time Frame: At the end of patient's treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)
Remicade Treatment Registry in Rheumatoid Arthritis I

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Rheumatoid Arthritis
Drug: Infliximab
Infliximab given in accordance with the local summary of product characteristics
Other Names:
  • Remicade
  • SCH 215596
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.
Intervention: Drug: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00724243
P04741
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP