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

Rheumatoid Arthritis Clinical Trial

Official title:

Remicade Treatment Registry in Rheumatoid Arthritis I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724243
• Other study ID #: P04741
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 3, 2015
• Start date: January 2006
• Est. completion date: October 2008

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Infliximab
Infliximab given in accordance with the local summary of product characteristics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment	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.	Baseline, Week 14, and Week 54	No
Primary	Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria	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.	Week 14 and Week 54	No