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

NCT00724243 | Completed Results

• 1 other identifier: P04741
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

Infliximab DRUG

Infliximab given in accordance with the local summary of product characteristics

Also known as: Remicade, SCH 215596

Rheumatoid Arthritis Patients in Slovakia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: January 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 4, 2015
• Results First Posted: February 19, 2010

Record last verified: 2015-09