Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Infliximab

• Registration Number: NCT00725621
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Detailed Description

This study population was chosen from a non-probability sample.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-08
• Results First Submitted QC: 2011-07-08
• Results First Posted: 2011-08-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

• Severe RA (indication according to Austrian labeling).

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Exclusion Criteria

• According to Summary of Product Characteristics (SPC).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remicade	Infliximab	Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.

Primary Outcome Measures

Name	Time	Method
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy	Maximum of 16 weeks	The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy	Maximum of 102 weeks	The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy	Maximum of 102 weeks	The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Remicade Dose Per Participant	Maximum of 102 weeks
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy	Maximum of 16 weeks	The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Remicade Dose Per Participant	Maximum of 102 weeks

Secondary Outcome Measures

Name	Time	Method
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)	24 months maximum	Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS	24 months maximum	Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy	24 months maximum
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	24 months maximum	Some participants had more than one previous treatment with a DMARD.