Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
- Conditions
- Rheumatoid Arthritis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- Severe RA (indication according to Austrian labeling).
- According to Summary of Product Characteristics (SPC).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Remicade Dose Per Participant Maximum of 102 weeks 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.
- Secondary Outcome Measures
Name Time Method Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy 24 months maximum 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.
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.