Rheumatoid Arthritis Clinical Trial
Official title:
Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy
Verified date | September 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Not Required |
Study type | Observational |
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)
Status | Completed |
Enrollment | 516 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Severe RA (indication according to Austrian labeling). Exclusion Criteria: - According to Summary of Product Characteristics (SPC). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. | Centocor, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks | No |
Primary | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks | No |
Primary | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks | No |
Primary | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks | No |
Primary | Mean Remicade Dose Per Participant | Maximum of 102 weeks | No | |
Primary | Median Remicade Dose Per Participant | Maximum of 102 weeks | No | |
Secondary | Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy | 24 months maximum | No | |
Secondary | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Some participants had more than one previous treatment with a DMARD. | 24 months maximum | No |
Secondary | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | 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. | 24 months maximum | No |
Secondary | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | 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. | 24 months maximum | No |
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