Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 348
- Primary Endpoint
- Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Study Overview
Brief Summary
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
Detailed Description
This study population was chosen from a non-probability sample
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with active luminal and/or fistulizing CD.
Exclusion Criteria
- •Per summary of product characteristics.
Outcomes
Primary Outcomes
Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Time Frame: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Time Frame: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Average Dose of Infliximab Per Participant Within the Observation Period
Time Frame: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Median Dose of Infliximab Per Participant Within the Observation Period
Time Frame: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Total Dose of Infliximab Per Participant Within the Observation Period
Time Frame: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Secondary Outcomes
- Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.(5 years)