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

Rheumatoid Arthritis Clinical Trial

Official title:

Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725621
• Other study ID #: P03756
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 2, 2015
• Start date: March 2004
• Est. completion date: July 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Not Required
• Study type: Observational

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• 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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Infliximab
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 given in doses and intervals due to discretion of physicians.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

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