DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Infliximab (Biological)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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)

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Mean Remicade Dose Per Participant

Median Remicade Dose Per Participant

Secondary outcome:

Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy

Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)

Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Severe RA (indication according to Austrian labeling).

Exclusion Criteria:

- According to Summary of Product Characteristics (SPC).

Locations and Contacts

Additional Information

Starting date: March 2004
Last updated: October 29, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017