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

Sponsor:	Schering-Plough
Collaborator:	Centocor, Inc.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00725621

Purpose

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)

Condition	Intervention
Rheumatoid Arthritis	Biological: Infliximab

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 16 weeks ] [ Designated as safety issue: No ]
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 16 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Maximum of 102 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Maximum of 102 weeks ] [ Designated as safety issue: No ]
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Remicade Dose Per Participant [ Time Frame: Maximum of 102 weeks ] [ Designated as safety issue: No ]
Median Remicade Dose Per Participant [ Time Frame: Maximum of 102 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy [ Time Frame: 24 months maximum ] [ Designated as safety issue: No ]
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) [ Time Frame: 24 months maximum ] [ Designated as safety issue: No ]
Some participants had more than one previous treatment with a DMARD.
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) [ Time Frame: 24 months maximum ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 months maximum ] [ Designated as safety issue: No ]
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.

Enrollment:	516
Study Start Date:	March 2004
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Remicade Patients with severe RA (indication according to Austrian labeling) will receive 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. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.	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. Other Names: Remicade SCH 215596

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with severe RA being treated at specialized centers.

Criteria

Inclusion Criteria:

Severe RA (indication according to Austrian labeling).

Exclusion Criteria:

According to Summary of Product Characteristics (SPC).

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00725621 History of Changes
Other Study ID Numbers:	P03756
Study First Received:	July 25, 2008
Results First Received:	July 8, 2011
Last Updated:	July 8, 2011
Health Authority:	Austria: Not Required

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012