A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705289

Purpose

This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.

Condition	Intervention
Rheumatoid Arthritis	Biological: Infliximab

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Disease Activity Score based on the assessment of 28 joints (DAS28) at Baseline [ Time Frame: DAS28 is measured at Baseline, Week 2, Week 6, and Week 14. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood and Urine samples

Enrollment:	694
Study Start Date:	November 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
RA Subjects Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).	Biological: Infliximab Infliximab used in line with current clinical practice and local guidelines.

Eligibility

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

Study Population

Subjects will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®).

Subjects will be recruited from approximately 11 countries, including: Austria, Belgium, Denmark, , Greece, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.

Criteria

Inclusion Criteria:

Subject has been diagnosed with RA
Physician has decided, with the subject's consent, to begin treatment with infliximab
Written informed consent form signed by both the subject and the physician.

Exclusion Criteria:

Subjects who have previously been exposed to infliximab

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04250
Study First Received:	June 23, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00705289
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Infliximab
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009