A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

NCT00705289 | Completed Results

• 1 other identifier: P04250
• Study Type: observational
• Target: 728
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age

  Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.

  At Baseline

• Baseline Raw DAS28 by Time Since Diagnosis

  Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.

  At Baseline

• Baseline Raw DAS28 by Gender

  Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.

  At Baseline

• Baseline Raw DAS28 by Country of Residence

  Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.

  At Baseline

• Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

  Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.

  At Baseline

Study Arms (1)

RA Subjects/ Infliximab 3 mg/kg

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

Interventions

Infliximab BIOLOGICAL

Infliximab used in line with current clinical practice and local guidelines.

Also known as: Remicade®, SCH 215596

RA Subjects/ Infliximab 3 mg/kg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 12 countries, including: Austria, Belgium, Denmark, France, Greece, the Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who have previously been exposed to infliximab

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11.

  PMID: 24529163 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine samples

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: December 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 30, 2015
• Results First Posted: June 10, 2010

Record last verified: 2015-07