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

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ClinicalTrials.gov Identifier: NCT00705289
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 10, 2010
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: Infliximab

Study Type : Observational
Actual Enrollment : 728 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice
Study Start Date : December 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Infliximab used in line with current clinical practice and local guidelines.
Other Names:
  • Remicade®
  • SCH 215596



Primary Outcome Measures :
  1. Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age [ Time Frame: At Baseline ]
    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.

  2. Baseline Raw DAS28 by Time Since Diagnosis [ Time Frame: At Baseline ]
    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.

  3. Baseline Raw DAS28 by Gender [ Time Frame: At Baseline ]
    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.

  4. Baseline Raw DAS28 by Country of Residence [ Time Frame: At Baseline ]
    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.

  5. Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy [ Time Frame: At Baseline ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood and Urine samples


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 12 countries, including: Austria, Belgium, Denmark, France, Greece, the 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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705289     History of Changes
Other Study ID Numbers: P04250
First Posted: June 26, 2008    Key Record Dates
Results First Posted: June 10, 2010
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents