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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705289
First received: June 23, 2008
Last updated: June 30, 2014
Last verified: June 2014
  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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • Baseline Raw DAS28 by Time Since Diagnosis [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • Baseline Raw DAS28 by Gender [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • Baseline Raw DAS28 by Country of Residence [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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


Enrollment: 728
Study Start Date: December 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705289     History of Changes
Other Study ID Numbers: P04250
Study First Received: June 23, 2008
Results First Received: September 3, 2009
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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 July 23, 2014