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Assessment of the Disease Severity and Treatment Patterns of Rheumatoid Arthritis in Eastern Europe, Middle East and North African Countries (P08167)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313871
First Posted: March 14, 2011
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The study will assess the disease severity and treatment patterns of rheumatoid arthritis in Eastern European, Middle Eastern, and North African countries.

Condition
Arthritis, Rheumatoid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study of Disease Severity and Treatment Patterns of Rheumatoid Arthritis, in Eastern Europe Middle East and North Africa

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with low, moderate, or high disease activity as assessed by the Disease Activity Score using 28 joint counts (DAS28) [ Time Frame: Day of enrollment (Day 0) ]

Secondary Outcome Measures:
  • The number of participants with rheumatoid arthritis visiting participating sites in the course of one year [ Time Frame: One year ]
  • Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ). [ Time Frame: Day of enrollment (Day 0) ]
  • Number of participants treated with non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDS), corticosteroids, and/or biologics [ Time Frame: Day of enrollment (Day 0) ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Participants
Adults with a confirmed diagnosis of rheumatoid arthritis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with a confirmed diagnosis of rheumatoid arthritis
Criteria

Inclusion Criteria :

  • Confirmed diagnosis of rheumatoid arthritis, preferably based upon criteria established by the American College of Rheumatology (ACR) 1987
  • clinical signs & symptoms
  • data obtained from previous laboratory and instrumental examination, which may include but is not limited to: Radiography, Blood tests
  • Written informed consent, signed before participation in the study.

Exclusion Criteria :

  • Refusal to participate in the study
  • Age under 18 years
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01313871     History of Changes
Other Study ID Numbers: P08167
First Submitted: March 10, 2011
First Posted: March 14, 2011
Last Update Posted: June 1, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases