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

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. Identifier: NCT01313871
Recruitment Status : Withdrawn
First Posted : March 14, 2011
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The study will assess the disease severity and treatment patterns of rheumatoid arthritis in Eastern European, Middle Eastern, and North African countries.

Condition or disease
Arthritis, Rheumatoid

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : August 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

All Participants
Adults with a confirmed diagnosis of rheumatoid arthritis

Primary Outcome Measures :
  1. 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 :
  1. The number of participants with rheumatoid arthritis visiting participating sites in the course of one year [ Time Frame: One year ]
  2. Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ). [ Time Frame: Day of enrollment (Day 0) ]
  3. 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) ]

Information from the National Library of Medicine

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

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

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

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