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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01313871
First received: March 10, 2011
Last updated: June 23, 2014
Last verified: June 2014
  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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of participants with rheumatoid arthritis visiting participating sites in the course of one year [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ). [ Time Frame: Day of enrollment (Day 0) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01313871     History of Changes
Other Study ID Numbers: P08167
Study First Received: March 10, 2011
Last Updated: June 23, 2014
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014