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

Arthritis, Rheumatoid Clinical Trial

Official title:

Cross-sectional Study of Disease Severity and Treatment Patterns of Rheumatoid Arthritis, in Eastern Europe Middle East and North Africa

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01313871
• Other study ID #: P08167
• Status: Withdrawn
• Phase: N/A
• First received: March 10, 2011
• Last updated: May 29, 2015
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with low, moderate, or high disease activity as assessed by the Disease Activity Score using 28 joint counts (DAS28)		Day of enrollment (Day 0)	No
Secondary	The number of participants with rheumatoid arthritis visiting participating sites in the course of one year		One year	No
Secondary	Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ).		Day of enrollment (Day 0)	No
Secondary	Number of participants treated with non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDS), corticosteroids, and/or biologics		Day of enrollment (Day 0)	No