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

May 29, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with a confirmed diagnosis of rheumatoid arthritis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
All Participants
Adults with a confirmed diagnosis of rheumatoid arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Day of enrollment (Day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of participants with rheumatoid arthritis visiting participating sites in the course of one year
Time Frame: One year
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)
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)
Day of enrollment (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe