NCT01313871

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

March 10, 2011

Last Update Submit

May 29, 2015

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • The number of participants with rheumatoid arthritis visiting participating sites in the course of one year

    One year

  • Number of participants with different degrees of disability as assessed by the Health Assessment Questionnaire (HAQ).

    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

    Day of enrollment (Day 0)

Study Arms (1)

All Participants

Adults with a confirmed diagnosis of rheumatoid arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with a confirmed diagnosis of rheumatoid arthritis

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate in the study
  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 14, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

November 1, 2012

Last Updated

June 1, 2015

Record last verified: 2015-05