NCT02008266

Brief Summary

This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

November 27, 2013

Last Update Submit

December 6, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.

    Single observational visit [Day 1]

Secondary Outcomes (3)

  • Measure disease activity using DAS 28 assessment.

    Single observational visit [Day 1]

  • Assess joint damage using the modified SHARP method.

    Single observational visit [Day 1]

  • Assess functional status of patients using the Health Assessment Questionnaire (HAQ).

    Single observational visit [Day 1]

Study Arms (1)

Patients with Rheumatoid Arthritis

Eligibility Criteria

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

Patients with Rheumatoid Arthritis that has been progressing for \> 3 months and \< 2 years.

You may qualify if:

  • Rheumatoid arthritis progressing for \< 2 years.

You may not qualify if:

  • Rheumatoid arthritis progressing for \< 3 months.
  • Rheumatoid arthritis onset at \< 18 years of age.
  • Participation in another clinical study.
  • Rheumatoid arthritis related connective tissue disorder.
  • Any neuropsychological disorders.

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 11, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 11, 2013

Record last verified: 2013-12