NCT01697202

Brief Summary

To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

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

November 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
2 months 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
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

August 29, 2012

Last Update Submit

February 19, 2014

Conditions

FatigueRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    patient administered questionnaire

    4 times during the course of the study up to one year

Secondary Outcomes (4)

  • Pain

    4 times during the course of the study up to one year

  • Activity limitations

    4 times during the course of the study up to one year

  • Disease activity

    4 times during the course of the study up to one year

  • Health related quality of life

    4 times during the course of the study upto one year

Study Arms (1)

no intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg, Sweden

You may qualify if:

  • Diagnose of RA, age 20-65 years,

You may not qualify if:

  • other serious physical or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

FatigueArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

October 2, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

SE(1)