FatigueNCT01697202
Fatigue in Rheumatoid Arthritis - Longitudinal Study
An observational study of Fatigue and Rheumatoid Arthritis, run by Göteborg University at 1 site in Sweden.
Trial summary
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatigue, Rheumatoid Arthritis
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg, Sweden
Who may be able to join
- Diagnose of RA, age 20-65 years,
Who cannot join
- other serious physical or mental illness
Trial locations and contacts
1 site in 1 country.
About this study
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.
- Conditions
- Fatigue, Rheumatoid Arthritis
- Medical subject headings
- Fatigue, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
patient administered questionnaire
Measured: 4 times during the course of the study up to one year
Secondary outcomes (4)
Pain
patient administered questionnaire
Measured: 4 times during the course of the study up to one year
Activity limitations
patient administered questionnaire
Measured: 4 times during the course of the study up to one year
Disease activity
Tender and swollen joint count, patient-rated global health, inflammation parameters (DAS-28)
Measured: 4 times during the course of the study up to one year
Health related quality of life
patient administered questionnaire
Measured: 4 times during the course of the study upto one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697202
- Sponsor's protocol ID
- GoteborgU
- Status last verified
- Feb 2014
- First submitted
- 29 Aug 2012
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Rheumatoid Arthritis - Longitudinal Study
- ClinicalTrials.gov ID
- NCT01697202
- Acronym / sponsor ID
- GoteborgU
- Conditions
- Fatigue, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no intervention | – | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with RA at the Rheumatology clinic at Sahlgrenska University hospital Gothenburg, Sweden
Key inclusion criteria (1 listed)
- Diagnose of RA, age 20-65 years,
Key exclusion criteria (1 listed)
- other serious physical or mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 4 times during the course of the study up to one year
patient administered questionnaire
4 secondary outcomes
Pain
Time frame: 4 times during the course of the study up to one year
Activity limitations
Time frame: 4 times during the course of the study up to one year
Disease activity
Time frame: 4 times during the course of the study up to one year
Health related quality of life
Time frame: 4 times during the course of the study upto one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Rheumatoid Arthritis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 4 times during the course of the study up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.