Rheumatoid ArthritisNCT00471874
Study Evaluating Health Related Utility in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 4 sites in Australia.
Trial summary
The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 250 participants
- Where
- 4 sitesAustralia
- Study dates
- Apr 2007to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months
- Age 18 years or older
- Ability to complete the study documents in English
Who cannot join
- Current participation in a blinded trial of an investigational treatment
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Study site
Darlinghurst, New South Wales, 2010
Study site
Malvern, Victoria, 3144
Study site
Maroochydore, Queensland, 4558
Study site
Wollongong, New South Wales, 2500
About this study
Official title: An Observational Study to Examine the Relationship Between Rheumatoid Arthritis Disease Severity and Health Related Utility
The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.
Read the detailed description
At a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. The questionnaire will take them about 30 minutes to complete. A blood test may also be required.
This ends the patient's involvement with the study.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startApr 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Australia, medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471874
- Sponsor's protocol ID
- 0881X1-4427
- Status last verified
- Dec 2007
- First submitted
- 8 May 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Examine the Relationship Between Rheumatoid Arthritis Disease Severity and Health Related Utility
- ClinicalTrials.gov ID
- NCT00471874
- Acronym / sponsor ID
- 0881X1-4427
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 10 May 2007 (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.
The purpose of this study is to determine in Australia what effect rheumatoid arthritis has on quality of life, and also to determine the costs that are associated with having rheumatoid arthritis.
Detailed description
At a routine visit to the clinic, patients will be asked to answer questions about their symptoms, have a routine examination by the doctor, fill out a questionnaire that will ask questions about them, about their arthritis, about how it affects their well being and quality of life, and about treatment and costs. The questionnaire will take them about 30 minutes to complete. A blood test may also be required.
This ends the patient's involvement with the study.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient with clinically defined rheumatoid arthritis diagnosed for at least 3 months
- Age 18 years or older
- Ability to complete the study documents in English
Key exclusion criteria (1 listed)
- Current participation in a blinded trial of an investigational treatment
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
Not reported in the source record.
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 13 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Australia, medinfo@wyeth.com
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 4 sites in Australia.
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 3 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 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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.
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 13 Dec 2007.