Joint PainNCT01341314
Finding Early Rheumatoid Arthritis
An observational study of Joint Pain and Stiffness, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Pain, Stiffness
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- 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
Study population: persons with joint pain or swelling for less than 3 months
Who may be able to join
- Joint pain or swelling for less than 3 months
- Be able to use the internet
Who cannot join
- Non English speaking
- Diagnosis of rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Proof of Concept of an Internet-based Series Design Case-finding System for Very Early Rheumatoid Arthritis.
Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up.
This study will recruit persons who've gone to the internet looking for information about their symptoms. After answering a screening survey, the person with possible symptoms will be linked to the study website for a more detailed symptom questionnaire.
Read more
After completing that questionnaire the person will receive information about the second part of the study which includes an examination with a rheumatologist (arthritis doctor)and laboratory tests.
Based on the joint examination and laboratory tests, the rheumatologist will tell the person the likelihood of having RA, and make recommendations and if needed a referral for care and treatment. Treatment is not a part of this study.
This study will also compare the information on the subject's questionnaires to the doctor's joint examination and the laboratory tests with the hope of developing a simple inexpensive case finding questionnaire.
- Conditions
- Joint Pain, Stiffness
- Keywords
- joint pain, stiffness
- Medical subject headings
- Arthralgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew H. Liang, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341314
- Sponsor's protocol ID
- ArthFndtn
- Status last verified
- May 2012
- First submitted
- 22 Apr 2011
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept of an Internet-based Series Design Case-finding System for Very Early Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT01341314
- Acronym / sponsor ID
- ArthFndtn
- Conditions
- Joint Pain, Stiffness
- Keywords
- joint pain, stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 25 Apr 2011 (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.
Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up.
This study will recruit persons who've gone to the internet looking for information about their symptoms. After answering a screening survey, the person with possible symptoms will be linked to the study website for a more detailed symptom questionnaire.
After completing that questionnaire the person will receive information about the second part of the study which includes an examination with a rheumatologist (arthritis doctor)and laboratory tests.
Based on the joint examination and laboratory tests, the rheumatologist will tell the person the likelihood of having RA, and make recommendations and if needed a referral for care and treatment. Treatment is not a part of this study.
This study will also compare the information on the subject's questionnaires to the doctor's joint examination and the laboratory tests with the hope of developing a simple inexpensive case finding questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persons with joint pain or swelling for less than 3 months
Key inclusion criteria (2 listed)
- Joint pain or swelling for less than 3 months
- Be able to use the internet
Key exclusion criteria (2 listed)
- Non English speaking
- Diagnosis of rheumatoid arthritis
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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 Joint Pain and Stiffness, run by Brigham and Women's Hospital at 1 site in United States.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 2012. 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 United States. 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?
Results are not available in the source record.
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 24 May 2012.