Rheumatoid ArthritisNCT01044823
Use of Thermal and 3D Imaging to Quantify Arthritis
An observational study of Rheumatoid Arthritis and Juvenile Rheumatoid Arthritis, run by University of Pittsburgh at 1 site in United States.
Trial summary
One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis
- What is being tested?
- 3D and thermal imaging
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2014
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with JRA adults with RA
Who may be able to join
- at least 4 years of age
Who cannot join
- less than 4 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.
- Being tested
- 3D and thermal imaging
- Keywords
- RA, JRA
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D and thermal imagingOther
subjects will be imaged before and after receiving DMARD therapy
| Study group | Role | What they receive |
|---|---|---|
| Adult RA | Not described Receives: Other: 3D and thermal imaging | |
| pediatric JRA | Not described Receives: Other: 3D and thermal imaging |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionJan 2014
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.
- More trials run by University of PittsburghThe 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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044823
- Sponsor's protocol ID
- PRO08040135
- Other IDs
- R21AR056690
- Status last verified
- Feb 2011
- First submitted
- 6 Jan 2010
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Thermal and 3D Imaging to Quantify Arthritis
- ClinicalTrials.gov ID
- NCT01044823
- Acronym / sponsor ID
- PRO08040135
- Keywords
- RA, JRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Jan 2010 (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.
One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult RA | – | Other: 3D and thermal imaging |
| pediatric JRA | – | Other: 3D and thermal imaging |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with JRA adults with RA
Key inclusion criteria (1 listed)
- at least 4 years of age
Key exclusion criteria (1 listed)
- less than 4 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D and thermal imagingsubjects will be imaged before and after receiving DMARD therapy | Other | Adult RA, pediatric JRA |
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 31 Jul 2017.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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 Rheumatoid Arthritis and Juvenile Rheumatoid Arthritis, run by University of Pittsburgh 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 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 31 Jul 2017. 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?
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 31 Jul 2017.