Arthritis, RheumatoidNCT02813083
Detection of Pathological Lymphocytes in Patients With Autoimmune Disease
An observational study of Arthritis, Rheumatoid, run by University of Minnesota at 1 site in United States.
Trial summary
This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2023
- How long will I take part?
- 5 Years
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will enroll 155 rheumatoid arthritis patients from the University of Minnesota Rheumatology clinics.
Who may be able to join
- Diagnosis of rheumatoid arthritis
Who cannot join
- Use of rituximab immediately prior to visit
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Medicine
Minneapolis, Minnesota, 55455
About this study
This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA.
Read the detailed description
The investigators are interested in learning about the immune cells in the blood that contribute to disease in patients with rheumatoid arthritis (RA). They have developed a method for identifying a specific type of immune cells that can react against normal tissues in the body.
In this study, the investigators will enroll RA patients from the University of Minnesota clinics, collect blood samples from enrolled patients, and process the blood samples to isolate DNA, RNA, serum, and blood cells. They will use the serum to detect whether specific autoantibodies (Anti-cyclic Citrullinated Peptide, or anti-CCP) are present. In cases where anti-CCP antibodies are detected, the investigators may quantify the numbers of immune cells present that contain receptors with the same anti-CCP specificity. They may also test whether the numbers of immune cells with these receptors correlate with measures of disease activity in RA patients.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- No intervention (observational)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational)Other
No intervention (observational)
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Rheumatoid arthritis patients Receives: Other: No intervention (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-ESR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2011
- Primary completionSep 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 129 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Mueller, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813083
- Sponsor's protocol ID
- 20494
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2016
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pathological Lymphocytes in Patients With Autoimmune Disease
- ClinicalTrials.gov ID
- NCT02813083
- Acronym / sponsor ID
- 20494
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 24 Jun 2016 (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.
This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA.
Detailed description
The investigators are interested in learning about the immune cells in the blood that contribute to disease in patients with rheumatoid arthritis (RA). They have developed a method for identifying a specific type of immune cells that can react against normal tissues in the body.
In this study, the investigators will enroll RA patients from the University of Minnesota clinics, collect blood samples from enrolled patients, and process the blood samples to isolate DNA, RNA, serum, and blood cells. They will use the serum to detect whether specific autoantibodies (Anti-cyclic Citrullinated Peptide, or anti-CCP) are present. In cases where anti-CCP antibodies are detected, the investigators may quantify the numbers of immune cells present that contain receptors with the same anti-CCP specificity. They may also test whether the numbers of immune cells with these receptors correlate with measures of disease activity in RA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: No intervention (observational)Rheumatoid arthritis patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will enroll 155 rheumatoid arthritis patients from the University of Minnesota Rheumatology clinics.
Key inclusion criteria (1 listed)
- Diagnosis of rheumatoid arthritis
Key exclusion criteria (2 listed)
- Use of rituximab immediately prior to visit
- Pregnancy
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 |
|---|---|---|
| No intervention (observational)No intervention (observational) | Other | Rheumatoid Arthritis |
Primary outcome
DAS28-ESR
Time frame: 6 months
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 5 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Arthritis, Rheumatoid
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.
Daniel Mueller, M.D. principal investigator
University of Minnesota
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 Arthritis, Rheumatoid, run by University of Minnesota 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 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: finished, as of the sponsor's last update on 5 Apr 2024. 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.
What does the primary outcome measure?
DAS28-ESR (time frame: 6 months). 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 5 Apr 2024.