Rheumatoid ArthritisBMUSNCT02476084
Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Musculoskeletal Ultrasound Imaging, Synovial biopsy and Biological samples collection
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2014to 1 Oct 2021
- 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: Rheumatoid Arthritis Patients
Who may be able to join
- Written confirmed diagnosis of Rheumatoid Arthritis as per ACR/EULAR 2010 criteria.
- If patient is on oral corticosteroids, dose must be stable for 6 weeks prior to baseline visit.
- Willingness and ability to comply with all the study procedures.
Who cannot join
- Any systemic inflammation conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. Examples include psoriatic arthritis, reactive arthritis, gout, systemic lupus erythematosus (SLE), polymyalgia rheumatic and/or temporal arteritis, Lyme's disease, fibromyalgia and chronic fatigue syndromes.
- Major surgery planned within 8 weeks prior to screening or planned surgery throughout the study period.
- Treatment with any investigational agent ≤ 4 weeks prior to baseline (or 5 ≤ half-lives of the investigational drug, whichever is the longer).
- Intramuscular/intra-articular glucocorticoids for 6 weeks prior to baseline visit.
- Active infection.
- Septic arthritis within a native joint within the last 12 months.
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- Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ.
- Known HIV or hepatitis B/C infection.
- Latent TB infection unless they have completed adequate antibiotic prophylaxis.
- Malignancy (other than basal cell carcinoma) within the last 10 years.
- New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure.
- Demyelinating disease.
- Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
- Known recent substance abuse (drug or alcohol).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients: a Pilot Observational Study
The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Musculoskeletal Ultrasound Imaging, Synovial biopsy, Biological samples collection, Questionnaires
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal Ultrasound ImagingOther
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Synovial biopsyOther
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Biological samples collectionOther
Draw of research blood samples.
QuestionnairesOther
Administration of validated patients' questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Conventional synthetic DMARD naïve | Naive RA patients commencing Methotrexate and Hydroxychloroquine.
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. Receives: Other: Musculoskeletal Ultrasound Imaging; Other: Synovial biopsy; Other: Biological samples collection; Other: Questionnaires | |
| DMARD-IR: anti-TNF | Conventional synthetic DMARD inadequate responders commencing Anti-TNF
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. Receives: Other: Musculoskeletal Ultrasound Imaging; Other: Synovial biopsy; Other: Biological samples collection; Other: Questionnaires | |
| DMARD-IR: anti-IL6 | Conventional synthetic DMARD inadequate responders commencing anti-IL6
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. Receives: Other: Musculoskeletal Ultrasound Imaging; Other: Synovial biopsy; Other: Biological samples collection; Other: Questionnaires | |
| DMARD-IR: anti-CTLA-4 | Conventional synthetic DMARD inadequate responders commencing anti-CTLA-4
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. Receives: Other: Musculoskeletal Ultrasound Imaging; Other: Synovial biopsy; Other: Biological samples collection; Other: Questionnaires | |
| DMARD-IR: anti-CD20 | Conventional synthetic DMARD inadequate responders commencing anti-CD20
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. Receives: Other: Musculoskeletal Ultrasound Imaging; Other: Synovial biopsy; Other: Biological samples collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.
Measured: 3 years
Secondary outcomes (3)
Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.
Measured: 3 years
Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.
Measured: 3 years
Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start13 Oct 2014
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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 OxfordThe 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-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Peter C Taylor, PhD, FRCP, Principal investigator, Kennedy Institute of Rheumatology, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476084
- Sponsor's protocol ID
- 149600
- Acronym
- BMUS
- Status last verified
- Oct 2020
- First submitted
- 19 May 2015
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients: a Pilot Observational Study
- ClinicalTrials.gov ID
- NCT02476084
- Acronym / sponsor ID
- BMUS / 149600
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 19 Jun 2015 (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 the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Conventional synthetic DMARD naïve | – | Other: Musculoskeletal Ultrasound Imaging, Other: Synovial biopsy, Other: Biological samples collection, Other: QuestionnairesNaive RA patients commencing Methotrexate and Hydroxychloroquine. Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| DMARD-IR: anti-TNF | – | Other: Musculoskeletal Ultrasound Imaging, Other: Synovial biopsy, Other: Biological samples collection, Other: QuestionnairesConventional synthetic DMARD inadequate responders commencing Anti-TNF Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| DMARD-IR: anti-IL6 | – | Other: Musculoskeletal Ultrasound Imaging, Other: Synovial biopsy, Other: Biological samples collection, Other: QuestionnairesConventional synthetic DMARD inadequate responders commencing anti-IL6 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| DMARD-IR: anti-CTLA-4 | – | Other: Musculoskeletal Ultrasound Imaging, Other: Synovial biopsy, Other: Biological samples collection, Other: QuestionnairesConventional synthetic DMARD inadequate responders commencing anti-CTLA-4 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| DMARD-IR: anti-CD20 | – | Other: Musculoskeletal Ultrasound Imaging, Other: Synovial biopsy, Other: Biological samples collection, Other: QuestionnairesConventional synthetic DMARD inadequate responders commencing anti-CD20 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis Patients
Key inclusion criteria (3 listed)
- Written confirmed diagnosis of Rheumatoid Arthritis as per ACR/EULAR 2010 criteria.
- If patient is on oral corticosteroids, dose must be stable for 6 weeks prior to baseline visit.
- Willingness and ability to comply with all the study procedures.
Key exclusion criteria (14 listed)
- Any systemic inflammation conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. Examples include psoriatic arthritis, reactive arthritis, gout, systemic lupus erythematosus (SLE), polymyalgia rheumatic and/or temporal arteritis, Lyme's disease, fibromyalgia and chronic fatigue syndromes.
- Major surgery planned within 8 weeks prior to screening or planned surgery throughout the study period.
- Treatment with any investigational agent ≤ 4 weeks prior to baseline (or 5 ≤ half-lives of the investigational drug, whichever is the longer).
- Intramuscular/intra-articular glucocorticoids for 6 weeks prior to baseline visit.
- Active infection.
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 |
|---|---|---|
| Musculoskeletal Ultrasound ImagingB-mode and PD musculoskeletal ultrasound examination of selected joints. | Other | Conventional synthetic DMARD naïve, DMARD-IR: anti-CD20, DMARD-IR: anti-CTLA-4, DMARD-IR: anti-IL6, DMARD-IR: anti-TNF |
| Synovial biopsyUS guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees. | Other | Conventional synthetic DMARD naïve, DMARD-IR: anti-CD20, DMARD-IR: anti-CTLA-4, DMARD-IR: anti-IL6, DMARD-IR: anti-TNF |
| Biological samples collectionDraw of research blood samples. | Other | Conventional synthetic DMARD naïve, DMARD-IR: anti-CD20, DMARD-IR: anti-CTLA-4, DMARD-IR: anti-IL6, DMARD-IR: anti-TNF |
| QuestionnairesAdministration of validated patients' questionnaires. | Other | Conventional synthetic DMARD naïve, DMARD-IR: anti-CD20, DMARD-IR: anti-CTLA-4, DMARD-IR: anti-IL6, DMARD-IR: anti-TNF |
Primary outcome
Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.
Time frame: 3 years
3 secondary outcomes
Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.
Time frame: 3 years
Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.
Time frame: 3 years
Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.
Time frame: 3 years
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 May 2022.
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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.
Peter C Taylor, PhD, FRCP principal investigator
Kennedy Institute of Rheumatology, University of Oxford
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, run by University of Oxford at 1 site in United Kingdom.
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 14 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 May 2022. 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 Kingdom. 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?
Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis. (time frame: 3 years). 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 May 2022.