Rheumatoid ArthritisPhase 3SYBRANCT05379322
The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
A Phase 3 study testing Anti-TNF and JAK inhibitor in people with Rheumatoid Arthritis, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
Trial summary
SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. 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?
- Anti-TNF and JAK inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Mar 2023to 1 Mar 2023
- Phase
- Phase 3
- 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
- Subject should be capable of consent
- Age 18 and older
- Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
- Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
- Can be on steroid dose <7.5mg
- Quantiferon negative
- Hepatitis B, C negative
- No recent history (<5y) of malignancy
Who cannot join
- Overlap syndrome
- Previously treated with a biological medication
- Heart failure NYHA III/IV
- Active tuberculosis
- Active infections
- Previous history of DVT, PE, or Stroke
- Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis 2020.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Abu Dhabi Stem Cells Center
Abu Dhabi, Abu Dhabi Emirate, 4600
About this study
SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Anti-TNF, JAK inhibitor
- Keywords
- Rheumatoid Arthritis, Synovial biopsy, Biologic therapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNFDrug
Also called Adalimumab, etanercept, certolizumab, or golimumab
Upon analysis of the sample, patients that are falling into specific phenotypes (diffuse myeloid or pauci-cellular phenotypes) will be assigned to receive anti-TNF as biologic DMARD medications.
JAK inhibitorDrug
Also called Tofacitinib, baricitinib, or upadacitinib
Upon analysis of the sample, patients that are falling into specific phenotypes (lymphoid- myeloid or pauci-cellular phenotypes) will be assigned to receive JAK inhibitors as biologic DMARD medications.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Anti-TNF) | Experimental | Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the diffuse myeloid phenotype will be assigned to receive anti-TNF medication at the discretion of the treating physician. Receives: Drug: Anti-TNF |
| Group B (JAK inhibitor) | Experimental | Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the lymphoid- myeloid phenotype will be assigned to receive JAK inhibitor medication at the discretion of the treating physician. Receives: Drug: JAK inhibitor |
| Group C (Anti-TNF or JAK inhibitor) | Experimental | Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the pauci-cellular phenotype will be randomized to either anti-TNF or JAK inhibitor medication 1:1. Receives: Drug: Anti-TNF; Drug: JAK inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DAS28 score
Change in DAS28 score indicating remission compared to baseline in at least 50% of patients, where DS28<2.6 indicated remission.
- DAS score: disease activity score, where <2.6 indicates remission, 2.6-3.2 low disease activity. 3.2-5.1 moderate disease activity; >5.1 high disease activity; higher values suggest worse outcomes.
Measured: Baseline, Visit 3 (12 weeks)
Secondary outcomes (3)
Change in HAQ score
Significant decrease in HAQ score compared to baseline.
- HAQ (Health assessment questionnaire). Scores vary from 0-to 3. Higher scores are associated with worse outcomes.
Measured: Baseline, Visit 3 (12 weeks)
Change in power Doppler activity
Change in power Doppler activity compared to a baseline where no power Doppler activity indicates remission. Measurement in Doppler activity on ultrasound using a grading system developed by EULAR.
- Global EULAR-OMERACT Synovitis Score: scores range from 0-3 for each scanned joint. Higher scores correlate with worse outcomes.
Measured: Baseline, Visit 3 (12 weeks)
Change in cellular phenotype
Change in cellular phenotype compared to baseline. Estimation of change in the number of inflammatory cells as per the grading criteria.
Measured: Baseline, Visit 3 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Mar 2023
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Decision of the local healthcare authority
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Stem Cells Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gianina Statache, MD, Principal investigator, Abu Dhabi Stem Cells CenterRene A. Rivero Jimenez, PhD, Study chair, Abu Dhabi Stem Cells Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379322
- Sponsor's protocol ID
- CT.006.1.1.SYBRA
- Acronym
- SYBRA
- Status last verified
- Oct 2025
- First submitted
- 12 May 2022
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05379322
- Acronym / sponsor ID
- SYBRA / CT.006.1.1.SYBRA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Synovial biopsy, Biologic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision of the local healthcare authority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abu Dhabi Stem Cells CenterOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 18 May 2022 (actual)
- 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.
SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Anti-TNF) | Experimental | Drug: Anti-TNFRheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the diffuse myeloid phenotype will be assigned to receive anti-TNF medication at the discretion of the treating physician. |
| Group B (JAK inhibitor) | Experimental | Drug: JAK inhibitorRheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the lymphoid- myeloid phenotype will be assigned to receive JAK inhibitor medication at the discretion of the treating physician. |
| Group C (Anti-TNF or JAK inhibitor) | Experimental | Drug: Anti-TNF, Drug: JAK inhibitorRheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the pauci-cellular phenotype will be randomized to either anti-TNF or JAK inhibitor medication 1:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject should be capable of consent
- Age 18 and older
- Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
- Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
- Can be on steroid dose <7.5mg
Key exclusion criteria (8 listed)
- Overlap syndrome
- Previously treated with a biological medication
- Heart failure NYHA III/IV
- Active tuberculosis
- Active infections
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 |
|---|---|---|
| Anti-TNFAlso: Adalimumab, etanercept, certolizumab, or golimumabUpon analysis of the sample, patients that are falling into specific phenotypes (diffuse myeloid or pauci-cellular phenotypes) will be assigned to receive anti-TNF as biologic DMARD medications. | Drug | Group A (Anti-TNF), Group C (Anti-TNF or JAK inhibitor) |
| JAK inhibitorAlso: Tofacitinib, baricitinib, or upadacitinibUpon analysis of the sample, patients that are falling into specific phenotypes (lymphoid- myeloid or pauci-cellular phenotypes) will be assigned to receive JAK inhibitors as biologic DMARD medications. | Drug | Group B (JAK inhibitor), Group C (Anti-TNF or JAK inhibitor) |
Primary outcome
Change in DAS28 score
Time frame: Baseline, Visit 3 (12 weeks)
Change in DAS28 score indicating remission compared to baseline in at least 50% of patients, where DS28<2.6 indicated remission. * DAS score: disease activity score, where <2.6 indicates remission, 2.6-3.2 low disease activity. 3.2-5.1 moderate disease activity; >5.1 high disease activity; higher values suggest worse outcomes.
3 secondary outcomes
Change in HAQ score
Time frame: Baseline, Visit 3 (12 weeks)
Change in power Doppler activity
Time frame: Baseline, Visit 3 (12 weeks)
Change in cellular phenotype
Time frame: Baseline, Visit 3 (12 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Gianina Statache, MD principal investigator
Abu Dhabi Stem Cells Center
Rene A. Rivero Jimenez, PhD study chair
Abu Dhabi Stem Cells Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-TNF and JAK inhibitor in people with Rheumatoid Arthritis, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 6 Oct 2025. 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 Arab Emirates. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in DAS28 score (time frame: Baseline, Visit 3 (12 weeks)). 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 6 Oct 2025.