Rheumatoid ArthritisSUPRANCT05305066
Stand UP to Rheumatoid Arthritis (SUPRA)
A study testing TNFi, Anti-IL6 and JAKi in people with Rheumatoid Arthritis, run by Marie Hudson, MD at 1 site in Canada.
Trial summary
Rheumatoid arthritis is a disabling arthritis that affects young women disproportionately. Although the physicians have some excellent treatments, they do not know which treatment is best for which patient. The investigators want to find ways to identify the right drug for the right patient at the right time. 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?
- TNFi, Anti-IL6 and JAKi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years;
- Arthritis that fulfills the 2010 ACR/EULAR classification criteria for RA;
- Failure to standard conventional synthetic DMARDs and eligible for second-line b/tsDMARDs (Sub-study 1) or failure to at least one TNF inhibitor and eligible for third-line b/tsDMARDs (Sub-study 2).
Who cannot join
- Prior b/tsDMARDs for Sub-study 1 or prior b/tsDMARDs other than TNF inhibitors for Sub-study 2;
- Contraindication to b/tsDMARD therapy, such as active infection or untreated latent TB, current malignancy, severe organ dysfunction, history of VTE (unless anticoagulated), high risk of cardiovascular disease, pregnancy/lactation;
- Overlap with another inflammatory disease requiring specific immunosuppressive therapy, such as lupus nephritis;
- Unable to provide consent or complete forms (alone or with assistance) in English or French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Marie Hudson, MD MPH, 1-514-340-8222 ext. 23476, marie.hudson@mcgill.ca
About this study
Official title: Innovative Trial Designs, Multi-omics and Advanced Computational Prediction to Transform Clinical Care in RA
Rheumatoid arthritis is a disabling arthritis that affects young women disproportionately. Although the physicians have some excellent treatments, they do not know which treatment is best for which patient. The investigators want to find ways to identify the right drug for the right patient at the right time. This is what personalized medicine is all about.
Read the detailed description
Rheumatoid arthritis (RA) is a complex, chronic disease of the immune system characterized by disfiguring and disabling arthritis. It affects predominantly women (3:1 ratio with men) and has its peak onset during their most productive years (ages 30-50). RA is associated with serious morbidity (including impaired fertility and pregnancy outcomes, disability, and depression) and premature mortality (particularly from cardiovascular and infectious causes). The Arthritis Alliance of Canada estimates that the cost of RA will exceed $30 billion in Canada in 2040.
First-line treatment of RA consists of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) with methotrexate considered as the gold standard. Yet, only 30% of patients will achieve adequate response to methotrexate and the majority will need additional treatment. The development of new biologic and targeted synthetic DMARDs (b/tsDMARDs) in the 20th century has transformed the treatment of RA. Anti-tumour necrosis factor (TNF)-α molecules were the first clinically successful biologic therapies for RA. Drugs targeting other signaling pathways (JAK-STAT, which work downstream of interferons), inflammatory cytokines (IL-6), as well as B cells and T cells have now also become available. Molecules with novel targets (eg. GM-CSF, CD40L) are in clinical trials.
Although hailed as 'game-changers' in patient care, the inconvenient truth is that even though nine different b/tsDMARDs are currently available to treat RA, 30% of patients will fail any particular drug. Moreover, physicians have no reliable way of predicting response and guiding treatment decisions. Clinical and genetic predictors have been the subject of intense research but these factors explain only a small portion of the observed variance in treatment response. Using the current trial-and-error approach, patients can cycle through multiple drugs before finally attaining disease control. This means months or years of suboptimal disease control and considerable losses in many domains including physical and emotional well-being, family and social networks, and occupational attainment. The lack of a personalized approach is particularly detrimental in RA because there is a narrow ''window of opportunity'' in the first 3-6 months of onset to control disease and optimize long term outcomes. In addition, failure to personalize treatment may also result in wasted spending on ineffective drugs, that cost up to $20,000 per patient per year, and exposing patients to unnecessary risks of adverse events, in particular serious infections.
There is a critical need to 1) transform the current 'trial-and-error' treatment paradigm, 2) explore novel predictors of b/tsDMARD response in RA and, 3) harness the power of advanced analytical strategies to personalize treatment decision-making and optimize outcomes in RA. The investigators propose a multi-pronged solution that combines innovative trial designs, multi-omics and advanced computational prediction to transform clinical care in RA.
The investigators propose to develop a new model of care and investigate new avenues, including sex and gender, diet, gut bacteria and environmental exposures, to make treatment decisions. The investigators will also use new methods of analyzing complex information. The highly talented research team has what is needed to transform the care of people living with RA.
In preparation for a full-scale study, the investigators propose this feasibility study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TNFi, Anti-IL6, JAKi
- Keywords
- Rheumatoid arthritis, Pragmatic trials, Feasibility
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFiDrug
Also called Etanercept, Adalimumab, Golimumab, Certolizumab
TNFi - any sub-cutaneous (sc) formulation, namely etanercept (receptor fusion protein) 50 mg sc per week, adalimumab (monoclonal antibody) 40 mg sc every 2 weeks, golimumab (monoclonal antibody) 50 mg sc every month, or certolizumab (pegylated fragment of a monoclonal antibody) 400 mg sc at week 0, 2 and 4, and then 200 mg sc every 2 weeks or 400 mg sc every 4 weeks.
Anti-IL6Drug
Also called Tocilizumab, Sarilumab
Anti-IL6 receptor monoclonal antibodies - tocilizumab (if weight <100 kg: 162 mg SC every other week, followed by an increase to weekly based on clinical response; if weight ≥100 kg: 162 mg SC weekly) or sarilumab (200 mg SC once every 2 weeks)
JAKiDrug
Also called Tofacitinib, Upadacitinib, Baricitinib
JAKi - tofacitinib (JAK1/3 inhibitor) 5 mg po bid, baricitinib 2 mg po qd (JAK 1/2 inhibitor) or upadacitinib 15 mg po qd (JAK1 inhibitor)
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1 TNFi | Active comparator | TNFi - any sub-cutaneous (sc) formulation, namely etanercept (receptor fusion protein), adalimumab (monoclonal antibody), golimumab (monoclonal antibody), or certolizumab (pegylated fragment of a monoclonal antibody) Receives: Drug: TNFi |
| Sub-study 1 Anti-IL6 | Active comparator | Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab Receives: Drug: Anti-IL6 |
| Sub-study 2 Anti-IL6 | Active comparator | Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab Receives: Drug: Anti-IL6 |
| Sub-study 2 JAKi | Active comparator | JAKi - tofacitinib (JAK1/3 inhibitor), baricitinib (JAK 1/2 inhibitor) or upadacitinib (JAK1 inhibitor) Receives: Drug: JAKi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment at two RA referral centers over 12 months
Feasibility outcome
Measured: 12 months
Prompt access to drugs
Feasibility outcome
Measured: 4 weeks
Proportion of participants adhering to the allocated treatment
Feasibility outcome
Measured: 24 months
Proportion of eligible patients who are invited to participate by their physician
Physician acceptability outcome
Measured: 12 months
Proportion of eligible patients who accept to participate
Patient acceptability outcome
Measured: 12 months
Proportion of patients reaching SDAI <= 3.3
Exploratory outcome
Measured: 24 months
Proportion of patients reaching DAS28 LDA state
Exploratory outcome
Measured: 24 months
Patient-reported outcomes (function, health-related quality of life, fatigue)
Exploratory outcome
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Feb 2023
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two separate sub-studies will be conducted: Sub-study 1: Subjects who have failed conventional DMARDS will be randomised to receive therapy with TNFi or anti-IL6 using covariate adaptive randomization. Sub-study 2: Subjects who have failed TNFi will be randomised to receive therapy with anti-IL6 or JAKi using covariate adaptive randomization.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marie Hudson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Montreal General Hospital, Lady Davis Institute
- Responsible party
- Sponsor-investigator, Marie Hudson, MD, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Marie Hudson, MD, Principal investigator, Sir Mortimer B. Davis - Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305066
- Sponsor's protocol ID
- MP-05-2022-3107
- Acronym
- SUPRA
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' study information and biological samples may be shared with researchers at this institution or other institutions for genetic, immunological, and other analyses (e.g. microbiome sequencing, biomarkers analyses, etc.).
Publications
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
PubMed 25956159
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Trial Designs, Multi-omics and Advanced Computational Prediction to Transform Clinical Care in RA
- ClinicalTrials.gov ID
- NCT05305066
- Acronym / sponsor ID
- SUPRA / MP-05-2022-3107
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Pragmatic trials, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Marie Hudson, MDUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Montreal General Hospital, Lady Davis Institute
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 31 Mar 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.
Rheumatoid arthritis is a disabling arthritis that affects young women disproportionately. Although the physicians have some excellent treatments, they do not know which treatment is best for which patient. The investigators want to find ways to identify the right drug for the right patient at the right time. This is what personalized medicine is all about.
Detailed description
Rheumatoid arthritis (RA) is a complex, chronic disease of the immune system characterized by disfiguring and disabling arthritis. It affects predominantly women (3:1 ratio with men) and has its peak onset during their most productive years (ages 30-50). RA is associated with serious morbidity (including impaired fertility and pregnancy outcomes, disability, and depression) and premature mortality (particularly from cardiovascular and infectious causes). The Arthritis Alliance of Canada estimates that the cost of RA will exceed $30 billion in Canada in 2040.
First-line treatment of RA consists of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) with methotrexate considered as the gold standard. Yet, only 30% of patients will achieve adequate response to methotrexate and the majority will need additional treatment. The development of new biologic and targeted synthetic DMARDs (b/tsDMARDs) in the 20th century has transformed the treatment of RA. Anti-tumour necrosis factor (TNF)-α molecules were the first clinically successful biologic therapies for RA. Drugs targeting other signaling pathways (JAK-STAT, which work downstream of interferons), inflammatory cytokines (IL-6), as well as B cells and T cells have now also become available. Molecules with novel targets (eg. GM-CSF, CD40L) are in clinical trials.
Although hailed as 'game-changers' in patient care, the inconvenient truth is that even though nine different b/tsDMARDs are currently available to treat RA, 30% of patients will fail any particular drug. Moreover, physicians have no reliable way of predicting response and guiding treatment decisions. Clinical and genetic predictors have been the subject of intense research but these factors explain only a small portion of the observed variance in treatment response. Using the current trial-and-error approach, patients can cycle through multiple drugs before finally attaining disease control. This means months or years of suboptimal disease control and considerable losses in many domains including physical and emotional well-being, family and social networks, and occupational attainment. The lack of a personalized approach is particularly detrimental in RA because there is a narrow ''window of opportunity'' in the first 3-6 months of onset to control disease and optimize long term outcomes. In addition, failure to personalize treatment may also result in wasted spending on ineffective drugs, that cost up to $20,000 per patient per year, and exposing patients to unnecessary risks of adverse events, in particular serious infections.
There is a critical need to 1) transform the current 'trial-and-error' treatment paradigm, 2) explore novel predictors of b/tsDMARD response in RA and, 3) harness the power of advanced analytical strategies to personalize treatment decision-making and optimize outcomes in RA. The investigators propose a multi-pronged solution that combines innovative trial designs, multi-omics and advanced computational prediction to transform clinical care in RA.
The investigators propose to develop a new model of care and investigate new avenues, including sex and gender, diet, gut bacteria and environmental exposures, to make treatment decisions. The investigators will also use new methods of analyzing complex information. The highly talented research team has what is needed to transform the care of people living with RA.
In preparation for a full-scale study, the investigators propose this feasibility study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two separate sub-studies will be conducted: Sub-study 1: Subjects who have failed conventional DMARDS will be randomised to receive therapy with TNFi or anti-IL6 using covariate adaptive randomization. Sub-study 2: Subjects who have failed TNFi will be randomised to receive therapy with anti-IL6 or JAKi using covariate adaptive randomization.
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1 TNFi | Active comparator | Drug: TNFiTNFi - any sub-cutaneous (sc) formulation, namely etanercept (receptor fusion protein), adalimumab (monoclonal antibody), golimumab (monoclonal antibody), or certolizumab (pegylated fragment of a monoclonal antibody) |
| Sub-study 1 Anti-IL6 | Active comparator | Drug: Anti-IL6Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab |
| Sub-study 2 Anti-IL6 | Active comparator | Drug: Anti-IL6Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab |
| Sub-study 2 JAKi | Active comparator | Drug: JAKiJAKi - tofacitinib (JAK1/3 inhibitor), baricitinib (JAK 1/2 inhibitor) or upadacitinib (JAK1 inhibitor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Arthritis that fulfills the 2010 ACR/EULAR classification criteria for RA;
- Failure to standard conventional synthetic DMARDs and eligible for second-line b/tsDMARDs (Sub-study 1) or failure to at least one TNF inhibitor and eligible for third-line b/tsDMARDs (Sub-study 2).
Key exclusion criteria (4 listed)
- Prior b/tsDMARDs for Sub-study 1 or prior b/tsDMARDs other than TNF inhibitors for Sub-study 2;
- Contraindication to b/tsDMARD therapy, such as active infection or untreated latent TB, current malignancy, severe organ dysfunction, history of VTE (unless anticoagulated), high risk of cardiovascular disease, pregnancy/lactation;
- Overlap with another inflammatory disease requiring specific immunosuppressive therapy, such as lupus nephritis;
- Unable to provide consent or complete forms (alone or with assistance) in English or French
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 |
|---|---|---|
| TNFiAlso: Etanercept, Adalimumab, Golimumab, CertolizumabTNFi - any sub-cutaneous (sc) formulation, namely etanercept (receptor fusion protein) 50 mg sc per week, adalimumab (monoclonal antibody) 40 mg sc every 2 weeks, golimumab (monoclonal antibody) 50 mg sc every month, or certolizumab (pegylated fragment of a monoclonal antibody) 400 mg sc at week 0, 2 and 4, and then 200 mg sc every 2 weeks or 400 mg sc every 4 weeks. | Drug | Sub-study 1 TNFi |
| Anti-IL6Also: Tocilizumab, SarilumabAnti-IL6 receptor monoclonal antibodies - tocilizumab (if weight <100 kg: 162 mg SC every other week, followed by an increase to weekly based on clinical response; if weight ≥100 kg: 162 mg SC weekly) or sarilumab (200 mg SC once every 2 weeks) | Drug | Sub-study 1 Anti-IL6, Sub-study 2 Anti-IL6 |
| JAKiAlso: Tofacitinib, Upadacitinib, BaricitinibJAKi - tofacitinib (JAK1/3 inhibitor) 5 mg po bid, baricitinib 2 mg po qd (JAK 1/2 inhibitor) or upadacitinib 15 mg po qd (JAK1 inhibitor) | Drug | Sub-study 2 JAKi |
Primary outcome
Rate of recruitment at two RA referral centers over 12 months
Time frame: 12 months
Feasibility outcome
Prompt access to drugs
Time frame: 4 weeks
Feasibility outcome
Proportion of participants adhering to the allocated treatment
Time frame: 24 months
Feasibility outcome
Proportion of eligible patients who are invited to participate by their physician
Time frame: 12 months
Physician acceptability outcome
Proportion of eligible patients who accept to participate
Time frame: 12 months
Patient acceptability outcome
Proportion of patients reaching SDAI <= 3.3
Time frame: 24 months
Exploratory outcome
Proportion of patients reaching DAS28 LDA state
Time frame: 24 months
Exploratory outcome
Patient-reported outcomes (function, health-related quality of life, fatigue)
Time frame: 24 months
Exploratory outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 25956159Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
- Individual participant dataSharing planned: Yes. Participants' study information and biological samples may be shared with researchers at this institution or other institutions for genetic, immunological, and other analyses (e.g. microbiome sequencing, biomarkers analyses, etc.).
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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.
Marie Hudson, MD principal investigator
Sir Mortimer B. Davis - Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNFi, Anti-IL6 and JAKi in people with Rheumatoid Arthritis, run by Marie Hudson, MD at 1 site in Canada.
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 4 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Hudson, MD (514-340-8222 ext. 23476, marie.hudson@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment at two RA referral centers over 12 months (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305066, which also lists 1 linked publication.
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 3 Feb 2026.