Stand UP to Rheumatoid Arthritis (SUPRA) (SUPRA)

January 30, 2026 updated by: Marie Hudson, MD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B. Davis Jewish General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sub-study 1 TNFi
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)
Drug: TNFi
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.
Other Names:
  • Etanercept
  • Adalimumab
  • Certolizumab
  • Golimumab
Active Comparator: Sub-study 1 Anti-IL6
Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab
Drug: Anti-IL6
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)
Other Names:
  • Sarilumab
  • Tocilizumab
Active Comparator: Sub-study 2 Anti-IL6
Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab
Drug: Anti-IL6
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)
Other Names:
  • Sarilumab
  • Tocilizumab
Active Comparator: Sub-study 2 JAKi
JAKi - tofacitinib (JAK1/3 inhibitor), baricitinib (JAK 1/2 inhibitor) or upadacitinib (JAK1 inhibitor)
Drug: JAKi
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)
Other Names:
  • Baricitinib
  • Upadacitinib
  • Tofacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recruitment at two RA referral centers over 12 months
Time Frame: 12 months
Feasibility outcome
12 months
Prompt access to drugs
Time Frame: 4 weeks
Feasibility outcome
4 weeks
Proportion of participants adhering to the allocated treatment
Time Frame: 24 months
Feasibility outcome
24 months
Proportion of eligible patients who are invited to participate by their physician
Time Frame: 12 months
Physician acceptability outcome
12 months
Proportion of eligible patients who accept to participate
Time Frame: 12 months
Patient acceptability outcome
12 months
Proportion of patients reaching SDAI <= 3.3
Time Frame: 24 months
Exploratory outcome
24 months
Proportion of patients reaching DAS28 LDA state
Time Frame: 24 months
Exploratory outcome
24 months
Patient-reported outcomes (function, health-related quality of life, fatigue)
Time Frame: 24 months
Exploratory outcome
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marie Hudson, MD

Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lady Davis Institute
Montreal General Hospital

Investigators

  • Principal Investigator: Marie Hudson, MD, Sir Mortimer B. Davis - Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-05-2022-3107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.).

IPD Sharing Time Frame

After 2025, for 3 years

IPD Sharing Access Criteria

The sharing of these samples will be done under specific research agreements; the samples and the data will be coded and confidentiality strictly protected.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on TNFi

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe