Recruiting

SUPRA

Sponsor:

Marie Hudson, MD

Code:

NCT05305066

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TNFi

Anti-IL6

JAKi

Study Details

Brief 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. This is what personalized medicine is all about.

Conditions

Rheumatoid Arthritis

Study ID

NCT05305066

Start date

Feb 1, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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)

active comparator: Sub-study 1 Anti-IL6

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

active comparator: Sub-study 2 Anti-IL6

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

active comparator: Sub-study 2 JAKi

JAKi - tofacitinib (JAK1/3 inhibitor), baricitinib (JAK 1/2 inhibitor) or upadacitinib (JAK1 inhibitor)

Interventions

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.

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)

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Marie Hudson, MD

514-340-8222marie.hudson@mcgill.ca

Locations

Sir Mortimer B. Davis Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Marie Hudson, MD MPH

1-514-340-8222marie.hudson@mcgill.ca

More Information

Sponsor

Marie Hudson, MD

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Rheumatoid arthritis
  • Pragmatic trials
  • Feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marie Hudson, MD on 2026-02-03.