Health TrialsbyHealthPanel

Stand UP to Rheumatoid Arthritis (SUPRA)

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarie Hudson, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • TNFi

    Drug

    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

    Drug

    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

    Drug

    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)

Treatment groups

75 Participants
are divided into 4 treatment groups
Group A: Sub-study 1 TNFiActive comparator 1 intervention
Group B: Sub-study 1 Anti-IL6Active comparator 1 intervention
Group C: Sub-study 2 Anti-IL6Active comparator 1 intervention
Group D: Sub-study 2 JAKiActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of recruitment at two RA referral centers over 12 months

Feasibility outcome

Time frame
12 months
2

Prompt access to drugs

Feasibility outcome

Time frame
4 weeks
3

Proportion of participants adhering to the allocated treatment

Feasibility outcome

Time frame
24 months
4

Proportion of eligible patients who are invited to participate by their physician

Physician acceptability outcome

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marie Hudson, MD

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Sponsor institution

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Montreal General Hospital

Collaborator

Lady Davis Institute

Collaborator

Source ClinicalTrials.gov
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