Stand UP to Rheumatoid Arthritis (SUPRA)

NCT05305066 | Recruiting

• 1 other identifier: MP-05-2022-3107
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Rheumatoid arthritis; Pragmatic trials; Feasibility

Outcome Measures

Primary Outcomes (8)

• Rate of recruitment at two RA referral centers over 12 months

  Feasibility outcome

  12 months

• Prompt access to drugs

  Feasibility outcome

  4 weeks

• Proportion of participants adhering to the allocated treatment

  Feasibility outcome

  24 months

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

  Physician acceptability outcome

  12 months

• Proportion of eligible patients who accept to participate

  Patient acceptability outcome

  12 months

• Proportion of patients reaching SDAI <= 3.3

  Exploratory outcome

  24 months

• Proportion of patients reaching DAS28 LDA state

  Exploratory outcome

  24 months

• Patient-reported outcomes (function, health-related quality of life, fatigue)

  Exploratory outcome

  24 months

Study Arms (4)

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)

Drug: TNFi

Sub-study 1 Anti-IL6

ACTIVE COMPARATOR

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

Drug: Anti-IL6

Sub-study 2 Anti-IL6

ACTIVE COMPARATOR

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

Drug: Anti-IL6

Sub-study 2 JAKi

ACTIVE COMPARATOR

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

Drug: JAKi

Interventions

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.

Also known as: Etanercept, Adalimumab, Golimumab, Certolizumab

Sub-study 1 TNFi

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)

Also known as: Tocilizumab, Sarilumab

Sub-study 1 Anti-IL6; Sub-study 2 Anti-IL6

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)

Also known as: Tofacitinib, Upadacitinib, Baricitinib

Sub-study 2 JAKi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Marie Hudson, MD: lead
• Montreal General Hospital: collaborator
• Lady Davis Institute: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 25956159 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Adalimumab; golimumab; Certolizumab Pegol; Interleukin-6 Inhibitors; tocilizumab; sarilumab; tofacitinib; upadacitinib; baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marie Hudson, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Hudson, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Rheumatologist, Jewish General Hospital; Physician-scientist, Lady Davis Institute for Medical Research

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 31, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 2025, for 3 years
• 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.

Locations

CA (1)