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Interleukin-6 Inhibitor

Personalized Arthritis Medication for Rheumatoid Arthritis (SUPRA Trial)

N/A

Recruiting

Research Sponsored by Marie Hudson, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Arthritis that fulfills the 2010 ACR/EULAR classification criteria for RA

Age ≥ 18 years

Must not have

Overlap with another inflammatory disease requiring specific immunosuppressive therapy, such as lupus nephritis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trialaims to develop personalized treatments for rheumatoid arthritis, so that the right drug is given to the right patient at the right time. #PersonalizedMedicine

Who is the study for?

The SUPRA trial is for adults over 18 with Rheumatoid Arthritis who haven't improved after standard treatments. It's split into two parts: one for those needing a second-line treatment, and another for those where TNF inhibitors didn't work. Participants must be able to consent and fill out forms in English or French.

What is being tested?

This study tests different drugs (TNFi, JAKi, Anti-IL6) to find the best personalized treatment for Rheumatoid Arthritis patients. The goal is to match the right drug to each patient based on their specific needs at the correct time.

What are the potential side effects?

Potential side effects of these arthritis medications may include increased risk of infections, possible liver issues, changes in blood counts, and reactions at injection sites. Each medication has its own set of possible side effects that can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with rheumatoid arthritis according to the 2010 criteria.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another inflammatory condition like lupus that needs specific treatment.

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I cannot take certain arthritis medications due to an active infection, current cancer, severe organ issues, history of blood clots (unless I'm on blood thinners), high risk of heart disease, or because I am pregnant/breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Prompt access to drugs

Proportion of eligible patients who accept to participate

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Active Control

Group I: Sub-study 1 TNFiActive Control1 Intervention

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)

Group II: Sub-study 2 JAKiActive Control1 Intervention

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

Group III: Sub-study 1 Anti-IL6Active Control1 Intervention

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

Group IV: Sub-study 2 Anti-IL6Active Control1 Intervention

Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab

0 / 4Eligibility criteria met