What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis, such as non-TNFi biologics and targeted synthetic DMARDs (tsDMARDs), have various side effects. CD20 inhibitors like rituximab can cause infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy (PML). T-cell modulators like abatacept may lead to increased risk of infections and infusion-related reactions. IL-6 receptor inhibitors like tocilizumab are associated with elevated liver enzymes, lipid abnormalities, and increased risk of infections. JAK inhibitors, including tofacitinib, baricitinib, and upadacitinib, can cause infections, blood clots, and elevated liver enzymes. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several non-TNFi biologics and targeted synthetic DMARDs (tsDMARDs) for the treatment of Rheumatoid Arthritis (RA). Non-TNFi biologics include rituximab (CD20 inhibition), abatacept (T-cell modulation), and tocilizumab and sarilumab (IL-6 receptor inhibition). Additionally, tsDMARDs such as tofacitinib, baricitinib, and upadacitinib, which are Janus kinase (JAK) inhibitors, have also been approved. These treatments are particularly used for patients with active RA who do not respond adequately to TNFi biologics.

What other types of research exist?

Promising novel alternatives for RA treatment in 2024 include IL-23 inhibitors (e.g., risankizumab), IL-17 inhibitors (e.g., secukinumab), and new JAK inhibitors (e.g., filgotinib). These therapies target different pathways involved in the inflammatory process of RA and have shown efficacy in recent clinical trials.

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non-TNFi-biologic

Non-TNFi Biologics vs Targeted Synthetic DMARDs for Rheumatoid Arthritis (RA-PROPR Trial)

Phase 3

Recruiting

Led By Jasvinder Singh, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Latent TB for which anti-tubercular treatment has not been started

Untreated Hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing advanced medications for RA patients who haven't responded to standard treatments. It compares biologic drugs that target immune proteins and synthetic drugs that block harmful molecules in immune cells. The goal is to see which treatment improves patients' quality of life and daily functioning better. Biologic therapies have notably improved the treatment of RA, making disease remission a realistic goal.

Who is the study for?

This trial is for patients with active, disabling rheumatoid arthritis who have not improved after using a TNFi-biologic for at least 3 months or stopped due to side effects. They must be on stable doses of certain other medications if used and have access to the study drugs through insurance or assistance programs. People with recent steroid injections, sensitivity to all drug options in the trial, certain infections, untreated hepatitis B/C, pregnant/nursing women, HIV history, multiple prior biologics use or specific heart conditions cannot join.

What is being tested?

The RA-PRO PRAGMATIC TRIAL is testing whether switching to a non-TNFi biologic (like rituximab) or a targeted synthetic DMARD (like tofacitinib) is more effective for those whose rheumatoid arthritis remains active despite previous treatment with TNFi-biologics. The study aims to provide solid evidence on which option might work better by comparing patient outcomes.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased risk of infections. Specific side effects depend on the medication given but may involve digestive issues, liver function changes, blood disorders and possible allergic reactions.

Eligibility Criteria

Exclusion Criteria

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

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I have latent TB and haven't started treatment.

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I have Hepatitis B or C that has not been treated.

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I haven't had serious infections or been on strong antibiotics in the last month.

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I have a history of HIV or an opportunistic infection.

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I have been treated with more than three biologic drugs.

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I have been treated with synthetic drugs for my condition.

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I have severe heart failure.

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I have had a deep vein clot or lung clot before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 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

Functional Limitation

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: targeted synthetic DMARD classActive Control1 Intervention

Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment

Group II: non-TNFi-biologic classActive Control1 Intervention

Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite current treatment,

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) include non-TNFi biologics and targeted synthetic DMARDs (tsDMARDs). Non-TNFi biologics, such as CD20 inhibitors (rituximab), T-cell modulators (abatacept), and IL-6 receptor inhibitors (tocilizumab), work by targeting specific components of the immune system to reduce inflammation and prevent joint damage. CD20 inhibitors reduce B cells, T-cell modulators prevent T-cell activation, and IL-6 inhibitors block the inflammatory cytokine IL-6. tsDMARDs, like JAK inhibitors (tofacitinib, baricitinib), block enzymes called Janus kinases that are involved in the inflammatory process. These treatments are important for RA patients as they help manage symptoms, slow disease progression, and improve overall quality of life.