What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis, such as TNF inhibitors including adalimumab, etanercept, and infliximab, are generally effective but can have several side effects. These may include injection site reactions, increased risk of infections, and the development of anti-drug antibodies which can reduce the efficacy of the treatment. Other potential side effects include headaches, rash, and gastrointestinal issues. Serious adverse events, though less common, can include severe infections, liver toxicity, and bone marrow suppression. Regular monitoring and proactive therapeutic drug monitoring (TDM) can help manage and mitigate some of these risks.

What prior FDA approvals exist?

The FDA has approved several biologic DMARDs for the treatment of Rheumatoid Arthritis, particularly those targeting tumor necrosis factor (TNF). These include adalimumab (Humira), infliximab (Remicade), etanercept (Enbrel), certolizumab pegol (Cimzia), and golimumab (Simponi). These agents work by inhibiting TNF, a cytokine involved in systemic inflammation. The Proactive Therapeutic Drug Monitoring (TDM) study focuses on optimizing adalimumab dosing based on serum drug levels and anti-drug antibodies to maximize therapeutic efficacy and minimize adverse effects. This approach aims to personalize treatment and improve outcomes for RA patients.

What other types of research exist?

Promising novel alternatives to Proactive Therapeutic Drug Monitoring (TDM) for Rheumatoid Arthritis patients in 2024 include: 1) Janus kinase (JAK) inhibitors such as tofacitinib, baricitinib, and upadacitinib, which offer oral administration and have shown efficacy in RA management. 2) Biologic DMARDs with different mechanisms of action, such as IL-6 inhibitors (e.g., tocilizumab) and B-cell depleting agents (e.g., rituximab). 3) Combination therapies that utilize multiple DMARDs to achieve better disease control. 4) Personalized medicine approaches that use genetic and biomarker profiling to tailor treatments to individual patient profiles.

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Monoclonal Antibodies

Therapeutic Drug Monitoring for Rheumatoid Arthritis (TDM-RA Trial)

N/A

Waitlist Available

Led By Amanuel Kehasse, PharmD, PhD

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if monitoring and adjusting the levels of the drug adalimumab in the blood helps patients with rheumatoid arthritis achieve better treatment outcomes compared to standard care. Adalimumab is a therapeutic option for patients with moderate to severe rheumatoid arthritis.

Who is the study for?

This trial is for people with rheumatoid arthritis who are starting or already on standard adalimumab therapy, taking it every two weeks and have a good track record of taking their medication. It's not for those who've been on steroids long-term, have poor medication adherence, are pregnant or breastfeeding, have detectable anti-adalimumab antibodies, other immune diseases, or a history of infections affecting treatment.

What is being tested?

The study tests if monitoring drug levels in the blood (therapeutic drug monitoring) to adjust doses can better achieve treatment goals in rheumatoid arthritis compared to usual care without such monitoring. Participants will be randomly assigned to either continue with standard care or receive dose adjustments based on their blood test results.

What are the potential side effects?

Since this trial focuses on optimizing the dosage of adalimumab rather than introducing new drugs, side effects would likely be similar to those commonly associated with adalimumab: injection site reactions, increased risk of infection, headaches, rash and gastrointestinal symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 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

12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

+1 more

Secondary study objectives

Percent of participants who achieved low or near remission disease severity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TDM based adalimumab dose optimization groupExperimental Treatment1 Intervention

Therapeutic drug monitoring (TDM) provides an opportunity for a proactive and individualized therapy optimization based on serum drug concentration and anti-drug antibodies development.

Group II: Standard of careActive Control1 Intervention

Standard of care practice for RA management is based on disease activity guided therapy adjustments.

Do I qualify?Apply below to find out

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

The most common treatments for Rheumatoid Arthritis (RA) include TNF inhibitors like adalimumab, methotrexate, and JAK inhibitors. TNF inhibitors work by blocking tumor necrosis factor (TNF), a pro-inflammatory cytokine that plays a key role in the inflammatory process of RA, thereby reducing inflammation and preventing joint damage. Methotrexate, often used as the first-line DMARD, inhibits dihydrofolate reductase, leading to reduced DNA synthesis and immunosuppressive effects. JAK inhibitors, such as tofacitinib, block Janus kinase pathways involved in the signaling of various cytokines, thus reducing inflammation. Understanding these mechanisms is crucial for RA patients as it helps in selecting the most effective treatment tailored to their specific disease activity and monitoring needs, potentially improving outcomes and minimizing adverse effects.