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

Palo Alto (17 mi)

Overseen byAmanuel Kehasse, PharmD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Boston Medical Center

No Placebo Group

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Treatment Details

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.

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.

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Humira for: