← Back to Search

Monoclonal Antibodies

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

N/A
Recruiting
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
Diagnosis of rheumatoid arthritis
Starting or already being treated with standard dose adalimumab, 40 mg subcutaneously (SQ) every two weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months
Awards & highlights

TDM-RA Trial Summary

This trial is testing whether a proactive, individualized approach to therapy optimization, based on serum drug levels and the presence or absence of anti-drug antibodies, results in a higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with RA.

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.Check my eligibility
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.See study design
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.

TDM-RA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with rheumatoid arthritis.
Select...
I am taking or starting adalimumab, 40 mg under the skin every two weeks.

TDM-RA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Percent of participants who achieved low or near remission disease severity

TDM-RA 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.

Find a Location

Who is running the clinical trial?

American Society of Health-System PharmacistsOTHER
4 Previous Clinical Trials
327 Total Patients Enrolled
Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,409 Total Patients Enrolled
Amanuel Kehasse, PharmD, PhDPrincipal InvestigatorBoston Medical Center, Pharmacy

Media Library

Adalimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05460390 — N/A
Rheumatoid Arthritis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT05460390 — N/A
Adalimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05460390 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are eligible to partake in this research trial?

"Yes, the information on clinicaltrials.gov states that this trial is actively looking for participants to join. It was first advertised on October 26th 2022 and last updated one day later; 50 patients are required from 1 location."

Answered by AI

Is this medical experiment open to new participants?

"As indicated by clinicaltrials.gov, this trial is actively enrolling patients with the most recent update taking place on October 27th 2022. The study was originally posted online just a day earlier on October 26th 2022."

Answered by AI
~5 spots leftby Jun 2024