TDM based adalimumab dose optimization group for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Boston Medical Center, Rheumatology Clinic, Boston, MA
Rheumatoid Arthritis+2 More
Therapeutic drug monitoring (TDM) - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical assessment of disease activity to adjust therapy. For the most part, therapy adjustment for therapy non-response and/or suboptimal therapy response leads to therapy switch within the same class of therapy or to a different class of therapy. The lack of objective data to titrate dose of a given therapeutic agent for maximal possible efficacy makes it difficult for providers and payors to titrate dose as needed. Therapeutic drug monitoring (TDM) provides objective data for a proactive and individualized therapy optimization based on serum drug levels and the presence or absence of anti-drug antibodies. Maintaining optimal trough drug concentration is a proven concept of therapeutics. With respect to adalimumab, this approach helps to maximize therapeutic efficacy and prevent anti-adalimumab antibody development. However, lack of drug and disease state specific published data creates a barrier for a wider adoption of TDM into clinical practice. The objective of this single site, open label, randomized, parallel group pilot study is to investigate whether proactive therapeutic drug monitoring based adalimumab dose optimization results in higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with rheumatoid arthritis.

Eligible Conditions

  • Rheumatoid Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Rheumatoid Arthritis

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: baseline, 3 months, 6 months, 12 months

baseline, 12 months
12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
baseline, 3 months
3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
Month 12
Percent of participants who achieved low or near remission disease severity
baseline, 6 months
6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
baseline, 9 months
9 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

Trial Safety

Safety Progress

1 of 3

Other trials for Rheumatoid Arthritis

Trial Design

2 Treatment Groups

Standard of care
1 of 2
TDM based adalimumab dose optimization group
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: TDM based adalimumab dose optimization group · No Placebo Group · N/A

TDM based adalimumab dose optimization group
Other
Experimental Group · 1 Intervention: Therapeutic drug monitoring (TDM) · Intervention Types: Other
Standard of careNoIntervention Group · 1 Intervention: Standard of care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months, 12 months
Closest Location: Boston Medical Center, Rheumatology Clinic · Boston, MA
Photo of Boston  1Photo of Boston  2Photo of Boston  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Rheumatoid Arthritis
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are prescribed medication for a minimum of 80% of days in the past 30 days.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.