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NCT05460390 · ClinicalTrials.gov registry record · NA
Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05460390 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 5 participants.
The verdict
NCT05460390, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
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.
Interventions
- OTHER Therapeutic drug monitoring (TDM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2024-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05460390
The ClinicalTrials.gov registry entry for NCT05460390 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Therapeutic drug monitoring (TDM) is the first listed.
NCT05460390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05460390 about?
NCT05460390 is a clinical study titled "Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis". 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...
What is the current status of trial NCT05460390?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2022-10-26. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT05460390?
The interventions under investigation include: Therapeutic drug monitoring (TDM) (OTHER).
Who is sponsoring clinical trial NCT05460390?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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