Clinical trial NCT05460390: Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
Official title: Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Therapeutic drug monitoring (TDM)
Optimal trough drug concentration
Adalimumab dose optimization
Routine Assessment of Patient Index Data 3 (RAPID3)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: American Society of Health-System Pharmacists
First posted: 2022-07-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Starting or already being treated with standard dose adalimumab, 40 mg subcutaneously (SQ) every two weeks
* Good medication adherence rate defined as Proportion of Days Covered (PDC) 80% and above

Exclusion Criteria:

* Detectable anti-adalimumab antibodies
* Overlapping immune mediated diseases
* Steroid therapy for more than 2 months prior to study enrollment
* Poor medication adherence rate (PDC \< 80%)
* History of recurrent infection resulting in therapy pause
* Pregnant or lactating

Primary outcomes:
measure: 3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
timeFrame: baseline, 3 months
measure: 6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
timeFrame: baseline, 6 months
measure: 9 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
timeFrame: baseline, 9 months
measure: 12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Percent of participants who achieved low or near remission disease severity
timeFrame: baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center, Rheumatology Clinic
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Pharmacy
name: Amanuel Kehasse, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: