Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis

NCT ID: NCT05460390

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2024-06-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

TDM based adalimumab dose optimization group

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 Type: EXPERIMENTAL

Therapeutic drug monitoring (TDM)

Intervention Type: OTHER

Serum trough level of adalimumab and anti-adalimumab antibody will be obtained at time of enrollment and every 3 months until the end of the study. Adalimumab dose optimization goal will be to achieve trough drug level in the range of 5 -8 μg/mL.

Standard of care

Standard of care practice for RA management is based on disease activity guided therapy adjustments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapeutic drug monitoring (TDM)

Serum trough level of adalimumab and anti-adalimumab antibody will be obtained at time of enrollment and every 3 months until the end of the study. Adalimumab dose optimization goal will be to achieve trough drug level in the range of 5 -8 μg/mL.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Health-System Pharmacists

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanuel Kehasse, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Pharmacy

Locations

Boston Medical Center, Rheumatology Clinic

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-42873

Identifier Type: -

Identifier Source: org_study_id