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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: 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.
No Intervention
Standard of care 		Standard of care practice for RA management is based on disease activity guided therapy adjustments.

Recruiting Locations

Boston Medical Center, Rheumatology Clinic
Boston, Massachusetts 02118
Contact:
Amanuel Kehasse, PharmD, PhD
617-638-1837
amanuel.kehasse@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Amanuel Kehasse, PharmD, PhD
(617) 638-1837
amanuel.kehasse@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.