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

NCT05460390 | Terminated

• 1 other identifier: H-42873
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Therapeutic drug monitoring (TDM); Optimal trough drug concentration; Adalimumab dose optimization; Routine Assessment of Patient Index Data 3 (RAPID3)

Outcome Measures

Primary Outcomes (4)

• 3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

  Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.

  baseline, 3 months

• 6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

  Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.

  baseline, 6 months

• 9 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

  Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.

  baseline, 9 months

• 12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity

  Remission and low disease activity is defined as a Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) score of \<2.6 and 2.6 -3.2 respectively. A DAS-28 reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement.

  baseline, 12 months

Secondary Outcomes (1)

• Percent of participants who achieved low or near remission disease severity

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

TDM based adalimumab dose optimization group

EXPERIMENTAL

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)

Standard of care

NO INTERVENTION

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

Interventions

Therapeutic drug monitoring (TDM) 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.

TDM based adalimumab dose optimization group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• American Society of Health-System Pharmacists: collaborator

Study Sites (1)

Boston Medical Center, Rheumatology Clinic

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Amanuel Kehasse, PharmD, PhD

  Boston Medical Center, Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: October 26, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)