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

Rheumatoid Arthritis Clinical Trial

— TDM-RA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460390
• Other study ID #: H-42873
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Boston Medical Center
• Contact: Amanuel Kehasse, PharmD, PhD
• Phone: (617) 638-1837
• Email: amanuel.kehasse[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center, Rheumatology Clinic	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	American Society of Health-System Pharmacists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Percent of participants who achieved low or near remission disease severity	This will be assessed with the Routine Assessment of Patient Index Data 3 (RAPID3) which is a composite disease activity index consisting of the 3 Patient Reported Outcomes, disability, pain, and patient global assessment of disease activity. Scores can range from 0 to 30 and low or near remission disease severity is defined as patients with RAPID3 disease severity score of 3.1-6 and =3 respectively.	baseline, 3 months, 6 months, 12 months