Rheumatoid ArthritisTDM-RANCT05460390
Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
A study testing Therapeutic drug monitoring (TDM) in people with Rheumatoid Arthritis, run by Boston Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Therapeutic drug monitoring (TDM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, Rheumatology Clinic
Boston, Massachusetts, 02118
About this study
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
- Being tested
- Therapeutic drug monitoring (TDM)
- Keywords
- Therapeutic drug monitoring (TDM), Optimal trough drug concentration, Adalimumab dose optimization, Routine Assessment of Patient Index Data 3 (RAPID3)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 12 months
Secondary outcomes (1)
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.
Measured: baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start26 Oct 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Unable to recruit enough participants so the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Responsible party
- Sponsor
- Investigators
- Amanuel Kehasse, PharmD, PhD, Principal investigator, Boston Medical Center, Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460390
- Sponsor's protocol ID
- H-42873
- Acronym
- TDM-RA
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05460390
- Acronym / sponsor ID
- TDM-RA / H-42873
- Conditions
- Rheumatoid Arthritis
- Keywords
- Therapeutic drug monitoring (TDM), Optimal trough drug concentration, Adalimumab dose optimization, Routine Assessment of Patient Index Data 3 (RAPID3)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough participants so the study was closed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDM based adalimumab dose optimization group | Experimental | Other: Therapeutic drug monitoring (TDM)Therapeutic drug monitoring (TDM) provides an opportunity for a proactive and individualized therapy optimization based on serum drug concentration and anti-drug antibodies development. |
| Standard of care | No intervention | –Standard of care practice for RA management is based on disease activity guided therapy adjustments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | TDM based adalimumab dose optimization group |
Primary outcome
3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
Time frame: baseline, 3 months
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.
6 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
Time frame: baseline, 6 months
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.
9 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
Time frame: baseline, 9 months
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.
12 months change in proportion of patients with RA who achieve and maintain remission or low disease activity
Time frame: baseline, 12 months
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.
1 secondary outcome
Percent of participants who achieved low or near remission disease severity
Time frame: baseline, 3 months, 6 months, 12 months
Results and safety
The study was stopped early (reason given: Unable to recruit enough participants so the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanuel Kehasse, PharmD, PhD principal investigator
Boston Medical Center, Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic drug monitoring (TDM) in people with Rheumatoid Arthritis, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit enough participants so the study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 months change in proportion of patients with RA who achieve and maintain remission or low disease activity (time frame: baseline, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.