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Unable to recruit enough participants so the study was closed.
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| Name | Class |
|---|---|
| American Society of Health-System Pharmacists | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of care | No Intervention | Standard of care practice for RA management is based on disease activity guided therapy adjustments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanuel Kehasse, PharmD, PhD | Boston Medical Center, Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center, Rheumatology Clinic | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| baseline, 3 months, 6 months, 12 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |