A Phase 4 interventional study of Abatacept in Rheumatoid Arthritis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University of Washington · Phase 4, Interventional, and Other
The primary objective of this study is to evaluate if baseline levels of T cell associated biomarkers predict efficacy of abatacept during 24 weeks of treatment in patients with moderate to severe active Rheumatoid Arthritis (RA) who have had an inadequate response to conventional disease modifying anti-rheumatic drugs (cDMARDs)
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 25 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laboratory exclusion criteria at screening including:
Abatacept 125mg subcutaneous injection weekly for 24 weeks
Drug: Abatacept
All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks
Also known as: Orencia
Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14
Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time frame: 14 Weeks
Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time frame: 24 Weeks
Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time frame: Week 24
Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time frame: Week 24
Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept
Time frame: Week 24
| Milestone | Abatacept |
|---|---|
| Started | 25 |
| Completed | 23 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 1 |
Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
| participants | Abatacept |
|---|---|
| Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14 | 9 |
Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
| participants | Abatacept |
|---|---|
| Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 | 14 |
Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
| participants | Abatacept |
|---|---|
| Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 | 10 |
Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
| participants | Abatacept |
|---|---|
| Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24 | 3 |
Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept
| participants | Abatacept |
|---|---|
| Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 | 17 |
Collected over From time of study drug administration to end of study (week 24 or safety follow-up visit, if needed), up to 39 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abatacept | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| Event | Abatacept |
|---|---|
| upper respiratory infectionInfections and infestations | 3/25 |
| headachesNervous system disorders | 3/25 |
| abdominal painGastrointestinal disorders | 2/25 |
| Age, Categorical(Participants) | Abatacept |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Abatacept |
|---|---|
| Female | 22 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Abatacept |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 18 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Abatacept |
|---|---|
| United States | 25 |
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University of Washington