Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IND 111281 | Other Identifier | FDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.
The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Abatacept | Experimental | All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept | Drug | 125 mg once a week up to 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score | The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores. | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12 Month Change in Power Doppler Ultrasound (PDUS) Scores | There were seven different joints in the hands and wrists evaluated to score the PDUS. | baseline, 12 months |
| 12 Month Change in Gray-scale Ultrasound (GSUS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Veena K Ranganath, M.D. | UCLA David Geffen School of Medicine, Division of Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36828925 | Derived | Charles-Schoeman C, Wang J, Shahbazian A, Wilhalme H, Brook J, Kaeley GS, Oganesian B, Ben-Artzi A, Elashoff DA, Ranganath VK. Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis. Rheumatol Int. 2023 Jun;43(6):1041-1053. doi: 10.1007/s00296-023-05285-7. Epub 2023 Feb 24. |
Not provided
Not provided
Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.
A total of 34 RA patients were recruited from the UCLA rheumatology clinics between September 2011 to February 2013. However, we had a total of 9 screen fails.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous Abatacept | All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous Abatacept | All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This is a the average age of the cohort that started the mediation, Abatacept 125mg sq qwk. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score | The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores. | Total of 19 patients completed 12 mos | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months |
|
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subcutaneous Abatacept | All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. |
Not provided
Not provided
This is a very small open-label study of 25 patients on a FDA approved drug, where efficacy (by standard validated measures) and safety were not the primary end points.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Veena K. Ranganath, MD, MS Assistant Clinical Professor | UCLA | 310-825-3061 | vranganath@mednet.ucla.edu |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There were seven different joints in the hands and wrists evaluated to score the GSUS.
| baseline, 12 months |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 12 Month Change in Power Doppler Ultrasound (PDUS) Scores | There were seven different joints in the hands and wrists evaluated to score the PDUS. | As stated previously | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months |
|
|
|
|
| Secondary | 12 Month Change in Gray-scale Ultrasound (GSUS) | There were seven different joints in the hands and wrists evaluated to score the GSUS. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |