Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Subcutaneous Abatacept, Ultrasound
Brief summary
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.
Interventions
DRUGabatacept
125 mg once a week up to 12 months.
Sponsors
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years old 2. Has a diagnosis of rheumatoid arthritis 3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) 4. Disease activity score DAS28/ESR \> 3.2 or all must be met: TJC (tender joint count)\>=4, SJC (swollen joint count)\>=4 5. Must be able to understand information in the Informed Consent and comply with study requirements 6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score \>=1 for at least 2 joints and total synovitis score \>=1 for at least 1 joint
Exclusion criteria
1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.) 2. Pregnancy or breast feeding 3. Daily prednisone \> 10mg (stable dose for at least 1 month) 4. Intra-articular steroid injection of the wrist or joints within last 2 months 5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis 6. History of cancer 7. Previous exposure to abatacept
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score | baseline, 12 months | The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Change in Power Doppler Ultrasound (PDUS) Scores | baseline, 12 months | There were seven different joints in the hands and wrists evaluated to score the PDUS. |
| 12 Month Change in Gray-scale Ultrasound (GSUS) | baseline, 12 months | There were seven different joints in the hands and wrists evaluated to score the GSUS. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous Abatacept All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Subcutaneous Abatacept |
|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: baseline, 12 months
Population: Total of 19 patients completed 12 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Abatacept | 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score | 11.4 units on a scale | Standard Deviation 13.1 |
Comparison: Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.p-value: <0.01t-test, 2 sided
Secondary
12 Month Change in Gray-scale Ultrasound (GSUS)
There were seven different joints in the hands and wrists evaluated to score the GSUS.
Time frame: baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Abatacept | 12 Month Change in Gray-scale Ultrasound (GSUS) | 1.2 units on a scale | Standard Deviation 3.7 |
Comparison: 7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.p-value: 0.19t-test, 2 sided
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.
Time frame: baseline, 12 months
Population: As stated previously
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Abatacept | 12 Month Change in Power Doppler Ultrasound (PDUS) Scores | 3.0 units on a scale | Standard Deviation 3.7 |
Comparison: 7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.p-value: <0.01t-test, 2 sided