Rheumatoid Arthritis (RA)
Conditions
Keywords
Rheumatoid arthritis (RA), Musculoskeletal ultrasound (MSUS)
Brief summary
This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.
Detailed description
Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status. Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.
Interventions
DRUGActhar
Injections will be self administered
Sponsors
Veena Ranganath, MD, MS
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must meet 1987 ACR criteria 2. Age \> 18 years of age 3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) \>=3.2 4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) 5. Stable prednisone \<10mg or equivalent 6. Power Doppler score of \>=10
Exclusion criteria
1. Prior treatment with Acthar in the past 2mos 2. Meet one of the above RA flare requirements 3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS28 | Baseline to 4 Weeks | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6. |
| Power Doppler Ultrasound Score | Baseline to 4 Weeks | 34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Grey Scale Synovial Hypertrophy Score | Baseline to 4 Weeks | 34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level. |
| HAQ-DI | Baseline to 4 Weeks | The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0, with higher scores indicating worse function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVeena K Ranganath, M.D., M.S.
University of California, Los Angeles
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 14.96 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian / Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic Black | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic White | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Prefer Not to Say | 1 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 20 / 20 | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed