Rheumatoid Arthritis (RA)Phase 4NCT02541955
Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
A Phase 4 study testing Acthar in people with Rheumatoid Arthritis (RA), run by Veena Ranganath, MD, MS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Acthar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 20 May 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must meet 1987 ACR criteria
- Age > 18 years of age
- Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2
- Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
- Stable prednisone <10mg or equivalent
- Power Doppler score of >=10
Who cannot join
- Prior treatment with Acthar in the past 2mos
- Meet one of the above RA flare requirements
- Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, 90095
About this study
Official title: Use of Acthar in Rheumatoid Arthritis Related Flares
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Acthar
- Keywords
- Rheumatoid arthritis (RA), Musculoskeletal ultrasound (MSUS)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActharDrug
Also called Repository corticotropin injection
Injections will be self administered
| Study group | Role | What they receive |
|---|---|---|
| 40 Units | Active comparator | 40 units of Acthar per week Receives: Drug: Acthar |
| 80 Units | Active comparator | 80 units of Acthar twice per week Receives: Drug: Acthar |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28
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.
Measured: Baseline to 4 Weeks
Power Doppler Ultrasound Score
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.
Measured: Baseline to 4 Weeks
Secondary outcomes (2)
Ultrasound Grey Scale Synovial Hypertrophy Score
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.
Measured: Baseline to 4 Weeks
HAQ-DI
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.
Measured: Baseline to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start20 Jul 2017
- Primary completion6 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veena Ranganath, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Veena Ranganath, MD, MS, University of California, Los Angeles
- Investigators
- Veena K Ranganath, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541955
- Sponsor's protocol ID
- Acthar in Rheumatoid Arthritis
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2015
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No