Clinical trial
Use of Acthar in Rheumatoid Arthritis Related Flares
Name
Acthar in Rheumatoid Arthritis
Description
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.
Trial arms
Trial start
2017-07-20
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Acthar
Injections will be self administered
Arms:
40 Units, 80 Units
Other names:
Repository corticotropin injection
Size
40
Primary endpoint
Ultrasound Power Doppler Score
Baseline to 2 Weeks
DAS28
Baseline to 2 Weeks
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-05-07
1 organization
1 product
1 indication
Organization
Veena RanganathProduct
ActharIndication
Rheumatoid Arthritis