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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02541955
Date of registration: 01/09/2015
Prospective Registration: Yes
Primary sponsor: Dr. Veena Ranganath
Public title: Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
Scientific title: Use of Acthar in Rheumatoid Arthritis Related Flares
Date of first enrolment: July 20, 2017
Target sample size: 40
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02541955
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Veena K Ranganath, M.D.
Address: 
Telephone: 310-825-6301
Email: vranganath@mednet.ucla.edu
Affiliation: 
Name:     Veena K Rangantah, M.D., M.S.
Address: 
Telephone: 310-825-3061
Email: vranganath@mednet.ucla.edu
Affiliation: 
Name:     Veena K Ranganath, M.D., M.S.
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis (RA)
Intervention(s)
Drug: Acthar
Primary Outcome(s)
DAS28 [Time Frame: Baseline to 2 Weeks]
Ultrasound Power Doppler Score [Time Frame: Baseline to 2 Weeks]
Secondary Outcome(s)
HAQ-DI [Time Frame: Baseline to 4 Weeks]
Ultrasound Grey Scale Synovial Hypertrophy score [Time Frame: Baseline to 2 Weeks]
Secondary ID(s)
Acthar in Rheumatoid Arthritis
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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