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Corticosteroid
Acthar for Rheumatoid Arthritis
Phase 4
Recruiting
Led By Veena K Ranganath, M.D., M.S.
Research Sponsored by Veena Ranganath, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
Summary
This trial is testing whether Acthar, a medication used to treat flares in RA, can help improve symptoms as measured by MSUS and disease activity scores.
Who is the study for?
This trial is for adults over 18 with Rheumatoid Arthritis who have a certain level of disease activity and inflammation. They should be on stable RA medications but not have used Acthar recently or received live vaccines in the past 6 weeks.
What is being tested?
The study tests if Acthar can improve inflammation and disease activity in RA flares, measured by ultrasound scores and other assessments. It's to see how effective Acthar is during these flare-ups.
What are the potential side effects?
Acthar may cause side effects such as increased blood pressure, mood changes, weight gain, high blood sugar levels, increased risk of infections, digestive issues, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
DAS28
Ultrasound Power Doppler Score
Secondary study objectives
HAQ-DI
Ultrasonography
Trial Design
2Treatment groups
Active Control
Group I: 40 UnitsActive Control1 Intervention
40 units of Acthar per week
Group II: 80 UnitsActive Control1 Intervention
80 units of Acthar twice per week
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Who is running the clinical trial?
Veena Ranganath, MD, MSLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
40 Patients Enrolled for Rheumatoid Arthritis
Dr. Veena RanganathLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
40 Patients Enrolled for Rheumatoid Arthritis
Veena K Ranganath, M.D., M.S.Principal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
40 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: 40 Units
- Group 2: 80 Units
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT02541955 — Phase 4
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