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Corticosteroid

Acthar + Depo Medrol for Rheumatoid Arthritis

Phase 3
Waitlist Available
Led By Swamy R Venuturupalli, MD, FACR
Research Sponsored by Attune Health Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis
Be older than 18 years old
Must not have
Patients on anti-coagulation therapy
Patients with an active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessments are performed about 1 hour before first treatment injection
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test whether Depo Medrol or Acthar is more effective in treating lupus patients.

Who is the study for?
This trial is for people with Rheumatoid Arthritis who test positive for Anti-Cyclic Citrullinated Peptide, have moderate to severe disease activity, and at least one joint that's tender, swollen, shows signs of inflammation on ultrasound, and can be biopsied. It's not for those on blood thinners, with a history of joint infections or certain fungal diseases like tuberculosis or coccidioidomycosis, recent corticosteroid use unless tapering off under supervision.
What is being tested?
The study compares the effects of two treatments: Acthar Injectable Product and Depo Medrol. Participants will receive one treatment randomly and undergo synovial biopsies (joint tissue sampling), blood tests, fluid collection from joints, and physician assessments before and after starting the treatment.
What are the potential side effects?
Possible side effects include reactions at injection sites such as pain or swelling; hormonal imbalances; increased risk of infections; mood swings; high blood pressure; blood sugar changes; weight gain. Specific side effect profiles may vary between Acthar and Depo Medrol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have rheumatoid arthritis confirmed by a specific blood test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on blood thinner medication.
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I currently have an active infection.
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I have had a joint infection in the past.
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I have had tuberculosis or coccidioidomycosis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessments are performed about 1 hour before first treatment injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessments are performed about 1 hour before first treatment injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
Inflammation
Secondary study objectives
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ActharExperimental Treatment1 Intervention
80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.
Group II: Depo MedrolActive Control1 Intervention
40 milligrams of Depo Medrol will be injected intramuscularly one time

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,860 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
159 Patients Enrolled for Rheumatoid Arthritis
Attune Health Research, Inc.Lead Sponsor
5 Previous Clinical Trials
1,640 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
52 Patients Enrolled for Rheumatoid Arthritis
Swamy R Venuturupalli, MD, FACRPrincipal InvestigatorCEO
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
20 Patients Enrolled for Rheumatoid Arthritis

Media Library

Acthar Injectable Product (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03511625 — Phase 3
Rheumatoid Arthritis Research Study Groups: Acthar, Depo Medrol
Rheumatoid Arthritis Clinical Trial 2023: Acthar Injectable Product Highlights & Side Effects. Trial Name: NCT03511625 — Phase 3
Acthar Injectable Product (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03511625 — Phase 3
~1 spots leftby Nov 2025
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