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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessments are performed about 1 hour before first treatment injection
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have rheumatoid arthritis confirmed by a specific blood test.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
Inflammation
Secondary outcome measures
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

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
16,222 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary conditions that Acthar Injectable Product is used to treat?

"Acthar Injectable Product can be used to treat scalp structure, multiple sclerosis, and ulcerative colitis."

Answered by AI

Can patients still sign-up for this research project?

"According to the latest information found on clinicaltrials.gov, this particular trial is not currently looking for new participants. This study was originally posted on October 2nd, 2018 and was last edited on July 18th, 2022. Although this research is not presently looking for patients, there are 923 other studies that are."

Answered by AI

What are the goals that researchers hope to achieve with this trial?

"The primary outcome of this study will be the degree of inflammation after a short-term treatment, as measured by a pathologist during histological assessment. This will be done over a period of five days after the first injection. Secondary outcomes include the number of tender and swollen joints after long-term treatment, as measured by a clinician while palpating 28 specified joints. Another secondary outcome is the initial erythrocyte sedimentation rate (ESR) present in blood (in mm/h). This is defined as the Westergren method, which requires collecting 2 ml of venous blood into a tube containing 0.5 ml of"

Answered by AI

Are there other similar medical trials that have used Acthar Injectable Product?

"Currently, there are 160 clinical trials underway for the Acthar Injectable Product. Of those, 42 are in the third and final stage. Although the majority of trials for this treatment are taking place in Duarte, California, there are a total of 6826 locations running trials for the Acthar Injectable Product."

Answered by AI

Has the Acthar Injectable Product undergone FDA approval?

"Acthar Injectable Product's safety is estimated to be a 3. This is due to the product being in Phase 3 trials, which suggests that while there is data supporting its efficacy, there is also data supporting its safety from multiple rounds of testing."

Answered by AI

How many patients will be taking part in this clinical trial?

"This clinical trial is no longer recruiting patients. The study was first posted on October 2nd, 2018 and was last updated on July 18th, 2022. There are currently 763 other trials for rheumatoid arthritis and 160 trials for Acthar Injectable Product that are actively enrolling participants."

Answered by AI
~1 spots leftby Apr 2025