Acthar for Rheumatoid Arthritis

Overseen By Veena K Rangantah, M.D., M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Veena Ranganath, MD, MS

Must be taking: DMARDs, Prednisone

Disqualifiers: Prior Acthar, Recent live vaccines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on determining whether Acthar (repository corticotropin injection) can reduce inflammation and disease activity in individuals with Rheumatoid Arthritis (RA) during flare-ups. The study examines the effects of different Acthar doses—40 units per week or 80 units twice a week—on RA symptoms. Ideal participants have experienced frequent RA flare-ups, are on stable RA medications, and have not recently used Acthar. They should also possess measurable inflammation markers. The trial aims to assess whether Acthar can significantly improve RA symptom management. As a Phase 4 trial, Acthar is already FDA-approved and effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stay on your current medications if they are stable Disease Modifying Anti-Rheumatic Drugs (DMARDs) or prednisone less than 10mg.

What is the safety track record for Acthar?

Research has shown that Acthar Gel is usually well-tolerated by individuals with autoimmune disorders such as rheumatoid arthritis. In a 24-week study involving 259 participants, those using Acthar Gel found it effective and monitored any side effects. Most participants experienced no serious issues.

Acthar Gel has FDA approval for several conditions, indicating its well-established safety profile. However, as with any treatment, some individuals might experience mild side effects. Consulting a doctor about any concerns before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Acthar is unique for rheumatoid arthritis because it works by stimulating the body's production of natural hormones that help reduce inflammation, differing from standard treatments like NSAIDs or DMARDs that directly target inflammation or immune response. Researchers are excited about Acthar because it offers a potential alternative for patients who do not respond well to traditional therapies. Additionally, Acthar's ability to be administered in different dosages, such as 40 units per week or 80 units twice per week, provides flexibility in treatment plans tailored to individual patient needs.

What is the effectiveness track record for Acthar in treating rheumatoid arthritis?

Research has shown that Acthar Gel can help treat rheumatoid arthritis (RA). In one 24-week study, 259 people with RA used Acthar Gel and saw promising results. The FDA has approved this treatment for several autoimmune disorders, indicating its reliability in reducing inflammation. Real-world studies also confirm that Acthar Gel is safe and effective for people with hard-to-treat RA. These findings support Acthar's ability to help manage RA symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Veena K Ranganath, M.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2

Patient must meet 1987 ACR criteria

Power Doppler score of >=10

Exclusion Criteria

Prior treatment with Acthar in the past 2 months

Meet one of the above RA flare requirements

Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acthar treatment for RA flares, with doses of either 40 units per week or 80 units twice a week

4 weeks

Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including MSUS, DAS28, CDAI, RAPID3, and HAQ-DI

3 months

Visits at 2 weeks, 1 month, and 3 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Acthar

Trial Overview 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.

How Is the Trial Designed?

Group I: 40 Units Active Control 1 Intervention

40 units of Acthar per week

Group II: 80 Units Active Control 1 Intervention

80 units of Acthar twice per week

Acthar is already approved in United States for the following indications:

Approved in United States as Acthar Gel for:

• Rheumatoid Arthritis
• Systemic Lupus Erythematosus (SLE)
• Dermatomyositis and Polymyositis
• Symptoms of Sarcoidosis
• Allergic & Inflammatory Eye Conditions
• Infantile Spasms

Who Is Running the Clinical Trial?

Veena Ranganath, MD, MS

Lead Sponsor

Trials

2

Recruited

80+

Dr. Veena Ranganath

Lead Sponsor

Trials

2

Recruited

80+

Published Research Related to This Trial

In a multicenter, randomized, placebo-controlled trial involving 55 subjects, repository corticotropin injection (RCI) showed greater improvement in a novel sarcoidosis treatment score (STS) compared to placebo, suggesting its potential efficacy in treating pulmonary sarcoidosis.

RCI was found to be safe and well tolerated, with more patients in the RCI group able to discontinue glucocorticoids compared to those receiving placebo, indicating a promising alternative therapy for patients with pulmonary sarcoidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis. Mirsaeidi, M., Baughman, RP., Sahoo, D., et al.[2023]

In a phase IV clinical trial involving patients with refractory rheumatoid arthritis, repository corticotropin injection (RCI) demonstrated significant safety and efficacy, leading to improved clinical measures and patient-reported outcomes over 12 weeks.

Patients who responded to RCI treatment reported greater improvements in pain, fatigue, and disability, with these improvements correlating with significant reductions in clinical measures like total joint count and disease activity scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post Hoc Analysis of the Correlation Between Patient-Reported Outcomes and Clinical Response to Repository Corticotropin Injection for Persistently Active Rheumatoid Arthritis. Fleischmann, R., Hayes, K., Ahn, SW., et al.[2022]

Repository corticotropin injection (RCI) significantly reduces disease activity in rheumatoid arthritis (RA) patients, as evidenced by lower Clinical Disease Activity Index (CDAI) scores and improved patient-reported outcomes after one year of treatment.

Patients treated with RCI also showed a decreased reliance on other medications, including conventional and biologic disease-modifying antirheumatic drugs (DMARDs) and nonsteroidal anti-inflammatory drugs (NSAIDs), indicating its potential to simplify RA management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Treatment Patterns and Outcomes from an Electronic Medical Records Database for Patients with Rheumatoid Arthritis Treated with Repository Corticotropin Injection. Hayes, K., Panaccio, MP., Houston, P., et al.[2022]

Repository corticotropin injection (RCI) is safe for short-term use as an adjunctive therapy in patients with rheumatoid arthritis (RA) who have persistent disease activity, showing no significant differences in adverse event profiles compared to standard DMARD and glucocorticoid treatments.

The findings are based on a clinical trial (ClinicalTrials.gov identifier NCT02919761) and a systematic review of literature, indicating that RCI can be effectively integrated into RA treatment regimens without increasing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. Fleischmann, R., Furst, DE.[2022]

Acthar® Gel has been shown to have both steroidogenic and nonsteroidogenic immunomodulatory effects, making it a versatile treatment option for various autoimmune and inflammatory diseases.

Over 500 studies have demonstrated the safety and efficacy of Acthar in patients who did not respond well to standard treatments, highlighting its importance in managing conditions like rheumatoid arthritis and multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acthar® Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence. Kaplan, J., Askanase, A., Chu, D., et al.[2023]

In a retrospective analysis of 63 rheumatoid arthritis patients, Repository Corticotropin Injection (RCI) demonstrated safety and effectiveness, leading to significant reductions in disease activity scores and decreased reliance on glucocorticoids and opioids after 12 months.

The study highlights that RCI can be a beneficial adjunctive treatment for patients with refractory rheumatoid arthritis, with few discontinuations due to side effects, although the small sample size and incomplete data are noted as limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world treatment patterns for repository corticotropin injection in patients with rheumatoid arthritis. Busch, H., Wan, GJ., Niewoehner, J., et al.[2022]

Citations

1. acthar.com acthar.com/rheumatoid-arthritis/

Rheumatoid Arthritis | Acthar® Gel (repository corticotropin ... A 24-week clinical trial looked at whether Acthar Gel was effective in treating people with RA. The 2-part study examined 259 people who had taken Acthar Gel.

2. ir.mallinckrodt.com ir.mallinckrodt.com/news-releases/news-release-details/mallinckrodt-presents-data-real-world-outcomes-actharr-gel

Release Details - Investor Relations Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8966709/

Real-world treatment patterns for repository corticotropin ... In a recent clinical trial, RCI was safe and effective for the treatment of refractory rheumatoid arthritis (RA). This study aims to describe real-world use and ...

4. actharhcp.com actharhcp.com/clinical-experience/rheumatoid-arthritis/fleischmann/

Rheumatoid arthritis Phase 4 study A multicenter study assessing the efficacy and safety of repository corticotropin injection in patients with persistently active rheumatoid arthritis.

5. prnewswire.com prnewswire.com/news-releases/mallinckrodt-announces-publication-of-findings-on-treatment-patterns-and-outcomes-in-patients-with-two-types-of-arthritis-treated-with-acthar-gel-repository-corticotropin-injection-302558337.html

Mallinckrodt Announces Publication of Findings on ... Mallinckrodt Announces Publication of Findings on Treatment Patterns and Outcomes in Patients with Two Types of Arthritis Treated with Acthar® ...

6. actharhcp.com actharhcp.com/safety-data/

Safety data | Acthar® Gel (repository corticotropin injection) A multicenter study assessing the efficacy and safety of repository corticotropin injection ... Patient reported outcomes in rheumatoid arthritis clinical trials.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10312382/

Acthar Gel (RCI): A Narrative Literature Review of Clinical ... Acthar® Gel (RCI) is approved by the US Food & Drug Administration for the treatment of several autoimmune disorders and medical conditions ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724555157

AB0502 H.P. Acthar® Gel (Repository Corticotropin ... This interim report of an ongoing trial indicates that 80 U Acthar Gel administered subcutaneously every 72 hours for 12 weeks may provide a treatment option ...