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

Trial Summary

What is the purpose of this trial?

This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

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 data supports the effectiveness of the drug Acthar Gel for treating rheumatoid arthritis?

Recent studies and clinical trials have shown that Acthar Gel is safe and effective for treating rheumatoid arthritis, especially in patients who do not respond to standard treatments. It has anti-inflammatory effects and has been used successfully in various autoimmune and inflammatory diseases. ^{1 2 3 4 5}

Is Acthar Gel safe for humans?

Acthar Gel has been studied for safety in various conditions, including rheumatoid arthritis and other inflammatory diseases. Many studies have shown it to be safe for patients, especially those who did not respond well to standard treatments. ^{1 2 4 5 6}

How is Acthar Gel different from other drugs for rheumatoid arthritis?

Acthar Gel is unique because it is a naturally sourced mixture of hormone analogs and peptides that work by activating specific receptors in the body to reduce inflammation and modulate the immune system. It is often used for patients with rheumatoid arthritis who do not respond well to standard treatments. ^{1 2 3 4 5}

Research Team

Veena K Ranganath, M.D.

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Real-world treatment patterns for repository corticotropin injection in patients with rheumatoid arthritis. [2022]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Safety of repository corticotropin injection as an adjunctive therapy for the treatment of rheumatoid arthritis. [2022]

4. New Zealand 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. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Acthar® Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence. [2023]

6. United States 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. [2023]