Purified Cortrophin Gel for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Purified Cortrophin® Gel, a corticosteroid treatment, to evaluate its effectiveness and safety for sudden gout attacks. Gout, a form of arthritis, causes intense joint pain. The study compares two doses of the gel: 40 units and 80 units. Participants who have experienced a gout attack in the last 5 days and at least one flare in the past year may qualify, particularly if common treatments like NSAIDs or colchicine have been ineffective. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial requires that if you are taking urate-lowering therapy, you must be on a stable dose for at least 2 weeks before the study and continue it for at least 1 week after treatment. Some pain relief medications and biologics must not be used within certain periods before joining the trial, but the exact details are not specified here.
What is the safety track record for Purified Cortrophin® Gel?
Research has shown that Purified Cortrophin® Gel is already FDA-approved for other uses, indicating its safety is well understood. However, it is important to avoid this treatment if certain conditions exist, such as scleroderma, a skin condition.
Regarding side effects, limited data suggest that some people might develop antibodies to the gel after prolonged use, meaning the body could start reacting to the treatment over time. Since this trial administers the gel only once, this concern might be less relevant.
The trial tests two doses: 40 U and 80 U. Both doses are being evaluated for safety, and previous studies suggest that Purified Cortrophin® Gel is generally well-tolerated. However, like any medical treatment, there is always a chance of side effects, so discussing participation with a doctor is advisable.1234Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for gout, which often include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or colchicine, Purified Cortrophin Gel offers a unique delivery method and formulation. Researchers are excited about this treatment because it uses a purified form of adrenocorticotropic hormone (ACTH) in a gel format, which might provide targeted relief with potentially fewer systemic side effects. Additionally, the gel's different dosing options (40 U and 80 U) allow for customizable treatment that could better address individual patient needs. This approach might offer a quicker and more tailored response for managing the painful flare-ups associated with gout.
What is the effectiveness track record for Purified Cortrophin® Gel in treating acute gouty arthritis?
Research shows that Purified Cortrophin® Gel effectively treats sudden gout attacks. This gel is the only FDA-approved treatment using ACTH, a hormone that reduces inflammation, specifically for gout. Studies have found that it reduces gout pain within 72 hours of treatment, quickly easing pain in the affected joint. In this trial, participants will receive either a 40 U or 80 U dose of Purified Cortrophin® Gel, administered once as an injection under the skin or into the muscle, making it easy for patients to use.13567
Who Is on the Research Team?
Hyon K Choi, MD, DrPH
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 with acute gout flares, meeting specific gout criteria, and who've had a flare within the last 5 days. They must have experienced at least one flare in the past year and be intolerant or unresponsive to standard treatments. Participants need a BMI ≤45 kg/m^2, significant pain, and must use an electronic device for surveys.Inclusion Criteria
Timeline for a Trial Participant
Pre-screening
Optional pre-screening period to determine initial eligibility
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of Purified Cortrophin® Gel (40 U or 80 U) and are monitored for efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Purified Cortrophin® Gel
Trial Overview
The study tests two doses of Purified Cortrophin® Gel (40 U and 80 U) on patients with acute gouty arthritis. It's randomized and double-blind; participants receive a single dose subcutaneously or intramuscularly and are monitored over seven days to assess efficacy and safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients in this arm will receive the 80 U dose at Day 0
Patients in this arm will receive the 40 U dose at Day 0
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
ANI Pharmaceuticals
Industry Sponsor
Citations
Purified Cortrophin® Gel Efficacy and Safety Study of 2 ...
Change in gout pain intensity from baseline in the target joint following PCG administration measured by Visual Analog Scale (VAS) at 72 hours ...
2.
investor.anipharmaceuticals.com
investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-initiation-phase-4-clinical-trialANI Pharmaceuticals Announces Initiation of Phase 4 Clinical ...
The primary endpoint of the study is the change in gout pain intensity from baseline in the target joint following Cortrophin Gel administration ...
3.
finance.yahoo.com
finance.yahoo.com/news/ani-pharmaceuticals-announces-initiation-phase-105000299.htmlANI Pharmaceuticals Announces Initiation of Phase 4 ...
Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares. Trial to be conducted by Dr.
ANI Pharma initiates phase 4 trial of purified Cortrophin Gel ...
The primary endpoint of the study is the change in gout pain intensity from baseline in the target joint following Cortrophin Gel administration ...
Clinical Efficacy Guidelines
Due to the lack of updated clinical efficacy data and potential safety concerns with long-term use, approval is not recommended for Cortrophin Gel.
Patient Brochure for Acute Gouty Arthritis Flare Management
Important Safety Information. DO NOT use Cortrophin Gel if you have any of the following conditions: • A skin condition called scleroderma.
Purified Cortrophin Gel (Repository Corticotropin Injection USP)
Limited available data suggest that a patient may develop antibodies to Purified Cortrophin Gel after chronic administration and loss of endogenous ACTH and ...
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