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Tests treatment safety and results for Gout Arthritis
Official title Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
ClinicalTrials.gov ID: NCT07346079
What this study is testing
What is Purified Cortophin Gel, 40 U?
Purified Cortophin Gel, 40 U is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for gout arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare. The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Signed informed consent to participate in this study
- Male and female patients, aged 18-85 years
- Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
- Onset of current acute gout flare within 5 days prior to study entry
- Body mass index of less than or equal to 45 kg/m2
You likely can't join if
- Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2...
- Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
- Rheumatoid arthritis, evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Polyarticular gouty arthritis involving more than 4 joints.
- Participation in another concurrent investigational study within 30 days of randomization or has taken an investigational drug within five times the...
- Previous inclusion in this study.
See the full eligibility criteria
- Signed informed consent to participate in this study
- Male and female patients, aged 18-85 years
- Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
- Onset of current acute gout flare within 5 days prior to study entry
- Body mass index of less than or equal to 45 kg/m2
- Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
- History of ≥ 1 gout flares within the 12 months prior to study entry
- The patient meets at least one of the following criteria for both NSAIDs and colchicine treatment options:
- Minimum of one episode of being intolerant, or unresponsive to the treatment, see Appendices 2-4.
- The investigator deems the patient is either contraindicated or inappropriate for the treatment. Inappropriateness could be due to anticipated changes in patient status (i.e., such as worsening of comorbidities or use...
- Patients must be willing and capable of using an electronic device (e.g., cellphone) and must have access to a cellphone to be able to complete surveys.
- Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2 weeks prior to randomization or have an unhealed operation wound(s))...
- Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
- Rheumatoid arthritis, evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Polyarticular gouty arthritis involving more than 4 joints.
- Participation in another concurrent investigational study within 30 days of randomization or has taken an investigational drug within five times the half-life of that investigational drug has passed.
- Previous inclusion in this study.
- Presence of severe renal function impairment: estimated creatinine clearance \<30 mL/min/1.73m2 (CKD stages 4 and 5).
- Uncontrolled clinically significant hematologic, CNS, hepatic, pulmonary, gastrointestinal, metabolic, or endocrine disease as deemed by the investigator.
- Presence of any medical or psychological condition or laboratory result that might create risk to the patients (or interfere with the patient's ability to comply with the protocol requirements, or to complete the study)...
- Prior or current treatment with any ACTH product.
- Pregnant or nursing (lactating) women. Women of childbearing age are required to be using an acceptable method of contraception.
- Patients taking urate-lowering therapy had to be on a stable dose and regimen for ≥2 weeks before entering the study and remain on a stable dosage and regimen for at least 1 week after Purified Cortrophin® Gel.
- Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol/acetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor [TNF] inhibitors) within specified...
- Vaccination within 30 days prior to study enrollment and during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.