Dr. Norman Gaylis, MD
Claim this profileArthritis & Rheumatic Disease Specialties
Studies Systemic Lupus Erythematosus
Studies Arthritis
9 reported clinical trials
15 drugs studied
Affiliated Hospitals
Clinical Trials Norman Gaylis, MD is currently running
Litifilimab
for Lupus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.
Recruiting1 award Phase 3
Pegloticase + Methotrexate
for Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.
Recruiting3 awards Phase 4
More about Norman Gaylis, MD
Clinical Trial Related5 years of experience running clinical trials · Led 9 trials as a Principal Investigator · 4 Active Clinical TrialsTreatments Norman Gaylis, MD has experience with
- Placebo
- BMS-986165
- SetPoint System
- Otilimab (GSK3196165)
- Amniotic Suspension Allograft
- GSK3196165 (Otilimab)
Breakdown of trials Norman Gaylis, MD has run
Systemic Lupus Erythematosus
Arthritis
- Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
- Vagus Nerve Stimulation for Rheumatoid Arthritis
- Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
Rheumatoid Arthritis
- Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
- Vagus Nerve Stimulation for Rheumatoid Arthritis
- Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
Osteoarthritis
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Frequently asked questions
Do I need insurance to participate in a trial?
Almost all clinical trials will cover the cost of the ‘trial drug’ — so no insurance is required for this. For trials where this trial drug is given alongside an already-approved medication, there may be a cost (which your insurance would normally cover).
What does Norman Gaylis, MD specialize in?
Norman Gaylis, MD focuses on Systemic Lupus Erythematosus and Arthritis. In particular, much of their work with Systemic Lupus Erythematosus has involved treating patients, or patients who are undergoing treatment.
Is Norman Gaylis, MD currently recruiting for clinical trials?
Yes, Norman Gaylis, MD is currently recruiting for 4 clinical trials in Aventura Florida. If you're interested in participating, you should apply.
Are there any treatments that Norman Gaylis, MD has studied deeply?
Yes, Norman Gaylis, MD has studied treatments such as Placebo, BMS-986165, SetPoint System.
What is the best way to schedule an appointment with Norman Gaylis, MD?
Apply for one of the trials that Norman Gaylis, MD is conducting.
What is the office address of Norman Gaylis, MD?
The office of Norman Gaylis, MD is located at: Arthritis & Rheumatic Disease Specialties, Aventura, Florida 33180 United States. This is the address for their practice at the Arthritis & Rheumatic Disease Specialties.
Is there any support for travel costs?
The coverage of travel expenses can vary greatly between different clinical trials. Please see more financial detail in the trials you’re interested to apply.