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FX201 for Osteoarthritis
Study Summary
This trial will test a new drug, FX201, for treating painful osteoarthritis of the index knee. The trial will have a Single Ascending Dose (SAD) Phase, where a small number of patients will be given gradually increasing doses of the drug to test safety. The trial will also have an Expansion Phase, where a larger number of patients will be given the drug to further test safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I expect to have major surgery during the study.You have given written permission to take part in the study.I use effective birth control methods if I'm sexually active.My heart's electrical activity is unusual and considered significant by a doctor.You have used any experimental medication, biologic, or medical device within the past 3 months.I have tried at least two treatments for my knee arthritis without success.I am between 30 and 80 years old.I haven't had any joint injections in the last 6 months or longer.I experience moderate pain in one of my joints.I have had or currently have an infection in my knee.I have a type of arthritis linked to inflammation or bowel disease.I haven't taken IV antibiotics or antivirals in the last 4 weeks or oral ones in the last 2 weeks.I haven't had or planned knee surgery in the last year.I am between 30 and 80 years old.You are allergic or sensitive to methylprednisolone.I experience moderate pain in one of my joints.I haven't used immunomodulators, immunosuppressives, or chemotherapy in the last 5 years.I have not had cold or radiofrequency nerve treatment on my knee in the last year.I have tried at least two treatments for my knee arthritis without success.I have been diagnosed with knee osteoarthritis and have X-ray evidence.I have been diagnosed with knee osteoarthritis and have X-ray evidence.My knee has been unstable due to injury in the last year.Your body mass index (BMI) is less than 40 kg/m2.I use effective birth control methods if I'm sexually active.
- Group 1: Low Dose FX201
- Group 2: Mid Dose FX201
- Group 3: High Dose FX201
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there vacancies available for people to partake in this experiment?
"According to clinicaltrials.gov, this trial is currently not recruiting participants, last updated on October 17th 2022 after its initial posting of November 30th 2019. Despite that there are 692 other trials open for recruitment at present."
How many research sites have been included in this trial's oversight?
"This clinical trial is being conducted at the Center for Pharmaceutical Research located in Kansas City, Missouri; Arizona Research Centre based out of Phoenix, Arizona; and Metroplex Clinical Research Centre positioned in Dallas, Texas. There are also 8 additional sites where patients can participate."
What risks have been documented with FX201 usage?
"The safety of FX201 is rated at 1, as the clinical trial for this drug intervention is still in its early stages. Consequently, there is limited evidence that it can produce desired outcomes safely."
Is this trial restricted to people aged 65 and over?
"The lower limit of acceptance into this trial is 30 years old, while the upper threshold for eligibility caps at 80."
Is there any possibility for me to join this experiment?
"This research study is searching for 72 individuals between 30 and 80 years old who have been clinically diagnosed with osteoarthritis of the knee, as confirmed by American College of Rheumatology criteria. Other requirements include a BMI under 40 kg/m2, moderate pain in their index joint, having failed two or more types of conservative therapy for OA in the past, and active contraception use if sexually active. Written consent to participate is also mandatory."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Arizona Research Center: < 48 hours
Average response time
- < 2 Days
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