A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in … (NCT05337540) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee
Brazil120 participantsStarted 2024-01-17
Plain-language summary
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients of both genders aged 18 years or older;
. Body Mass Index (BMI) \< 35 kg/m2;
. Diagnosis of primary knee osteoarthritis, Kellgren-Lawrence Grade 2 to 4, according to American College of Rheumatology (ACR) criteria and confirmed radiologically within the previous 12 months, for which an intraarticular treatment is indicated;
. Moderate to severe pain measured by VAS (0-100mm) and \>40mm in the knee to be treated, partially responsive to chronic doses of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or weak opioids (codeine and tramadol);
. Ability to understand and provide signed consent through the Informed Consent Form (ICF).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
Timeframe: from baseline to 180 days after randomization
2
Comparison of treatment-related Adverse Events in the three groups
Timeframe: from baseline to 180 days after randomization
. History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;
. Pregnant or breastfeeding women;
. Women at menace who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, IUD, hormonal implant, barrier methods, sexual abstinence, hormone transdermal patch and tubal ligation); except those who are surgically sterile (bilateral oophorectomy or hysterectomy);
. Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;
. Application of visco-supplementation to the knee less than four months prior to randomization;
. Corticosteroid IA injection less than 4 months prior to randomization and/or schedule during the course of the study;
. Knee infection and/or inflammation (e.g., bursitis), skin infection at or around the IA injection;
. Swelling, redness, warmth, or other clinically relevant inflammatory signs in the knee in the investigator's description