BridgeMD
Tests treatment safety and results for Osteoarthritis
Official title An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
ClinicalTrials.gov ID: NCT06485843
What this study is testing
What is OA-SYS?
OA-SYS is an investigational medicine, being studied as a potential treatment for osteoarthritis.
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 study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
- Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment
- Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee
You likely can't join if
- Known or suspected infection of the target joint
- people with surgery for OA in the target joint
- Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel...
- Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension)...
- Subject with serious medical conditions other than cardiovascular disease
- Subject with, or with a medical history of autoimmune diseases
See the full eligibility criteria
- Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
- Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment
- Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee
- No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments
- For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method till end of the study period and negative pregnancy test
- For males of reproductive potential: use of condoms and other methods to ensure effective contraception
- Known or suspected infection of the target joint
- people with surgery for OA in the target joint
- Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90 mmHg even with treatment with more...
- Subject with serious medical conditions other than cardiovascular disease
- Subject with, or with a medical history of autoimmune diseases
- Subject with an infection that requires parenteral antibiotic administration within 30 days prior to screening
- Subject with a medical history of mental disorder or epilepsy
- Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
- Subject who was diagnosed with cancer within 5 years before screening
- Subject who participated in another clinical trial within 6 months prior to the screening of this clinical trial
- Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening
- Subject who had intra-articular administration such as sodium hyaluronate injections within 6 months prior to the screening
- Clinical findings consistent with active infection or crystal disease in the index joint within 1 month prior to the screening
- History of fracture in the index limb or fracture with sequelae within 12 months prior to the screening
- Joint instability or history of acute dislocation within 12 months prior to the screening
- Planned or anticipated surgery of the joint during the study period
- Presence of surgical hardware or other foreign body in the index joint
- Surgery or arthroscopy of the index joint within 12 months of screening
- Intra-articular treatment of any joint with any of the following agents within 6 months prior to the screening: Any corticosteroid preparation (investigational or marketed), any biologic agent (e.g., platelet rich...
- Treatment of the index joint with any investigational therapy within 6 months prior to the screening
- Serious life-threatening conditions
- Allergies to anesthesia
- Subject who is breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Las Vegas, Nevada, 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, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Vegas, Nevada, 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.