BridgeMD
New treatment option for Osteoarthritis, Knee
Official title Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
ClinicalTrials.gov ID: NCT06478186
What this study is testing
What is triamcinolone acetonide extended-release injectable suspension; TCA-ER?
triamcinolone acetonide extended-release injectable suspension; TCA-ER is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
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
- A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis.
- 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 40 and older
You may be able to join if
- 1\. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to...
- Knee pain
- At least 1 of the following:
- Stiffness \<30 minutes
- Crepitus
You likely can't join if
- Disease-related Criteria
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- History of infection in the index knee joint.
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.
- Presence of surgical hardware or other foreign body in the index knee.
- Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.
See the full eligibility criteria
- 1\. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. 3\. Male or female ≥40 years of...
- Knee pain
- At least 1 of the following:
- Stiffness \<30 minutes
- Crepitus
- Osteophytes 12. Index knee pain more than 15 days over the last month (as reported by the subject). 13\. Kellgren-Lawrence Grade 2-4. 14. Willingness to wear a CGM device uninterrupted for 24 hours per day throughout...
- Disease-related Criteria
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.
- History of infection in the index knee joint.
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.
- Presence of surgical hardware or other foreign body in the index knee.
- Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.
- Moderate or severe kidney, liver, or thyroid disease.
- Glaucoma.
- Active cancer. Previous or Concomitant Treatment-related Criteria
- IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening.
- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening.
- IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening.
- Oral corticosteroids (investigational or marketed) within 1 month of Screening.
- Inhaled, intranasal, or topical corticosteroids (investigational or marketed) within 2 weeks of Screening.
- Any other IA investigational device, drug/biologic within 6 months of Screening or 5 half-lives (whichever is longer).
- Prior arthroscopic or open surgery of the index knee within 12 months of Screening.
- Planned/anticipated surgery of the index knee or any other surgery during the study period.
- Use of acetaminophen, or acetaminophen-containing products, from Screening through Day 14 (completion of post-treatment BG monitoring).
- people on Coumadins with INR ≥5 will be excluded (Bashir et al, 2015) Subject-related Criteria
- Known hypersensitivity to any form of triamcinolone.
- History of sarcoidosis or amyloidosis.
- Active or history of malignancy within the last 3 years, except for resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma.
- Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral, or parasitic infections or ocular herpes simplex.
- Any infection requiring IV antibiotics within 4 weeks of Screening or infection requiring oral antibiotics within 2 weeks of Screening.
- History of osteomyelitis.
- Known or clinically suspected infection with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
- Requiring or likely to require treatment with corticosteroids during the study period based on subject medical history.
- History or active Cushing's or Addison's syndrome.
- Active substance abuse (drugs or alcohol), history of chronic substance abuse within the last year, or prior chronic substance abuse judged by the Investigator likely to recur during the study.
- Skin breakdown at the knee where the injection would take place.
- Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 2 years of Screening.
- Receipt of a live or live attenuated vaccine within 3 months of Screening.
- Any other clinically significant psychiatric acute or chronic medical conditions that, in the judgment of the Investigator, would preclude the use of an IA corticosteroid or NSAIDs or that could compromise subject...
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, 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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, 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.