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Corticosteroid

Triamcinolone Acetonide for Knee Osteoarthritis in Type 2 Diabetes

Phase 4

Recruiting

Led By Neil A Segal, MD, MS

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥40 years of age

Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2 (in past 8 weeks)

Must not have

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease

History of infection in the index knee joint

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to time periods of 0 to 24 hours (days 1-2); 0 to 48 hours (days 1- 3); and 0 to 72 hours (days 1-4), for zilretta relative to tca-ir. diabetes symptom checklist - revised (dsc-r) is scored from a low of 1 to a high of 5.

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

"This trial will compare the effects of two different forms of triamcinolone acetonide on blood glucose levels in diabetic patients with knee osteoarthritis. The study will last approximately 4

Who is the study for?

This trial is for people with Type 2 Diabetes (with HbA1C ≤9, not on insulin) and painful knee osteoarthritis. Participants should have a stable management plan for diabetes and meet specific clinical and radiological criteria to confirm their arthritis diagnosis.

What is being tested?

The study compares two treatments: Zilretta (an extended-release steroid injection) versus Kenalog (an immediate-release steroid injection), focusing on how they affect blood sugar levels in diabetic patients with knee osteoarthritis over approximately four months.

What are the potential side effects?

Possible side effects include elevated blood sugar levels, pain at the injection site, allergic reactions, increased risk of infection, changes in appetite, mood swings, and potential impact on adrenal gland function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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My kidney function test shows an eGFR of 50 mL/min/1.73 m2 or higher.

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I have been diagnosed with osteoarthritis according to specific criteria.

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I am willing to wear a CGM device all day every day and follow its use instructions during the study.

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I have had knee pain from arthritis for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a type of arthritis linked to inflammation or bowel disease.

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I have had an infection in my knee before.

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I have moderate or severe issues with my kidney, liver, or thyroid.

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I have glaucoma.

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My cancer is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to time periods of 0 to 24 hours (days 1-2); 0 to 48 hours (days 1- 3); and 0 to 72 hours (days 1-4), for zilretta relative to tca-ir. diabetes symptom checklist - revised (dsc-r) is scored from a low of 1 to a high of 5.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to time periods of 0 to 24 hours (days 1-2); 0 to 48 hours (days 1- 3); and 0 to 72 hours (days 1-4), for zilretta relative to tca-ir. diabetes symptom checklist - revised (dsc-r) is scored from a low of 1 to a high of 5.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to time periods of 0 to 24 hours (days 1-2); 0 to 48 hours (days 1- 3); and 0 to 72 hours (days 1-4), for zilretta relative to tca-ir. diabetes symptom checklist - revised (dsc-r) is scored from a low of 1 to a high of 5. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of time spent with blood glucose >180 mg/dL

Secondary study objectives

Area under the curve (AUC) for cortisol levels

Change in 40m walk time

Change in patient-reported physical function (KOOS-PS)

+4 more

Other study objectives

Change in Average Daily Pain

Change in worst daily knee pain intensity

Effect of hyperglycemia on cognition

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: TA-IRActive Control1 Intervention

Name: Kenalog®-40 (triamcinolone acetonide injectable suspension) Active Ingredient: Triamcinolone Acetonide- Immediate Release (TA-IR) Dosage: 40 mg/mL, IA, administered as a 1 mL Injection: TA-IR Mode of Administration: IA Knee Injection

Group II: TA-ERActive Control1 Intervention

Name: ZILRETTA (triamcinolone acetonide extended-release injectable suspension; TA-ER) Active ingredient: Extended-release formulation of TA in 75:25 poly (lactic-co-glycolic) acid (PLGA) microspheres Dosage: Nominal 32 mg TA, intra-articular (IA) injection, administered as a 5 mL injection Mode of Administration: IA Knee Injection

0 / 10Eligibility criteria met