Steroid Injections for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Marie Badalamente

Must not be taking: Opioids, Over-the-counter pain

Disqualifiers: Pregnancy, Rheumatoid arthritis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special timed-release steroid injection can reduce pain and improve thumb function in individuals with osteoarthritis in the thumb joint. The main treatment tested is Triamcinolone Acetonide Extended Release Injection, compared to a placebo (a harmless shot with no active medicine). Suitable candidates have a confirmed case of thumb osteoarthritis and frequently experience significant thumb pain. Participants will receive an injection and attend follow-up visits to assess effectiveness. As a Phase 2 trial, this research measures the treatment's efficacy in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

You will need to stop taking opioid or over-the-counter pain medications during the study. This will be monitored and recorded in a log.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that triamcinolone acetonide extended-release injections are generally safe. In studies on osteoarthritis, most participants tolerated the injections well, with safety consistent across both older and younger patients.

This treatment releases the steroid slowly, resulting in lower levels of the drug entering the bloodstream at once, which can reduce the risk of side effects. Some participants experienced minor side effects, such as soreness at the injection site, but these were usually mild.

The FDA has already approved triamcinolone acetonide for treating knee osteoarthritis, indicating its relative safety. However, since this trial is in an early stage, researchers are still assessing its safety for treating thumb osteoarthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Most treatments for osteoarthritis, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and standard corticosteroid injections, provide temporary relief by reducing inflammation. However, Triamcinolone Acetonide Extended Release Injection is unique because it offers an extended release formulation. This means it can provide longer-lasting pain relief compared to traditional steroid injections, potentially reducing the need for frequent treatments. Researchers are excited about this treatment because it targets inflammation over a more extended period, which could improve patient comfort and compliance with fewer injections.

What evidence suggests that this treatment might be an effective treatment for osteoarthritis?

Research has shown that triamcinolone acetonide extended-release injections, which participants in this trial may receive, can effectively reduce pain. In other studies, patients with osteoarthritis who received these injections in their joints experienced pain relief for 5–6 months. This treatment often provides quick pain relief, starting in just four days. Additionally, it can improve physical abilities, such as standing up from a chair, for up to 12 weeks after the injection. These findings suggest that this injection might help reduce thumb pain and improve function for those with thumb joint osteoarthritis. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with X-ray confirmed thumb osteoarthritis (Eaton stages I-III) and significant pain can join this study. They must not take opioids or OTC pain meds during the trial, avoid pregnancy, and have no history of severe reactions to the drug being tested or similar drugs.

Inclusion Criteria

My X-ray shows I have early to moderate thumb arthritis.

My thumb pain is rated 5 or higher on a pain scale.

Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria

I am not pregnant, nursing, planning to become pregnant, or unwilling to use birth control during the study.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Known or suspected hypersensitivity to TA-ER (or component of TA-ER), triamcinolone acetonide

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Triamcinolone acetonide extended-release or saline placebo injection in the CMC joint

12 weeks

1 visit (in-person) for injection

Follow-up

Participants are monitored for pain reduction and thumb function improvement

6 months

Multiple visits (in-person) over 12 weeks and one visit at 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide Extended Release Injection

Trial Overview The trial is testing if a timed-release steroid injection reduces thumb pain and improves function in patients with thumb osteoarthritis. Participants will receive an injection in their thumb joint and attend follow-ups to assess changes in pain and movement.

How Is the Trial Designed?

Group I: Triamcinolone acetonide extended release suspension injection Experimental Treatment 1 Intervention

Active drug treatment

Group II: Saline Placebo Injection Placebo Group 1 Intervention

Placebo comparator

Triamcinolone Acetonide Extended Release Injection is already approved in United States for the following indications:

Approved in United States as Zilretta for:

• Osteoarthritis pain of the knee

Who Is Running the Clinical Trial?

Marie Badalamente

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Intravitreal injections of triamcinolone acetonide are commonly used to treat various eye diseases, but they carry risks of significant complications such as increased intraocular pressure, cataracts, and retinal detachment.

Due to the potential for toxicity and complications, careful consideration and monitoring are essential when performing these injections to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intravitreal injections of corticoids]. Demols, P.[2013]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

In a Phase-3 study involving 484 adults with knee osteoarthritis, FX006 (32 mg) significantly reduced average daily pain intensity compared to saline placebo, achieving about a 50% improvement by week 12.

FX006 also showed favorable results in secondary and exploratory measures of osteoarthritis symptoms compared to placebo, while its efficacy was similar to that of standard triamcinolone acetonide (TAcs) in terms of pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. Conaghan, PG., Hunter, DJ., Cohen, SB., et al.[2019]

In a study involving rat Achilles tendons, the addition of platelet-rich plasma (PRP) to triamcinolone acetonide (TA) injections significantly prevented the negative effects of TA, such as reduced tendon strength and stiffness, which were observed in the TA-only group.

Histological analysis showed that PRP administration prevented harmful changes in tendon structure caused by TA, suggesting that PRP could serve as a protective agent for patients receiving corticosteroid injections for sports injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Platelet-Rich Plasma Protect Rat Achilles Tendons From the Deleterious Effects of Triamcinolone Acetonide? Muto, T., Kokubu, T., Mifune, Y., et al.[2022]

FX006, a new extended-release formulation of triamcinolone acetonide, did not meet the primary endpoint of significantly reducing knee pain compared to saline placebo at week 12, but showed greater pain relief at earlier weeks (1-11) and a longer duration of effect with higher doses.

Both doses of FX006 (32 mg and 16 mg) were well tolerated, indicating a safety profile similar to that of saline placebo, suggesting that FX006 could be a viable treatment option for managing osteoarthritis pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Conaghan, PG., Cohen, SB., Berenbaum, F., et al.[2019]

The study found that combining local anesthetics (lidocaine, ropivacaine, and bupivacaine) with the novel triamcinolone acetonide extended-release (TA-ER) formulation does not negatively affect its physical or chemical properties, ensuring its efficacy remains intact.

This compatibility suggests that in clinical practice, local anesthetics can be safely added to TA-ER injections for knee osteoarthritis pain without compromising the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. Jackson, JD., Cotton, L., Turkington, M., et al.[2020]

In a study involving 30 patients with hip osteoarthritis, the extended-release formulation of triamcinolone acetonide (TA-ER) was found to have a comparable safety profile to the conventional crystalline suspension (TAcs), with fewer treatment-emergent adverse events (TEAEs) reported (26.7% for TA-ER vs. 46.7% for TAcs).

TA-ER resulted in significantly lower peak plasma concentrations and overall systemic exposure compared to TAcs, suggesting a potentially safer profile with gradual elimination from the body, which may reduce the risk of systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Kivitz, A., Mehra, P., Hanson, P., et al.[2022]

A single intra-articular injection of triamcinolone acetonide extended-release (TA-ER) showed prolonged presence in the joint compared to the standard crystalline suspension, indicating its potential for sustained therapeutic effects in knee osteoarthritis.

The study found that while TA-ER and the crystalline form had similar mild effects on cartilage, the transient nature of these effects suggests that TA-ER's benefits may be more pronounced in diseased joints rather than in healthy ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Effects Following Single and Repeat Intra-Articular Injections of Triamcinolone Acetonide Extended-Release: Results from Three Nonclinical Toxicity Studies in Dogs. Bodick, N., Williamson, T., Strand, V., et al.[2020]

In a phase 3b study involving 208 patients with knee osteoarthritis, repeat injections of triamcinolone acetonide extended-release (TA-ER) were found to be safe and well tolerated, with no unexpected adverse events or significant changes in knee radiographs after 52 weeks.

Both the first and second injections of TA-ER provided similar and substantial pain relief, with most patients experiencing at least a 50% reduction in pain, indicating effective symptom management across varying severities of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Spitzer, AI., Richmond, JC., Kraus, VB., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824457/

Efficacy of Triamcinolone Acetonide Extended-Release in ... TA-ER provided 5–6 months' pain relief that consistently exceeded saline-placebo and TAcs, suggesting that TA-ER injected intra-articularly into the affected ...

2. zilrettapro.com zilrettapro.com/efficacy

ZILRETTA® Efficacy Data | Clinical Trial Results Rapid, persistent, and proven relief from OA knee pain · Rapid—4 days median time to onset with ZILRETTA® (triamcinolone acetonide extended-release injectable ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S266591312200036X

The effect of intra-articular extended-release triamcinolone ... These data indicate improvement in chair stand performance through 12 weeks post-injection and sustained improvement in participant-reported physical function ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04261049

Study Details | NCT04261049 | Effect of Zilretta Injection The ZILRETTA knee injection is an FDA approved, extended release corticosteroid for in patients with knee osteoarthritis and has been shown to reduced knee pain ...

5. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/ne/Pharmacy/Zilretta_triamcinolone-acetonide-ER-injection_C16855-A.ashx

Zilretta (triamcinolone acetonide ER injection) C16855-A A single IA injection of extended-release TAA (Zilretta) can relieve moderate to severe OA knee pain and appears to be well tolerated; however, ...

6. zilrettapro.com zilrettapro.com/safety-data

ZILRETTA® Safety Profile | Tolerability Data for HCPs Safety profile and tolerability data from ZILRETTA clinical studies. Adverse event information for healthcare professional review.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363704/

Safety and Systemic Exposure of Triamcinolone Acetonide ... These pharmacokinetic data confirm protracted release of TA from TA-ER following IA injection in patients with shoulder OA. Lower peak and systemic TA exposure ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/208845s000lbl.pdf

Reference ID: 4163229 FDA Label Not Latest No overall differences in safety or effectiveness were observed between elderly and younger subjects, and other reported clinical experience with triamcinolone ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9718335/

The effect of intra-articular extended-release triamcinolone ... These data indicate improvement in chair stand performance through 12 weeks post-injection and sustained improvement in participant-reported physical function.