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

Trial Summary

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.

What data supports the effectiveness of the drug Triamcinolone Acetonide Extended Release Injection (Zilretta) for osteoarthritis?

Research shows that Triamcinolone Acetonide Extended Release Injection (Zilretta) significantly reduces knee osteoarthritis pain compared to a placebo. It also improves pain, stiffness, and physical function, and is generally well tolerated. ^{1 2 3 4 5}

Is Triamcinolone Acetonide Extended Release Injection safe for humans?

Triamcinolone Acetonide Extended Release Injection, also known as Zilretta, is generally well tolerated for knee osteoarthritis, with a safety profile similar to placebo and other forms of triamcinolone acetonide. It reduces systemic exposure, which lessens common steroid-related side effects like blood sugar spikes. However, other forms of triamcinolone acetonide used in different conditions, like tendinitis and eye diseases, have been associated with risks such as tendon damage and eye complications. ^{1 2 6 7 8}

What makes the drug Triamcinolone Acetonide Extended Release Injection unique for treating knee osteoarthritis?

Triamcinolone Acetonide Extended Release Injection is unique because it uses microspheres to slowly release the medication in the knee joint, providing longer-lasting pain relief and reducing side effects compared to standard treatments. ^{1 2 4 5 9}

What is the purpose of this trial?

The goal of this study is to investigate if a timed release steroid injection may be beneficial in treating carpometacarpal (CMC) joint (thumb) osteoarthritis. The main questions to be answered are: 1. does the steroid injection substantially reduce pain in the thumb 2. does the steroid injection help to increase thumb function Participants will be asked to undergo a thumb CMC joint injection and to attend follow up visits to assess pain and thumb function.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

2. United States 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. [2019]

3. England 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. [2022]

4. United States 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. [2019]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Can Platelet-Rich Plasma Protect Rat Achilles Tendons From the Deleterious Effects of Triamcinolone Acetonide? [2022]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Intravitreal injections of corticoids]. [2013]

8. England 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Physical and Chemical Compatibility of Extended-Release Triamcinolone Acetonide (TA-ER) with Common Local Anesthetics. [2020]