Trial reportArthritis research & therapy2022
TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study.
Trial report in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03005873 (A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients With Osteoarthritis (OA) of Knee
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Factors Contributing to Variability in Longitudinal Pain Scores in Osteoarthritis Randomised Clinical Trials: A Systematic Review and Meta-Analysis.European journal of pain (London, England) · 2026Pooled it
- Emerging therapies for knee osteoarthritis.Nature reviews. Rheumatology · 2026Review
- From molecular networks to the clinic: a systems biology-nanomedicine roadmap for osteoarthritis diagnosis, regeneration, and safety-by-design.Discover nano · 2026Review
- Advances in drug delivery systems for Osteoarthritis therapy: exosomes, microparticles, nanoparticles, and hydrogels.Discover nano · 2026Review
- Repurposing Denosumab for Knee Osteoarthritis: A Real-World Signal That Now Needs a Trial.International journal of rheumatic diseases · 2026Article
- Osteoarthritis: Epidemiology, Diagnosis, and Treatment.MedComm · 2026Review
- Pharmacokinetic and biodistribution (PK/BD) study of ProGel-Dex, a thermoresponsive dexamethasone prodrug for sustained joint pain relief in a mouse model of osteoarthritis.Nanomedicine : nanotechnology, biology, and medicine · 2026Article
- Nanotechnology-driven delivery of dexamethasone for arthritis: The role of liposomes.EXCLI journal · 2026Review
- Placebo response to intra-articular injections in knee osteoarthritis: magnitude, evolution over time, and influencing factors. A systematic review and meta-analysis with meta-regression.EFORT open reviews · 2025Article
- Panaxatriol exerts anti-senescence effects and alleviates osteoarthritis and cartilage repair fibrosis by targeting UFL1.Journal of advanced research · 2025Article
- Long-Acting Extracellular Vesicle-Based Biologics in Osteoarthritis Immunotherapy.Bioengineering (Basel, Switzerland) · 2025Review
- Liposome-Based Interventions in Knee Osteoarthritis.Small (Weinheim an der Bergstrasse, Germany) · 2025Review
- Therapeutic Controlled Release Strategies for Human Osteoarthritis.Advanced healthcare materials · 2025Review
- Osteoarthritis: multitissue pathology, molecular mechanisms, clinical management, and emerging precision and regenerative therapies.Frontiers in pharmacology · 2025Review
- The Challenges of Local Intra-Articular Therapy.Medicina (Kaunas, Lithuania) · 2024Review
- Lubricant Strategies in Osteoarthritis Treatment: Transitioning from Natural Lubricants to Drug Delivery Particles with Lubricant Properties.Journal of xenobiotics · 2024Review
- A Review of Current Approaches to Pain Management in Knee Osteoarthritis with a Focus on Italian Clinical Landscape.Journal of clinical medicine · 2024Review
- Single dose thermoresponsive dexamethasone prodrug completely mitigates joint pain for 15 weeks in a murine model of osteoarthritis.Nanomedicine : nanotechnology, biology, and medicine · 2024Article
- Knee osteoarthritis: disease burden, available treatments, and emerging options.Therapeutic advances in musculoskeletal disease · 2024Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCorticosteroid injection for knee osteoarthritis is limited by its modest duration of treatment effect. The liposome formulation of dexamethasone sodium phosphate (TLC599) was developed for the sustained relief of osteoarthritis pain. This clinical study was conducted to evaluate the efficacy and safety of TLC599 at two dose levels in patients with knee osteoarthritis.
methodsA randomized, double-blinded, placebo-controlled study was conducted in 75 patients with osteoarthritis of the knee from 13 study centers. Patients were randomized and administered a single intra-articular injection of TLC599 or placebo and assessed for efficacy and safety for 24 weeks. Patient-reported outcomes included the Western Ontario and McMaster Universities Arthritis (WOMAC) Index for pain and function and visual analog scale for pain.
resultsTLC599 at 12 mg demonstrated significantly greater reduction in WOMAC pain through 12 weeks (least squares (LS) mean difference = - 0.37, p = 0.0027) and through 24 weeks (LS mean difference = - 0.35, p = 0.0037) when compared to placebo. TLC599 12 mg also exhibited significantly greater improvement in function when compared to placebo at 24 weeks (LS mean difference = - 0.26, p = 0.0457). TLC599 18 mg did not significantly improve pain or function in comparison with placebo. The use of acetaminophen during the study was less in both TLC599 groups in comparison with placebo. No major or unexpected safety issues were reported.
conclusionsIn participants with symptomatic knee osteoarthritis, TLC599 is a well-tolerated treatment that reduces pain and improves function for up to 24 weeks, a longer duration than that reported for existing IA treatments.
trial registrationClinicalTrials.gov , NCT03005873 . Registered on 29 December 2016.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.