Extensive evidence in knee osteoarthritis
Cingal’s clinical foundation is built on multiple Phase III randomised, controlled clinical trials conducted in patients with knee osteoarthritis.
Pivotal Trial at a Glance: Study 13-01
| Design | Randomised, double-blind, multicentre Phase III |
|---|---|
| Patients | 368 |
| Population | Knee OA, KL Grades I–III |
| Follow-up | 26 weeks |
| Primary endpoint | WOMAC pain score |
| Comparators | HA alone · Saline |
| Reference | Hangody et al., Cartilage 2018 |
A multicentre trial showed consistent improvement across all outcomes
The pivotal Phase III study (368 patients, KL grades I-III) compared Cingal against saline, HA alone, and TH alone over 26 weeks. Results demonstrated statistically significant improvements in pain, stiffness, and physical function from as early as Week 1.
The WOMAC composite scale captured improvements across pain, stiffness, and physical function: the three domains most relevant to patient quality of life in knee OA.
Study Profile: Cingal 13-01
- Randomised, double-blind, placebo-controlled
- 368 patients enrolled
- Knee OA, Kellgren-Lawrence Grades I–III
- Primary endpoint: WOMAC pain at 26 weeks
- Secondary endpoint: OMERACT-OARSI responder rate
- Follow-up: 26 weeks
Rapid Onset of Pain Relief
Significant improvement in pain scores observed as early as Week 1, with faster onset of relief compared with hyaluronic acid alone, a clinically meaningful differentiation for patients awaiting symptom control.
WOMAC Pain Improvement
Improvement in WOMAC pain score at 26 weeks. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is the validated, patient-reported outcome measure for OA pain, stiffness, and physical function.
OMERACT-OARSI Responders at 26 Weeks
OMERACT-OARSI is the validated responder criteria for OA clinical trials. A 92% responder rate at 26 weeks demonstrates both durable response and high patient-level clinical relevance.
Measured Time Points vs. Saline
Cingal demonstrated superiority versus saline control at measured time points across the 26-week follow-up period, confirming consistent and sustained efficacy beyond placebo.
Clinical outcome charts
The following charts illustrate the efficacy outcomes from the pivotal Phase III trial (Study 13-01).
- Hangody L, et al. Intraarticular injection of a cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal) to provide symptomatic relief of osteoarthritis of the knee: a randomized, double-blind, placebo-controlled multicenter clinical trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. PMID: 28535076; PMCID: PMC6042027. https://pmc.ncbi.nlm.nih.gov/articles/PMC6042027/(opens in a new tab)
- Data on File 16-02.
- Data on File 19-01.
- All charts: Hangody L, et al. Intraarticular injection of a cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal) to provide symptomatic relief of osteoarthritis of the knee: a randomized, double-blind, placebo-controlled multicenter clinical trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. PMID: 28535076; PMCID: PMC6042027. pmc.ncbi.nlm.nih.gov/articles/PMC6042027(opens in a new tab)
