Sinomenine Versus Glucocorticoid for Knee OA

Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial

Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Sinomenine; Drug: Glucocorticoid

• Study Type: Interventional
• Enrollment (Anticipated): 328
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 40 and <70.
2. Bilateral knee pain lasting for more than 6 months and most of the last month;
3. X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.

Exclusion Criteria:

1. Kellgren and Lawrence Level 1 or 4.
2. Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
3. The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
4. Have had knee surgery or plan to have joint surgery on the affected knee.
5. Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.
6. Have a needle phobia.
7. Immunosuppression or acute infection is present.
8. Patients are allergic to the drugs involved in the study.
9. Have or have had cancer or tumours.
10. Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
11. History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides >2.3mmol/L
12. Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
13. Pregnancy.
14. Body mass Index (BMI) > 40 kg/m2.
15. Unable to attend all study appointments within 24 months;
16. Inability to understand written and spoken Chinese.
17. Any history of mental and psychological illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinomenine	Drug: Sinomenine; Participants will receive one intra-articular injection every 4 months
Active Comparator: Glucocorticoid	Drug: Glucocorticoid; Participants will receive one intra-articular injection every 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total WOMAC score and tibial cartilage volume	24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.	24 months after the first injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Timed Up and Go and 20m walking time	24 months after the first injection (1) the change in time from baseline in The Timed Up and Go (TUG) test and whether sinomenine was noninferior to glucocorticoid, and (2) the change in time spent at 20m walking time from baseline was and whether sinomenine was noninferior to glucocorticoid.	24 months after the first injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone marrow lesion (BML)	12 and 24 months after the first injection, to evaluate bone marrow lesion (BML) size of patients and whether sinomenine was noninferior to glucocorticoid.	12 and 24 months after the first injection

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2023
• Primary Completion (Anticipated): February 27, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Antirheumatic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sinomenine; Glucocorticoids
• Other Study ID Numbers: 2021-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No