SI-613 Study for Knee Osteoarthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Combination product: SI-613; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Florida
    • Miami, Florida, United States, 33185
      • MM Medical Center, Inc.
    • Miami, Florida, United States, 33186
      • Quality Research and Medical Center, LLC
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provides their written informed consent.
• Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
• Is willing to switch to using acetaminophen as a rescue medication

Exclusion Criteria:

• Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
• Secondary OA
• Is a female subject who is pregnant or lactating.
• Is currently hospitalized or has a planned hospitalization during the life of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Combination product: Placebo; Placebo will be repeated intra-articularly administered.
EXPERIMENTAL: SI-613	Combination product: SI-613; SI-613 will be repeated intra-articularly administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks	Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.	Baseline over 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.	Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.	Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26	Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.	Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Total Score at Weeks 12 and 26	WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.	Baseline, Weeks 12 and 26

Collaborators and Investigators

• Sponsor: Seikagaku Corporation
• Collaborators: Chiltern International Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2017
• Primary Completion (ACTUAL): August 17, 2018
• Study Completion (ACTUAL): November 13, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Intra-articular injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 613 /1121

Drug and device information, study documents

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