Clinical trial NCT02951026: An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
Official title: A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: knee
osteoarthritis
intra-articular injection
SM04690
Lead sponsor: Biosplice Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 703
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2 or phase 3 study.

Brief summary: This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.


Eligibility criteria: Inclusion Criteria:

* Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
* Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
* Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

* Unable to undergo the radiograph procedures detailed within the protocol
* Partial or complete joint replacement in the target knee
* Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
* Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Primary outcomes:
measure: Incidence rate of serious adverse events (SAEs)
timeFrame: Month 60
Secondary outcomes:
measure: Adverse events (AEs) of interest
timeFrame: Month 6
measure: AEs of interest
timeFrame: Month 12
measure: AEs of interest
timeFrame: Month 24
measure: AEs of interest
timeFrame: Month 36
measure: AEs of interest
timeFrame: Month 48
measure: AEs of interest
timeFrame: Month 60
measure: Incidence and incidence rate of total knee replacement (TKR)
timeFrame: Month 60
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 6
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 12
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 24
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 36
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 48
measure: Change in joint space width (JSW)
timeFrame: Baseline and Month 60
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score
timeFrame: Baseline and Month 6
measure: Change in WOMAC total score
timeFrame: Baseline and Month 12
measure: Change in WOMAC total score
timeFrame: Baseline and Month 24
measure: Change in WOMAC total score
timeFrame: Baseline and Month 36
measure: Change in WOMAC total score
timeFrame: Baseline and Month 48
measure: Change in WOMAC total score
timeFrame: Baseline and Month 60
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 6
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 12
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 24
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 36
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 48
measure: Change in WOMAC pain subscore
timeFrame: Baseline and Month 60
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 6
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 12
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 24
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 36
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 48
measure: Change in WOMAC function subscore
timeFrame: Baseline and Month 60
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 6
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 12
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 24
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 36
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 48
measure: Change in Physician Global Assessment
timeFrame: Baseline and Month 60
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 6
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 12
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 24
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 36
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 48
measure: Change in Patient Global Assessment
timeFrame: Baseline and Month 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Oro Valley
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Canoga Park
country: United States
facility: Research Site
state: California
city: Carmichael
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: El Cajon
country: United States
facility: Research Site
state: California
city: Gold River
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Marcos
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Trumbull
country: United States
facility: Research Site
state: Connecticut
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Edgewater
country: United States
facility: Research Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Woodstock
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Newton
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Peters
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Orchard Park
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: High Point
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Bedford
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Angelo
country: United States
facility: Research Site
state: Texas
city: Layton
country: United States
facility: Research Site
state: Utah
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Biosplice Therapeutics, Inc.
name: Yusuf Yazici, M.D.
role: STUDY_DIRECTOR
References: