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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951026
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Tracking Information
First Submitted Date October 7, 2016
First Posted Date November 1, 2016
Last Update Posted Date April 4, 2019
Study Start Date September 2016
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2016)
Incidence rate of serious adverse events (SAEs) [ Time Frame: Month 60 ]
Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 28, 2016)
  • Adverse events (AEs) of interest [ Time Frame: Month 6 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 6. AEs of interest include those related to either knee and/or an AE that is a newly diagnosed chronic condition requiring treatment (e.g., hypertension, hyperlipidemia, diabetes).
  • AEs of interest [ Time Frame: Month 12 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 12.
  • AEs of interest [ Time Frame: Month 24 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 24.
  • AEs of interest [ Time Frame: Month 36 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 36.
  • AEs of interest [ Time Frame: Month 48 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 48.
  • AEs of interest [ Time Frame: Month 60 ]
    Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 60.
  • Incidence and incidence rate of total knee replacement (TKR) [ Time Frame: Month 60 ]
    Compare the incidence and incidence rate of TKR in the previously injected knee occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 6 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 12 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 24 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 36 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 48 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in joint space width (JSW) [ Time Frame: Baseline and Month 60 ]
    Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score [ Time Frame: Baseline and Month 6 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in WOMAC total score [ Time Frame: Baseline and Month 12 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in WOMAC total score [ Time Frame: Baseline and Month 24 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in WOMAC total score [ Time Frame: Baseline and Month 36 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in WOMAC total score [ Time Frame: Baseline and Month 48 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in WOMAC total score [ Time Frame: Baseline and Month 60 ]
    Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 6 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 12 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 24 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 36 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 48 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in WOMAC pain subscore [ Time Frame: Baseline and Month 60 ]
    Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 6 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 12 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 24 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 36 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 48 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in WOMAC function subscore [ Time Frame: Baseline and Month 60 ]
    Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 6 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 12 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 24 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 36 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 48 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in Physician Global Assessment [ Time Frame: Baseline and Month 60 ]
    Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 6 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 12 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 24 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 36 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 48 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48.
  • Change in Patient Global Assessment [ Time Frame: Baseline and Month 60 ]
    Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Osteoarthritis
Intervention Other: Not applicable (no therapy is administered as part of this study)
No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study.
Study Groups/Cohorts
  • 0.03mg SM04690 (previously injected)
    Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
    Intervention: Other: Not applicable (no therapy is administered as part of this study)
  • 0.07mg SM04690 (previously injected)
    Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
    Intervention: Other: Not applicable (no therapy is administered as part of this study)
  • 0.23mg SM04690 (previously injected)
    Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
    Intervention: Other: Not applicable (no therapy is administered as part of this study)
  • Placebo (previously injected)
    Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study.
    Intervention: Other: Not applicable (no therapy is administered as part of this study)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 28, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02951026
Other Study ID Numbers SM04690-OA-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Samumed LLC
Study Sponsor Samumed LLC
Collaborators Not Provided
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC
PRS Account Samumed LLC
Verification Date April 2019