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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (no therapy is administered as part of this study)

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

Sponsors and collaborators

Lead sponsor

Biosplice Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2016
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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