A 5-year, randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS)

  • STATUS
    Recruiting
  • days left to enroll
    30
  • sponsor
    Novartis Research and Development
Updated on 3 September 2021
knee pain

Summary

A 5-year study, assessing the efficacy and safety of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS).

Description


Details
Condition Osteoarthritis
Clinical Study IdentifierTX281592
SponsorNovartis Research and Development
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

K/L 2-3
Hx of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month

Exclusion Criteria

Hx of anticoagulants that would preclude knee injection.Novel anticoagulants before IA inj. should be assessed by the treating physician
No hx of aspiration to target knee <12 wk prior to screening
No hx of arthroscopy <6 Mo. prior to screening
Hx of PRP/Stem Cell Therapy <26 wks prior to screening
Hx of Hyaluronians and/or Corticosteroids to target knee <12 wks prior to screening
Hx of centrally acting analgesics unless on a stable dose during core period
Hx of anticonvulsants unless used for seizure and on stable dose during core period
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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