WHO ICTRP trial

To study efficacy, safety and tolerability of intra-artecular regimens of LNA043…

CTRI/2021/10/037098 · Clinical Trials Registry India (CTRI) · Recruiting

Key facts

Trial ID CTRI/2021/10/037098
Public title To study efficacy, safety and tolerability of intra-artecular regimens of LNA043 versus placebo in adult patients with symptomatic knee osteoarthritis
Scientific title 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) - ONWARDS
Primary sponsor Novartis Healthcare Pvt Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Recruiting
Study type Interventional
Phase Phase 2
Countries Argentina;Australia;Austria;Canada;China;Czech Republic;Denmark;Estonia;Germany;Hungary;India;Japan;Lithuania;Mexico;Poland;Spain;Taiwan;United Kingdom;United States of America
Conditions Health Condition 1: M179- Osteoarthritis of knee, unspecified
Interventions Intervention1: LNA043: LNA043 in different doses (20 mg and 40 mg), number of injections in a cycle (1 vs 3) and dosing cycle frequency (every 6 months vs every 12 months) Control Intervention1: Placebo: Saline solution
Registration date May 10, 2021
Target size 550
Secondary IDs 2020-004897-22;CLNA043A12202 Version 0.0 dated 23 Feb 2021;NCT04864392
Registry page ctri.nic.in

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