Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA) — OKINADA  

Osteoarthritis, Knee Clinical Trial

Official title: Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA): A Randomized Placebo-controlled Trial

Status Completed

Clinical Trial Summary

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite receiving maximum tolerated doses of conventional therapy.

Clinical Trial Description

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite receiving maximum tolerated doses of conventional therapy. A total of 100 subjects will be entered into the study.

Subjects will be randomized (1:1) at baseline to receive either adalimumab 40 mg every other week or placebo for 16 weeks. The study drug will be self-administered via subcutaneous injection. Efficacy will be assessed at week 16 while the safety of the study drug will be monitored throughout the study. At week 16 all subjects will begin to receive open label adalimumab 40 mg every other week. ;

Related Conditions & MeSH terms

• Inflammation
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT02471118
• Study type: Interventional
• Source: Canadian Research & Education in Arthritis
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Completion date: March 2021