NCT02471118

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: CARE ARTHRITIS LTD. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Adalimumab 40 mg	Adalimumab will be self-administered via subcutaneous (SC) injection
DRUG	Placebo	Placebo will be self-administered via subcutaneous (SC) injection

Timeline

• Start date: 2015-03-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2015-06-15
• Last updated: 2021-10-27

Locations

7 sites across 1 country: Canada