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

Sponsor
CARE ARTHRITIS LTD.
Study ID
NCT02471118
Phase
PHASE2
Status
Completed

Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab 40 mg — DRUG
    Adalimumab will be self-administered via subcutaneous (SC) injection
  • Placebo — DRUG
    Placebo will be self-administered via subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date
Mar 31, 2015
Status verified
Oct 2021
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 1st 50 subjects to Enter the Study
    At Baseline, subjects will be randomized (1:1) to receive study drug (Adalimumab or placebo). The study drug will be provided as a subcutaneous injection (pre-filled syringe) either Adalimumab (ADA) 40 mg/0.8 mL,every other week (EOW) or matching placebo for Adalimumab every other week for 16 weeks. 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 ADA 40 mg EOW and will continue to receive open label ADA up to Week 50. An End of Study visit will be done at Week 52. A Telephone Follow-up will be done at Week 62 to review Adverse Events and Concomitant Medications.
  • Experimental: 2nd group of 50 subjects
    At Baseline, subjects will be randomized (1:1) to receive either adalimumab 40 mg every other week or placebo for 16 weeks. All subjects will begin to receive open label adalimumab 40 mg every other week from week 16-week 30, with An End of Study visit at Week 32. A Telephone Follow-up will be done at Week 42 to review Adverse Events and Concomitant Medications.

Primary Outcome Measure

Primary Endpoint: the percentage of subjects achieving an Osteoarthritis Research Society International/Outcome Measures in Rheumatology Clinical trials (OARSI/OMERACT) response at Week 16 [ Time Frame: 16 weeks ]

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