A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis




Henning Bliddal (principal investigator), Signe Rifbjerg-Madsen, Anton W Christensen, Bjarke B Hansen, Mikael Boesen




Joints with osteoarthritis are characterized by inflammation in many instances. The inflammation may cause tissue damage, while also be a major contributor to the clinical problems with the joint, especially pain. Over the years, joints with inflammation have been treated with injection of glucocorticosteroids to deal with this problem. This treatment, however, is not a lasting solution to the inflammation and there is a demand for other medications with anti-inflammatory properties. In this project, subjects with defined signs of inflammation in the osteoarthritic knee joint will be enrolled in a RCT. Test drug is acting on Il-1 and the effect will be followed both clinically and by imaging, in this case dynamic contrast enhanced MRI. The randomization has 4 arms with one placebo and three active, with a distribution 1:2:2:2. The test medication is given as injection every 2 weeks for a year.

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