Phase 2a Study Evaluating ABT-981 in Patients with Knee Osteoarthritis
Research type
Research Study
Full title
A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis
IRAS ID
150925
Contact name
Andrew Ostor
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2013-003467-60
Research summary
This study will assess the test compound ABT-981 in patients who have osteoarthritis of the knee. The purpose of the study is to see how safe and well tolerated ABT-981 is in this patient group and to find out if the compound reduces the discomfort associated with Osteoarthritis (this reflects the clinical endpoints) and worsening of the disease (this reflects the structure endpoints).
Osteoarthritis is the most common form of arthritis and it is relevant in the UK as more than 25 percent of the population aged 50 years or over have the disorder. This research is important as osteoarthritis causes significant pain and immobility that impacts on the ability of people to work, to live independently, and it increases the demand on health care services.
ABT-981 is currently being tested by AbbVie for the treatment of knee osteoarthritis and it works by targeting factors that cause inflammation and damage to the knee joint. Patients with osteoarthritis of the knee aged between 35 and 74 may be eligible for the study. Whilst taking the treatment patients may experience a reduction in pain and swelling and have improved mobility.
Patients would be required to attend regular study visits in order to receive treatment and to have safety checks such as blood tests and physical examinations. Treatment is in the form of an injection and this would be given at the study visit. Patients will receive either ABT-981 or placebo (which has no active ingredient). Treatment would be given on alternate weeks over a 50 week period. At the end of treatment there is a further visit to check the patient's safety.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1019
Date of REC Opinion
22 Jul 2014
REC opinion
Further Information Favourable Opinion