Fulranumab as Adjunctive Therapy for OA of Hip or Knee (3007)
Research type
Research Study
Full title
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee
IRAS ID
171638
Contact name
Aliya Asher
Contact email
Sponsor organisation
Janssen Research & Development, LLC
Eudract number
2014-003224-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 22 days
Research summary
This study is a randomised, double-blind, multi-phase, placebo controlled, parallel-group, safety, tolerability and efficacy study examining fulranumab as adjunctive therapy, compared to placebo in partcipants with signs and symptoms of hip or knee osteoarthritis that are not adequately controlled by current pain therapy, and who are planning a joint replacement surgery.
Participants would be on the study for up to 67 weeks, in three phases:
Screening phase - A 3 week period, including a 7 day washout period for non-steriodal anti-inflammatory drugs (such as ibuprofen, aspirin, etc)
Double blind treatment phase - A 16 week period, where participants will be randomised into three groups in a ratio of 1:1:1, two of these groups will receive different doses of fulranumab, and the remaining group will receive a placebo. A participant will have a 2 in 3 chance of receiving fulranumab. Participants will be given a sub-cutaneous injection of either fulranumab or placebo once every four weeks during the treatment phase (a total of four injections).
Post treatment follow up - A period of up to 48 weeks where the participant will be monitored to assess the safety and efficacy of fulranumab.
Participants will be asked if they would like to take a blinded supplemental oral painkiller at the start of the treatment period, to be taken twice daily, until the end of the double-blind treatment phase. Additionally, after the start of the treatment period, participants can request the supplemental oral painkiller in addition to their standard of care, which they would need to take for the remaining period of the treatment phase. Participants who are receiving fulranumab will be given a placebo oral capsule.
The planned global number of participants for this study is 900 men or women aged 18 years or older.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0381
Date of REC Opinion
25 Jun 2015
REC opinion
Further Information Favourable Opinion