Fulranumab as adjunctive therapy for OA of hip or knee (3001)
Research type
Research Study
Full title
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Adjunctive Therapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee
IRAS ID
177662
Contact name
Aliya Asher
Contact email
Sponsor organisation
Janssen Research & Development, LLC
Eudract number
2013-001830-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 4 days
Research summary
This study is a randomised, 16-week, multi-phase, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy in participants with signs and symptoms of osteoarthritis of the hip or knee that were not adequately controlled by pain therapy and who are planning a joint replacement surgery.
The planned global number of participants for this study is 450 men or women aged 18 years or over.
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-steroidal anti-inflammatory drugs (NSAIDs - 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 subcutaneous 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.
All participants will be allowed standard of care for osteoarthritis pain therapy during the double-blind treatment phase. Participants must not change their standard of care except after consultation with the investigator.
Standard of care is any therapy, pharmacologic or non-pharmacologic with the exception of chronic oral NSAID use or use of aspirin (acetylsalicylic acid). Standard of care must include opioid therapy.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0408
Date of REC Opinion
17 Jul 2015
REC opinion
Further Information Favourable Opinion