A Fulranumab study of Osteoarthritis of the hip or knee (3003)

• 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 Monotherapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee

• IRAS ID

  170973

• Contact name

  Matthew Dodd

• Contact email

  Matthew.Dodd@wales.nhs.uk

• Sponsor organisation

  Janssen Research & Development, LLC

• Eudract number

  2014-002598-13

• Clinicaltrials.gov Identifier

  NCT02289716

• Duration of Study in the UK

  1 years, 7 months, 31 days

• Research summary

  This study is a randomised, double blind, placebo controlled study to evaluate the efficacy, safety and tolerability of fulranumab as monotherapy in patients with chronic moderate to severe pain and functional impairment from osteoarthritis of the hip or knee, that is not adequately controlled by current pain therapy and who are due to have joint replacement surgery. Planned joint replacement surgery should be scheduled for 20 weeks or more after the date of randomisation.

  Patients 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 current pain medication

  Double blind treatment phase - A 16 week period, where patients 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 patient will have a 2 in 3 chance of receiving fulranumab. Patients 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 patient will be monitored to assess the safety and efficacy of fulranumab.

  The planned global number of patients for this study is 450 men or women aged 18 years or older.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  15/NE/0212

• Date of REC Opinion

  24 Jul 2015

• REC opinion

  Further Information Favourable Opinion