Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
      fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate
      to severe pain and functional impairment from knee or hip osteoarthritis that is not
      adequately controlled by current pain therapy.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double-blind (neither physician
      nor participant knows the name of the assigned drug), placebo-controlled (an inactive
      substance is given to one group of participants while active drug is given to another group
      of participants to see if there is a difference in response), parallel-group (study drugs
      given to participants in all treatment groups during the same time period) to evaluate the
      efficacy (capacity of the investigational drug to produce an effect), safety, and
      tolerability of fulranumab administered as adjunctive therapy (in combination with other drug
      therapy) to participants with chronic moderate to severe pain and functional impairment from
      knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy.
      The duration of participation in the study for an individual participant will be up to 67
      weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks,
      and a post-treatment follow-up period of up to 48 weeks). All participants will be randomly
      assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and
      given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16
      weeks. All participants will be allowed standard of care for OA pain during the double-blind
      treatment phase and must be taking an opioid at study entry and during the double-blind
      treatment phase. Blood samples will be collected from each participant at time points during
      the study. Safety evaluations will include assessment of adverse events, physical
      examinations, laboratory tests and vital signs which will be monitored throughout the study.
    

Intervention name(s): Placebo; Fulranumab 1 mg; Fulranumab 3 mg; Opioid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.; Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain; Fulranumab; JNJ-42160443; Adjunctive therapy; Opioid; Hip; Knee; Joint replacement surgery