arthritis osteoarthritis
Conditions
Interventions
Subjects will receive 4 subcutaneous (SC) injections of study drug during the
double-blind treatment
phase. Fulranumab will be administered as a 1 mg or 3 mg dose every 4 weeks by
SC injection of 0.
42160443PAI3003
Fulranumab
osteoarthrits hip or knee
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: The major inclusion criteria are: 1) Man or woman at least 18 years of age; 2) Clinical diagnosis of OA of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class *2) of the study joint; 3) Scheduled joint replacement surgery for the study joint *20 weeks after randomization or planning to undergo a joint replacement surgery for the study joint; 4) Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes at least one from each of the following 3 classes of oral analgesic medications (acetaminophen/paracetamol, NSAID, and opioid; 5) Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA with specific criteria applied to each scale and subscale. Eligibility criteria will be blinded to subjects, investigators, and site staff to reduce error variance, to improve accuracy of treatment estimates, and to avoid inclusion of subjects who cannot provide interpretable data. 6) During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child; Please refer to the protocol section 4.1 ( page 42-44) for a complete list of inclusion criteria)
Exclusion criteria
Exclusion criteria: The major exclusion criteria are medical history that suggests: 1) Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA); 2) Sympathetic dysfunction as defined in the protocol 3)Central nervous system abnormalities as defined in the protocol 4) Peripheral neurological deficits as defined in the protocol 5)Viral infections as defined in the protocol 6)Cardiovascular related conditions as defined in the protocol 7) History of inherited disorders associated with or causing hypercoagulopathy 8) History of malignanies within the past 2 years 9)Uncontrolled diabetes 10) any other chronic pain condition that would interfere with the subject's ability to assess their OA pain ( e.g fibromyalgia) 11) Creatinine clearance - 2.5 times ULN 13) BMI > 39 kg/m2 14) Other as described in the protocol;Please see a complete list of all exclusion criteria in the protocol section 4.2 (page 44-47)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary Efficacy Endpoints: Changes from baseline to the end of the 16-week double-blind phase in the WOMAC pain and physical function subscale scores and PGA score (for US FDA and Health Canada only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints: Change from baseline to the end of the 16-week double-blind phase in scores in: PGA score (not for US FDA and Health Canada), NRS for the study joint, WOMAC Stiffness subscale, Medical Outcomes Study (MOS) sleep scale, Short-Form-36 Health Survey (SF-36) subscales, EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scales, rescue medication use, as well as responder rates based on WOMAC pain and physical function subscales and PGA, separately, and responder rates for Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society (OMERACT-OARSI), Patient Acceptable Symptom State (PASS), Minimal Clinically Important Improvement (MCII). Exploratory Efficacy Endpoints: Changes from baseline to the end of the 16-week double-blind phase in: Australian/Canadian Osteoarthritis Hand Index (AUSCAN) scales for subjects with a pre-study diagnosis of OA of the hand. | — |
Countries
Austria, Belgium, Canada, Czechia, France, Netherlands, Poland, Romania, Spain, United Kingdom, United States of America
Outcome results
None listed