A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

Study Overview
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Brief Summary
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The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

Official Title
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A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: RN624 (PF-04383119)
* Drug: RN624 (PF-04383119)
* Drug: RN624 (PF-04383119)
* Drug: RN624 (PF-04383119)
* Drug: RN624 (PF-04383119)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain). Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery Exclusion Criteria: History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>monoclonal antibody | Drug: RN624 (PF-04383119)<br>* 10 mcg/kg<br>|
| Experimental: 2<br> | Drug: RN624 (PF-04383119)<br>* 25 mcg/kg<br>|
| Experimental: 3<br> | Drug: RN624 (PF-04383119)<br>* 50 mcg/kg<br>|
| Experimental: 4<br> | Drug: RN624 (PF-04383119)<br>* 100 mcg/kg<br>|
| Experimental: 5<br> | Drug: RN624 (PF-04383119)<br>* 200 mcg/kg<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking knee pain scores |  | Day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall knee pain scores |  | Day 112 | 
| Incidence of adverse events and serious adverse events |  | Day 112 | 
| WOMAC |  | Day 112 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis monoclonal antibody