Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.

Official Title
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A Phase I, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess Safety,Tolerability, Pharmacokinetics and Efficacy of MEDI-578, an Anti-NGF Monoclonal Antibody, After Single Ascending Doses in Male and Non-fertile Female Patients With Painful Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Pain

Intervention / Treatment
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* Drug: MEDI-578
* Drug: Placebo for MEDI-578


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with painful osteoarthritis of the knee. The pain from the knee must exceed pain experienced from any other condition. Patients must be willing and able to discontinue all current analgesic treatment. Exclusion Criteria: Any other form of arthritis than osteoarthritis. Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis. Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MEDI-578<br>* intravenous infusion, once<br>|
| Placebo Comparator: 2<br> | Drug: Placebo for MEDI-578<br>* Intravenous infusion, once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, ECG, safety lab) |  | Assessments performed at (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 2. Thereafter weekly assessments until week 4 when a fortnightly schedule is followed until week 8. A final assessment at week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of MEDI-578 in plasma. |  | Blood sampling performed at (predose, then ranging from every hour to every 24 hour) on Day 1 and 2. Thereafter weekly blood sampling until week 4, when a fortnightly schedule is followed until week 8. A final assessment at week 12. | 
| To assess the immunogenicity of MEDI-578 |  | Blood samples taken fortnightly from Day 1 until week 12. | 
| To evaluate the analgesic efficacy of MEDI-578 during the night and day. |  | Patients will record their pain intensity every morning and evening during the 13 weeks study period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-NGF, OA, pain