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

Phase 1TerminatedNCT01072591

AstraZeneca108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

108

Conditions

Osteoarthritis Pain

Interventions

MEDI-578DRUG

intravenous infusion, once

Placebo for MEDI-578DRUG

Intravenous infusion, once

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

London Bridge, Greater London, United Kingdom

Outcomes

Primary Outcomes

Safety variables (adverse events, vital signs, ECG, safety lab)

Time frame: 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 Outcomes

To characterize the pharmacokinetics of MEDI-578 in plasma.

Time frame: 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

Time frame: Blood samples taken fortnightly from Day 1 until week 12.

To evaluate the analgesic efficacy of MEDI-578 during the night and day.

Time frame: Patients will record their pain intensity every morning and evening during the 13 weeks study period.

Data from ClinicalTrials.gov

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