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

Phase 1

Terminated

• Conditions: Osteoarthritis; Pain
• Interventions: Drug: MEDI-578; Drug: Placebo for MEDI-578

• Registration Number: NCT01072591
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MEDI-578	-
2	Placebo for MEDI-578	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London Bridge, Greater London, United Kingdom