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

This study has been terminated.
(Amended clinical development plan.)
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 19, 2010
Last updated: January 28, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Osteoarthritis Pain Drug: MEDI-578 Drug: Placebo for MEDI-578 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]

Enrollment: 108
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MEDI-578
intravenous infusion, once
Placebo Comparator: 2 Drug: Placebo for MEDI-578
Intravenous infusion, once


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01072591

United Kingdom
Research Site
London Bridge, Greater London, United Kingdom
Sponsors and Collaborators
MedImmune LLC
Study Director: Rolf Karlsten AstraZeneca RD Södertälje
  More Information

Responsible Party: AstraZeneca Identifier: NCT01072591     History of Changes
Other Study ID Numbers: D2460C00001
Study First Received: February 19, 2010
Last Updated: January 28, 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on July 19, 2017