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

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ClinicalTrials.gov Identifier: NCT01072591
Recruitment Status : Terminated (Amended clinical development plan.)
First Posted : February 22, 2010
Last Update Posted : January 29, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Drug: MEDI-578 Drug: Placebo for MEDI-578 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : February 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: MEDI-578
intravenous infusion, once
Placebo Comparator: 2 Drug: Placebo for MEDI-578
Intravenous infusion, once


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. To assess the immunogenicity of MEDI-578 [ Time Frame: Blood samples taken fortnightly from Day 1 until week 12. ]
  3. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072591


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01072591     History of Changes
Other Study ID Numbers: D2460C00001
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
anti-NGF
OA
pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases