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

This study has been terminated.
(Amended clinical development plan.)
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01072591
First received: February 19, 2010
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]
  • To assess the immunogenicity of MEDI-578 [ Time Frame: Blood samples taken fortnightly from Day 1 until week 12. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01072591     History of Changes
Other Study ID Numbers: D2460C00001
Study First Received: February 19, 2010
Last Updated: January 28, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
anti-NGF
OA
pain

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

ClinicalTrials.gov processed this record on October 22, 2014