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

NCT01072591 | Terminated Phase 1 DMC

• 1 other identifier: D2460C00001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Pain

Keywords

anti-NGF; OA; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: MEDI-578

2

PLACEBO COMPARATOR

Drug: Placebo for MEDI-578

Interventions

MEDI-578 DRUG

intravenous infusion, once

1

Placebo for MEDI-578 DRUG

Intravenous infusion, once

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• MedImmune LLC: collaborator

Study Sites (1)

Research Site

London Bridge, Greater London, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Karlsten

  AstraZeneca RD Södertälje

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

GB (1)