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

Primary Purpose

Osteoarthritis, Pain

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

MEDI-578

Placebo for MEDI-578

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring anti-NGF, OA, pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety variables (adverse events, vital signs, ECG, safety lab)

Secondary Outcome Measures

To characterize the pharmacokinetics of MEDI-578 in plasma.

To assess the immunogenicity of MEDI-578

To evaluate the analgesic efficacy of MEDI-578 during the night and day.

Full Information

NCT ID

NCT01072591

First Posted

February 19, 2010

Last Updated

January 28, 2013

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT01072591

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Terminated

Why Stopped

Amended clinical development plan.

Study Start Date

February 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

MedImmune LLC

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Pain

Keywords

anti-NGF, OA, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MEDI-578

Intervention Description

intravenous infusion, once

Intervention Type

Drug

Intervention Name(s)

Placebo for MEDI-578

Intervention Description

Intravenous infusion, once

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

Title

To assess the immunogenicity of MEDI-578

Time Frame

Blood samples taken fortnightly from Day 1 until week 12.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolf Karlsten

Organizational Affiliation

AstraZeneca RD Södertälje

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

London Bridge

State/Province

Greater London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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