A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: placebo; Drug: RN624 (PF-04383119)

• Registration Number: NCT00394563
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-10-30
• Study First Submitted QC: 2006-10-30
• Study First Posted: 2006-11-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Disposition First Submitted: 2009-04-04
• Status Verified: 2009-10
• Disposition First Submitted QC: 2009-10-07
• Last Update Submitted: 2009-10-07
• Disposition First Posted: 2009-10-12
• Last Update Posted: 2009-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

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Exclusion Criteria

History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
1	RN624 (PF-04383119)	monoclonal antibody
2	RN624 (PF-04383119)	-
3	RN624 (PF-04383119)	-
4	RN624 (PF-04383119)	-
5	RN624 (PF-04383119)	-

Primary Outcome Measures

Name	Time	Method
Walking knee pain scores	Day 112

Secondary Outcome Measures

Name	Time	Method
Overall knee pain scores	Day 112
Incidence of adverse events and serious adverse events	Day 112
WOMAC	Day 112

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Yakima, Washington, United States