Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394563
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : October 12, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: RN624 (PF-04383119) Drug: placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee
Study Start Date : March 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 1
monoclonal antibody
Drug: RN624 (PF-04383119)
10 mcg/kg

Experimental: 2 Drug: RN624 (PF-04383119)
25 mcg/kg

Experimental: 3 Drug: RN624 (PF-04383119)
50 mcg/kg

Experimental: 4 Drug: RN624 (PF-04383119)
100 mcg/kg

Experimental: 5 Drug: RN624 (PF-04383119)
200 mcg/kg

Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. Walking knee pain scores [ Time Frame: Day 112 ]

Secondary Outcome Measures :
  1. Overall knee pain scores [ Time Frame: Day 112 ]
  2. Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ]
  3. WOMAC [ Time Frame: Day 112 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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 identifier (NCT number): NCT00394563

  Show 48 Study Locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00394563     History of Changes
Other Study ID Numbers: A4091008
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009
Keywords provided by Pfizer:
osteoarthritis monoclonal antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents