A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00394563

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: RN624 (PF-04383119) Drug: placebo	Phase II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Walking knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ] [ Designated as safety issue: Yes ]
WOMAC [ Time Frame: Day 112 ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	March 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental monoclonal antibody	Drug: RN624 (PF-04383119) 10 mcg/kg
2: Experimental	Drug: RN624 (PF-04383119) 25 mcg/kg
3: Experimental	Drug: RN624 (PF-04383119) 50 mcg/kg
4: Experimental	Drug: RN624 (PF-04383119) 100 mcg/kg
5: Experimental	Drug: RN624 (PF-04383119) 200 mcg/kg
placebo: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394563

Show 48 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091008, RN624-CL006
Study First Received:	October 30, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00394563
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

osteoarthritis monoclonal antibody

Study placed in the following topic categories:

Antibodies, Monoclonal
Osteoarthritis, Knee
Antibodies
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on January 16, 2009