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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00394563
First received: October 30, 2006
Last updated: October 7, 2009
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
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

  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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00394563     History of Changes
Other Study ID Numbers: A4091008, RN624-CL006
Study First Received: October 30, 2006
Last Updated: October 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
osteoarthritis monoclonal antibody

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014