Open-label Extension Study Of RN624

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00399490
First received: November 14, 2006
Last updated: October 8, 2013
Last verified: October 2009
  Purpose

Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.


Condition Intervention Phase
Osteoarthritis
OA Knee Pain
Arthritis
Drug: RN624 (PF-04383119)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Multiple-Dose Study Of The Safety And Efficacy Of RN624 In Adults With Pain Due To Osteoarthritis Of The Knee

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: unspecified ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Drop-out rate, time to drop-out, and reasons for drop out [ Time Frame: unspecified ] [ Designated as safety issue: Yes ]
  • WOMAC subscales and average [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • Subject global assessment [ Time Frame: unspecified ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: unspecified ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RN624 (PF-04383119)
50 mcg/kg

  Eligibility

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

Inclusion Criteria:

  • Enrolled in Study RN624-CL006

Exclusion Criteria:

  • The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
  • Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study
  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: NCT00399490

  Show 29 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: Pfizer
ClinicalTrials.gov Identifier: NCT00399490     History of Changes
Other Study ID Numbers: A4091009, RN624-CL007
Study First Received: November 14, 2006
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Monoclonal antibody

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014