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
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 April 17, 2014