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Open-label Extension Study Of RN624

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ClinicalTrials.gov Identifier: NCT00399490
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis OA Knee Pain Arthritis Drug: RN624 (PF-04383119) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Incidence of adverse events

Secondary Outcome Measures :
  1. Drop-out rate, time to drop-out, and reasons for drop out
  2. WOMAC subscales and average
  3. Subject global assessment
  4. SF-36

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT00399490

  Show 29 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2009

Keywords provided by Pfizer:
Monoclonal antibody

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases