Open-label Extension Study Of RN624

Phase 2

Completed

• Conditions: Osteoarthritis; OA Knee Pain; Arthritis
• Interventions: Drug: RN624 (PF-04383119)

• Registration Number: NCT00399490
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09-15
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Primary Completion: 2008-02-11
• Study Completion: 2008-02-11
• Disposition First Submitted: 2009-04-06
• Disposition First Submitted QC: 2009-10-07
• Disposition First Posted: 2009-10-12
• Status Verified: 2020-11
• Results First Submitted: 2021-01-11
• Results First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Results First Posted: 2021-02-02
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Enrolled in Study RN624-CL006

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RN624 (PF-04383119)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 12 weeks after last dose of study drug	AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.
Number of Participants With Response to Participant Satisfaction Questionnaire	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .
Percentage of Participants Who Discontinued the Study	A4091009: Baseline up to 12 weeks after last dose of study drug
Median Time in Study A4091009	A4091009: Baseline up to 12 weeks after last dose of study drug	Median time of participation in the study for all the participants was evaluated.

Trial Locations

Locations (36)

Sports Medicine and Orthopaedics Center; 🇺🇸 Greensboro, North Carolina, United States

Office of Walter F. Chase, MD, PA; 🇺🇸 Austin, Texas, United States

Northwest Indiana Center for Clinical Research; 🇺🇸 Merrillville, Indiana, United States

Covance Clinical Research Unit, Inc; 🇺🇸 Daytona Beach, Florida, United States

Ocala Rheumatology Research Center; 🇺🇸 Ocala, Florida, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Pharmacotherapy Research Associates Incorporated; 🇺🇸 Zanesville, Ohio, United States

Clinical Pharmacology Study Group; 🇺🇸 Worcester, Massachusetts, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Covance Boise; 🇺🇸 Boise, Idaho, United States

Volunteer Research Group; 🇺🇸 Knoxville, Tennessee, United States

Pharmquest; 🇺🇸 Greensboro, North Carolina, United States

Pivotal Research; 🇺🇸 Midvale, Utah, United States

Arizona Research Center, LLC; 🇺🇸 Phoenix, Arizona, United States

Imaging Centers of Anaheim; 🇺🇸 Anaheim, California, United States

Orange County Clinical Research; 🇺🇸 Anaheim, California, United States

David M. Radin, MD; 🇺🇸 Stamford, Connecticut, United States

Covance Clinical Research Unit, Inc. Honolulu; 🇺🇸 Honolulu, Hawaii, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States

Albuquerque Clinical Trials; 🇺🇸 Albuquerque, New Mexico, United States

New Orleans Center for Clinical Research; 🇺🇸 Knoxville, Tennessee, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

AAIR Research Center; 🇺🇸 Rochester, New York, United States

Clinical Trials Northwest; 🇺🇸 Yakima, Washington, United States

BrookWood Internal Medicine; 🇺🇸 Birmingham, Alabama, United States

Tampa Medical Group, PA; 🇺🇸 Tampa, Florida, United States

Rheumatology Associates of South Texas; 🇺🇸 San Antonio, Texas, United States

South Texas Radiology Imaging Center; 🇺🇸 San Antonio, Texas, United States

Habana Hospital Pharmacy; 🇺🇸 Tampa, Florida, United States

Office of David Neustadt, PSL; 🇺🇸 Louisville, Kentucky, United States

Radiant Research San Antonio Northeast; 🇺🇸 San Antonio, Texas, United States

Radiant Research - San Antonio; 🇺🇸 San Antonio, Texas, United States

Center for Pharmaceutical Research, P.C.; 🇺🇸 Kansas City, Missouri, United States

Quality Clincal Research; 🇺🇸 Omaha, Nebraska, United States

Radiant Research; 🇺🇸 Birmingham, Alabama, United States