Open-label Extension Study Of RN624

Study Overview
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Brief Summary
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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.

Official Title
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OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.

Conditions
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Osteoarthritis, OA Knee Pain, Arthritis

Intervention / Treatment
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* Drug: RN624 (PF-04383119)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RN624 (PF-04383119)<br>* 50 mcg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline up to 12 weeks after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| 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 | 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. | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| 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 | 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. | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| 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 | 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. | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 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. | A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| Number of Participants With Response to Participant Satisfaction Questionnaire | 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. | A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| 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 | 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 . | A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72 | 
| Percentage of Participants Who Discontinued the Study |  | A4091009: Baseline up to 12 weeks after last dose of study drug | 
| Median Time in Study A4091009 | Median time of participation in the study for all the participants was evaluated. | A4091009: Baseline up to 12 weeks after last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monoclonal antibody