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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009318-41 | EudraCT Number | ||
| P3 6 MO OA HIP/KNEE DICLOFENAC | Other Identifier | Alias Study Number |
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See termination reason in detailed description.
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The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tanezumab 10 mg + diclofenac | Experimental | IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) |
|
| Tanezumab 5 mg + diclofenac | Experimental | IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) |
|
| Tanezumab 2.5 mg + diclofenac | Experimental | IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) |
|
| IV placebo + diclofenac | Placebo Comparator | IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanezumab | Biological | IV tanezumab 10 mg every 8 weeks (through Week 16) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. | Baseline, Week 16 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | Baseline, Week 16 |
| Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intravenous Doses of Study Medication | Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received. | Day 1 up to Week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Medizinische Universitatsklinik Graz | Graz | A-8036 | Austria | |||
| Nuhr Zentrum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30936738 | Derived | Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. | |
| 26554876 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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After screening, participants received study supplied diclofenac slow release (SR) 75 mg tablet twice daily for a minimum of 14 days prior to randomization.
Participants with osteoarthritis of knee or hip who were receiving and tolerating stable dose of diclofenac 150 milligram (mg) per day but required additional pain relief were recruited in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Diclofenac | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32. |
| FG001 | Tanezumab 2.5 mg + Diclofenac |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| diclofenac | Drug | Oral diclofenac SR 75 mg BID for 32 weeks |
|
| tanezumab | Biological | IV tanezumab 5 mg every 8 weeks (through Week 16) |
|
| diclofenac | Drug | Oral diclofenac SR 75 mg BID for 32 weeks |
|
| tanezumab | Biological | IV tanezumab 2.5 mg every 8 weeks (through Week 16) |
|
| diclofenac | Drug | Oral diclofenac SR 75 mg BID for 32 weeks |
|
| diclofenac | Drug | Oral diclofenac SR 75 mg BID for 32 weeks |
|
| IV placebo | Other | IV placebo to match tanezumab every 8 weeks (through Week 16) |
|
| Baseline, Week 16 |
| Baseline, Weeks 2, 4, 8, 12, and 24 |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | Baseline, Weeks 2, 4, 8, 12, and 24 |
| Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. | Baseline, Weeks 2, 4, 8, 12, and 24 |
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | OMERACT-OARSI responder: participant has >=50 percent (%) change and >=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: >=20% change and >=1 absolute change from Baseline in WOMAC pain subscale; >=20% change and >=1 absolute change from Baseline in the WOMAC physical function subscale; >=20% change and >=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor. | Weeks 2, 4, 8, 12, 16, and 24 |
| Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported. | Baseline, Week 16 and 24 |
| Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
| Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement. | Weeks 2, 4, 8, 12, 16, and 24 |
| Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement. | Weeks 2, 4, 8, 12, 16, and 24 |
| Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement. | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement. | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | WOMAC Index: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement. | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Participants answered the question: "How much pain have you had when walking on a flat surface?" Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. | Baseline, Week 2, 4, 8, 12, 16, 24 |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Participants answered the question: "How much pain have you had when going up or down the stairs?" Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement. | Baseline, Week 12, and 24 |
| Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. | Baseline, Week 12 and 24 |
| Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening. | Baseline, Week 24 |
| Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants "no dysfunction, moderate or some dysfunction and extreme dysfunction" and change from baseline in EQ-5D individual health state profile was determined as number of participants "improved, no change or worsened". | Baseline, Week 24 |
| Number of Participants Who Discontinued Due to Lack of Efficacy | Number of participants who discontinued due to lack of efficacy were reported. | Baseline up to end of study (Week 32) |
| Time to Discontinuation (TTD) Due to Lack of Efficacy | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. | Baseline up to Week 16 and 24 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Baseline up to 112 days after last intravenous dose (up to Week 32) |
| Senftenberg |
| 3541 |
| Austria |
| ClinPharm International GmbH | Vienna | A-1090 | Austria |
| Medizinische Universitaet Wien/AKH | Vienna | A-1090 | Austria |
| Rheuma Zentrum Favoriten | Vienna | A-1100 | Austria |
| CHU de Nantes | Nantes | 44093 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Charité-Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Klinische Forschung Berlin-Buch GmbH | Berlin | 13125 | Germany |
| Apotheke | Berlin | 13353 | Germany |
| Herz Apotheke | Bochum | 44787 | Germany |
| Synexus ClinPharm GmbH | Bochum | 44787 | Germany |
| Viereck-Apotheke | Buch | 13125 | Germany |
| Synexus ClinParm GmbH | Dresden | 01067 | Germany |
| Apotheke im Arztehaus Mickten | Dresden | 01127 | Germany |
| Schiller Apotheke & Stadt Apotheke | Göppingen | 73033 | Germany |
| Schmerz- und Palliativzentrum Goeppingen | Göppingen | 73033 | Germany |
| Falken Apotheke Hoheluft | Hamburg | 20253 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| Klinische Forschung Hannover - Mitte GmbH | Hanover | 30159 | Germany |
| Loewen-Apotheke | Hanover | 30159 | Germany |
| Synexus ClinPharm GmbH | Leipzig | 04103 | Germany |
| Arkana Apotheke OHG | Leipzig | 04315 | Germany |
| Synexus ClinPharm GmbH | Magdeburg | 39104 | Germany |
| Apotheke im MSZ | Magdeburg | 39112 | Germany |
| Apotheke des Ernst von Bergmann Klinikums | Potsdam | 14467 | Germany |
| Synexus ClinParm GmbH | Potsdam | 14467 | Germany |
| Kirchsteig Apotheke | Potsdam | 14480 | Germany |
| "Centrum Medyczne MEDENS S.C. Niepubliczny Zaklad | Chełm Śląski | 41-403 | Poland |
| Malopolskie Centrum Medyczne s.c. | Krakow | 31-510 | Poland |
| Centrum Medyczne OSTEOMED Sp. z o. o. | Warsaw | 02-256 | Poland |
| Synexus SCM Sp. z o.o. | Wroclaw | 50-088 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "POLIMEDICA" | Zgierz | 95-100 | Poland |
| Municipal Hospital No. 1 "Schuller" | Ploieşti | Prahova | 100337 | Romania |
| Clinical Emergency Military Hospital "Dr. Carol Davila" | Bucharest | 010225 | Romania |
| Duo Medical srl | Bucharest | 010584 | Romania |
| Medical Center "SANA" | Bucharest | 011025 | Romania |
| Clinical Hospital "Sf. Maria" | Bucharest | 011172 | Romania |
| Center of Rheumatology "Dr Ion Stoia" | Bucharest | 020985 | Romania |
| Clinical Emergency County Hospital Constanta | Constanța | 900591 | Romania |
| County Emergency Clinic Hospital "Sf. Apostol Andrei" | Galati | 800578 | Romania |
| Center polyclinic of Federal State Institution | Arkhangelsk | 163000 | Russia |
| State Healthcare Institution of Moscow city "City Clinical Hospital #15 n.a. O. M. Filatov" | Moscow | 111539 | Russia |
| Chair of Hospital Therapy of Ryazan State Medical University | Ryazan | 390026 | Russia |
| St. Petersburg State Healthcare Institution "City Hospital #25 City Rheumatology Center" | Saint Petersburg | 190068 | Russia |
| State Educational Institution of Additional Professional Education | Saint Petersburg | 191015 | Russia |
| Institution of Russian Academy of Sciences "St. Petersburg Clinical Hospital of RAS" | Saint Petersburg | 194017 | Russia |
| St. Petersburg State Healthcare Institution "City Outpatient Clinical #51" | Saint Petersburg | 196211 | Russia |
| St. Petersburg State Healthcare Institution "City Pokrovskaya Hospital" | Saint Petersburg | 199106 | Russia |
| Hospital Nuestra Señora de la Esperanza | Santiago de Compostela | A Coruna | 15705 | Spain |
| Centro Salud Petrer 1 | Petrel | Alicante | 03610 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Hospital Comarcal de Elda | Elda Alicante | 03600 | Spain |
| Hospital Universitario Getafe | Getafe-Madrid | 28905 | Spain |
| Hospital G. U. Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Clinico Universitario Santiago | Santiago de Compostela | 15706 | Spain |
| Me3plus AB | Gothenburg | 400 14 | Sweden |
| Me3plus AB | Gothenburg | 412 63 | Sweden |
| Center for Lakemedelsstudier | Malmö | 211 52 | Sweden |
| Medicinskt Centrum | Norrköping | 602 32 | Sweden |
| Chernivtsi Regional Clinical Hospital,Department of Rheumatology | Chernivtsi | 58000 | Ukraine |
| Road Clinical Hospital at Dnipropetrovsk station, Department of Rheumatology | Dnipropetrovsk | 49008 | Ukraine |
| Institute of Urgent and Recovery Surgery named after V.K. Gusaka AMS Ukraine | Donetsk | 83045 | Ukraine |
| Central City Clinical Hospital#1, Department of Therapy, | Donetsk | 83114 | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | 76018 | Ukraine |
| City Clinical Hospital #8, Department of reumatology, | Kharkiv | 61176 | Ukraine |
| State Institution "Institute of Gerontology AMS of Ukraine" | Kiev | 04114 | Ukraine |
| Oleksandrivska Clinical Hospital in Kyiv-Department of Rheumatology # 1 | Kyiv | 01023 | Ukraine |
| Kyiv Central Basin Clinical Hospital, Department of cardiology, | Kyiv | 04053 | Ukraine |
| 4th City Communal Clinical Hospital, Department of Rheumatology, | Lviv | 79011 | Ukraine |
| City communal clinical hospital #5, Dept. of Therapy, Danylo Galytskiy Lviv National Med. University | Lviv | 79013 | Ukraine |
| Communal Institution Ternopil regional council, "Ternopil Regional Clinical Hospital" | Ternopil | 46001 | Ukraine |
| Vinnytsya regional clinical hospital named after M.I. Pyrogova | Vinnytsia | 21018 | Ukraine |
| Communal institution "City Hospital #7", Department of Therapy, | Zaporizhzhia | 69118 | Ukraine |
| Barnsley Hospital NHS Trust | Barnsley | South Yorkshire | S75 2EP | United Kingdom |
| Department of Rheumatology | Dudley, West Midlands | DY1 2HQ | United Kingdom |
| Wrightington Hospital | Wigan | WN6 9EP | United Kingdom |
| Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492. |
| 23852695 | Derived | Balanescu AR, Feist E, Wolfram G, Davignon I, Smith MD, Brown MT, West CR. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Ann Rheum Dis. 2014 Sep;73(9):1665-72. doi: 10.1136/annrheumdis-2012-203164. Epub 2013 Jul 12. |
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| FG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| FG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Diclofenac | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32. |
| BG001 | Tanezumab 2.5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| BG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| BG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. | Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. Last observation carried forward (LOCF) method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Primary | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, and 24 |
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| Secondary | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, and 24 |
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| Secondary | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, and 24 |
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| Secondary | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF | OMERACT-OARSI responder: participant has >=50 percent (%) change and >=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: >=20% change and >=1 absolute change from Baseline in WOMAC pain subscale; >=20% change and >=1 absolute change from Baseline in the WOMAC physical function subscale; >=20% change and >=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Number | percentage of participants | Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here ' overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Number | percentage of participants | Baseline, Week 16 and 24 |
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| Secondary | Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Number | percentage of participants | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Number | percentage of participants | Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) | Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. BOCF method was used to impute missing values. | Posted | Number | percentage of participants | Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 | Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24 | WOMAC Index: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24 | Participants answered the question: "How much pain have you had when walking on a flat surface?" Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, 4, 8, 12, 16, 24 |
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| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24 | Participants answered the question: "How much pain have you had when going up or down the stairs?" Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24 | SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, and 24 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24 | SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | z-score | Baseline, Week 12 and 24 |
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| Secondary | Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening. | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure and 'number analyzed' signifies number of participants evaluable for each specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| Secondary | Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24 | EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants "no dysfunction, moderate or some dysfunction and extreme dysfunction" and change from baseline in EQ-5D individual health state profile was determined as number of participants "improved, no change or worsened". | ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). Here 'overall number of participants analyzed' signifies participants evaluable for this measure. LOCF method was used to impute missing values. | Posted | Count of Participants | Participants | Baseline, Week 24 |
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| Secondary | Number of Participants Who Discontinued Due to Lack of Efficacy | Number of participants who discontinued due to lack of efficacy were reported. | The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). | Posted | Count of Participants | Participants | Baseline up to end of study (Week 32) |
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| Secondary | Time to Discontinuation (TTD) Due to Lack of Efficacy | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. | The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). | Posted | Median | 95% Confidence Interval | days | Baseline up to Week 16 and 24 |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). | Posted | Count of Participants | Participants | Baseline up to 112 days after last intravenous dose (up to Week 32) |
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| Other Pre-specified | Number of Participants With Intravenous Doses of Study Medication | Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received. | The ITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). | Posted | Count of Participants | Participants | Day 1 up to Week 16 |
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Not provided
Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Placebo + Diclofenac | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 milligram (mg) slow release tablet orally twice daily up to Week 32. | 8 | 152 | 38 | 152 | ||
| EG001 | Tanezumab 2.5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 12 | 157 | 36 | 157 | ||
| EG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 8 | 150 | 48 | 150 | ||
| EG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. | 10 | 145 | 46 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Benign familial pemphigus | Congenital, familial and genetic disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal rigidity | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Due to United States Food and Drug Administration (FDA) imposed clinical hold, further study drug dosing was stopped prematurely and study was terminated.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549319 | tanezumab |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 45 to 64 years |
|
| Greater than or equal to (>=) 65 years |
|
| Male |
|
| Change at Week 16 |
|
LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect. |
| ANCOVA |
| 0.011 |
| LS Mean Difference |
| -0.52 |
| Standard Error of the Mean |
| 0.20 |
| 2-Sided |
| 95 |
| -0.91 |
| -0.12 |
| Superiority or Other (legacy) |
| LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect. | ANCOVA | 0.005 | LS Mean Difference | -0.57 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.97 | -0.17 | Superiority or Other (legacy) |
| Tanezumab 2.5 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|
| Tanezumab 2.5 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG001 | Tanezumab 2.5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG001 | Tanezumab 2.5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| Tanezumab 2.5 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| Tanezumab 5 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG001 | Tanezumab 2.5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32.
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| Tanezumab 10 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| Tanezumab 10 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG002 | Tanezumab 5 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
| OG003 | Tanezumab 10 mg + Diclofenac | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
| OG003 |
| Tanezumab 10 mg + Diclofenac |
Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion at Baseline, Week 8 and Week 16 along with diclofenac 75 mg slow release tablet orally twice daily up to Week 32. |
|
|
|