Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT01127893
Status:
TERMINATED
Last Update Posted:
2021-03-10
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549319', 'term': 'tanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the US FDA imposed clinical hold, enrollment and further dosing with study medication was stopped prematurely, only 1 participant was enrolled and the study was terminated early. Designation of outcomes as primary, secondary based on study team input as study did not specify them as primary or secondary.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is 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, up to early termination (Day 107) that were absent before treatment in this study or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Laboratory examination included blood chemistry, hematology and urinalysis. Reported results were to include abnormal laboratory findings without regard to baseline abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': "Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), QT interval corrected using Fredericia's formula (QTcF), RR interval and heart rate (HR).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Neurologic Examination Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Neurologic examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Injection site reactions included: erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection has been administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': "The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicated worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'PGA: Participants answered the following question: "Considering all the ways your osteoarthritis (OA) in your knee affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'OMERACT-OARSI response: \\>=50 percent (%) improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement of At Least (>=) 2 Point in Patient Global Assessment (PGA) of Osteoarthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'PGA: Participants answered the following question: "Considering all the ways your OA in your joint affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned efficacy analysis was not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; where higher scores indicated more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicated more stiffness. Stiffness is defined as a sensation of decreased ease in movement of the index joint.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'WOMAC: 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. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicated worse response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, only 1 participant was enrolled and the study was terminated prematurely. Consequently, planned analyses for Week 8, 16, 24, 32, 40, 48, 56, and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline up to Week 64', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed since no participant discontinued the study due to lack of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Concomitant Analgesic Medication for Osteoarthritis Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 107 (Early Termination)', 'description': "Permissible concomitant analgesic medications included Food and Drug Administration (FDA) approved opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (for example, hyaluronan) and were to be prescribed as per investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely. Consequently, all planned analyses were not performed; data reported here is for baseline up to early termination (Day 107).'}, {'type': 'SECONDARY', 'title': 'Days Per Week of Concomitant Analgesic Medication Usage for Osteoarthritis Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'timeFrame': 'Baseline up to Week 64', 'description': "Permissible concomitant analgesic medications included Food and Drug Administration (FDA) approved opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (for example, hyaluronan) and were to be prescribed as per investigator's discretion.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed since no participant received concomitant analgesic medication.'}, {'type': 'SECONDARY', 'title': 'Tanezumab Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination (Day 107)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not reported since the observed concentration was below lower limit of quantification (12 ng/mL).', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Week 8, 24, 40; Week 56, 64', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely (Day 107). Consequently, planned analyses for Week 24, 40, 56 and 64 were not performed.'}, {'type': 'SECONDARY', 'title': 'Nerve Growth Factor (NGF) Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '1138', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination (Day 107)', 'categories': [{'measurements': [{'value': '208.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Week 8, 24, 40; Week 56, 64', 'description': 'Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all randomized participants who received at least 1 dose of study medication. Due to the US FDA imposed clinical hold, the study was terminated prematurely (Day 107). Consequently, planned analyses for Week 24, 40, 56 and 64 were not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Termination by the Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who had received tanezumab 2.5 milligram(mg) subcutaneously(SC) every 8 weeks, 5 mg SC every 8 weeks or 10 mg SC or intravenously every 8 weeks in parent Study A4091027 (NCT01089725) were to be assigned to same dose group and who received placebo in same parent study, were to be randomized to either tanezumab 2.5, 5 or 10 mg SC every 8 weeks in this study.', 'preAssignmentDetails': 'Due to the United States Food and Drug Administration (US FDA) imposed clinical hold, the study was terminated prematurely. Only 1 participant was enrolled and treated with tanezumab 2.5 mg treatment group and other planned treatments, tanezumab 5 or 10 mg, were not administered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tanezumab 2.5 mg', 'description': 'Participants who had previously received tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection every 8 weeks in parent Study A4091027 (NCT01089725), received single dose of tanezumab 2.5 mg subcutaneous injection on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) analysis population included all randomized participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2012-10-01', 'completionDateStruct': {'date': '2010-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2010-05-20', 'dispFirstSubmitQcDate': '2012-10-08', 'resultsFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2010-05-20', 'dispFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-03', 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is 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, up to early termination (Day 107) that were absent before treatment in this study or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Laboratory examination included blood chemistry, hematology and urinalysis. Reported results were to include abnormal laboratory findings without regard to baseline abnormality.'}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': "Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), QT interval corrected using Fredericia's formula (QTcF), RR interval and heart rate (HR)."}, {'measure': 'Number of Participants With Neurologic Examination Abnormalities', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Neurologic examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.'}, {'measure': 'Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Number of Participants With Injection Site Reactions', 'timeFrame': 'Baseline up to Early Termination (Day 107)', 'description': 'Injection site reactions included: erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection has been administered.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': "The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on a NRS of 0 to 10, where higher scores indicated worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living."}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'PGA: Participants answered the following question: "Considering all the ways your osteoarthritis (OA) in your knee affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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).'}, {'measure': 'Percentage of Participants With Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Response', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'OMERACT-OARSI response: \\>=50 percent (%) improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).'}, {'measure': 'Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.'}, {'measure': 'Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 to 10, where higher scores indicated higher pain.'}, {'measure': 'Percentage of Participants With Improvement of At Least (>=) 2 Point in Patient Global Assessment (PGA) of Osteoarthritis', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'PGA: Participants answered the following question: "Considering all the ways your OA in your joint affects you, how are you doing today?" Participants rated their condition by using a 5-point Likert scale: 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).'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced in the index joint in the past 48 hours. It was calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; where higher scores indicated more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicated more stiffness. Stiffness is defined as a sensation of decreased ease in movement of the index joint.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'WOMAC: 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. WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicated worse response.'}, {'measure': 'Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.'}, {'measure': 'Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64', 'timeFrame': 'Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64', 'description': 'Participants answered: "How much pain have you had when going up or down stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.'}, {'measure': 'Time to Discontinuation Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Week 64'}, {'measure': 'Number of Participants Who Received Concomitant Analgesic Medication for Osteoarthritis Treatment', 'timeFrame': 'Baseline up to Day 107 (Early Termination)', 'description': "Permissible concomitant analgesic medications included Food and Drug Administration (FDA) approved opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (for example, hyaluronan) and were to be prescribed as per investigator's discretion."}, {'measure': 'Days Per Week of Concomitant Analgesic Medication Usage for Osteoarthritis Treatment', 'timeFrame': 'Baseline up to Week 64', 'description': "Permissible concomitant analgesic medications included Food and Drug Administration (FDA) approved opioids, topical analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (for example, hyaluronan) and were to be prescribed as per investigator's discretion."}, {'measure': 'Tanezumab Plasma Concentration', 'timeFrame': 'Pre-dose on Week 8, 24, 40; Week 56, 64'}, {'measure': 'Nerve Growth Factor (NGF) Serum Concentration', 'timeFrame': 'Pre-dose on Week 8, 24, 40; Week 56, 64', 'description': 'Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Musculoskeletal Diseases', 'Joint Diseases', 'Arthritis', 'Rheumatic Diseases'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091032&StudyName=Safety%20Extension%20Study%20Of%20Tanezumab%20When%20Administered%20By%20Subcutaneous%20Injection%20To%20Patients%20With%20Osteoarthritis%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks', 'detailedDescription': 'This study was terminated on 29 September 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have participated in specific Phase 3 parent study\n\nExclusion Criteria:\n\n* Failed screening for parent study, pregnant women, lactating mothers'}, 'identificationModule': {'nctId': 'NCT01127893', 'briefTitle': 'Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE', 'orgStudyIdInfo': {'id': 'A4091032'}, 'secondaryIdInfos': [{'id': 'SAFETY EXTENSION OF 1027', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tanezumab 10 mg', 'interventionNames': ['Biological: Tanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tanezumab 5 mg', 'interventionNames': ['Biological: Tanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tanezumab 2.5 mg', 'interventionNames': ['Biological: Tanezumab']}], 'interventions': [{'name': 'Tanezumab', 'type': 'BIOLOGICAL', 'description': 'Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections', 'armGroupLabels': ['Tanezumab 10 mg']}, {'name': 'Tanezumab', 'type': 'BIOLOGICAL', 'description': 'Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections', 'armGroupLabels': ['Tanezumab 5 mg']}, {'name': 'Tanezumab', 'type': 'BIOLOGICAL', 'description': 'Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections', 'armGroupLabels': ['Tanezumab 2.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Triwest Research Associates', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}