Trial · NCT00809783

Extension Study Of Tanezumab In Osteoarthritis

NCT00809783, Phase 3, Terminated, Pfizer; results first posted 2021-05-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Extension Study Of Tanezumab In Osteoarthritis. Trials, record NCT00809783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00809783

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extension Study Of Tanezumab In Osteoarthritis
NCT number: NCT00809783
Status: Terminated
Phases: Phase 3
Enrollment: 2,147 participants, actual
Lead sponsor: Pfizer
Conditions: Osteoarthritis
Interventions: tanezumab, tanezumab, tanezumab
First posted: 2008-12-17
Last updated: 2021-05-10
Results first posted: 2021-05-10
Limitations and caveats: Due to FDA imposed clinical hold, enrollment was stopped prematurely and, therefore, not all study procedures and visits occurred as planned.

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)	AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Primary	Number of Participants With Abnormal Laboratory Findings	A4091016: Day 1 up to Week 80	Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(\<)0.8\lower limit of normal(LLN),MCV,MCH,MCHC\<0.9\LLN or \>1.1\ULN,platelet:\<0.5\LLN or \>1.75\upper limit of normal(ULN),white blood cell(WBC):\<0.6\LLN or \>1.5\ULN,lymphocyte,neutrophil,total neutrophil:\<0.8\LLN or\>1.2\ULN,basophil,eosinophil,monocyte:\>1.2\ULN;total,direct bilirubin\>1.5\ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:\> 3.0\ULN,total protein,albumin:\<0.8\LLN or \>1.2\ULN;blood urea nitrogen,creatinine:\>1.3\ULN,uric acid\>1.2\ULN;cholesterol,triglycerides\>1.3\ULN;sodium \<0.95\LLN or \>1.05\ULN,potassium,chloride,calcium,magnesium,bicarbonate:\<0.9\LLN or \>1.1\ULN,phosphate\<0.8\LLN or\>1.2\ULN;glucose \<0.6\LLN or \>1.5\ULN,glycosylated Hgb \>1.3\ULN,creatine kinase\>2.0\ULN;urine(specific gravity \<1.003or\>1.030,pH \<4.5or\>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals\>=1,RBC,WBC \>1.5\ULN,epithelial cell\>=6,casts,hyaline cast\>1,bacteria\>20).
Primary	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings	A4091016: Baseline (Day 1) up to Week 80	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.
Secondary	Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.
Secondary	Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab	A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)	Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Secondary	Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings	Baseline (Day 1) up to Week 80	Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.
Secondary	Number of Participants With Clinically Significant Abnormality in Vital Signs	A4091016: Baseline (Day 1) up to Week 80	Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Secondary	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Secondary	Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)	Intent to treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Abnormal Laboratory Findings	A4091016: Day 1 up to Week 80	ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783). Overall number of participants analyzed signifies those participants who were evaluable for this measure.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings	A4091016: Baseline (Day 1) up to Week 80	ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72	ITT population. Last observation carried forward (LOCF) method was used to impute missing values. Overall number of participants analyzed signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	units on a scale	MEAN
SECONDARY	Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab	A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)	ITT population. Overall number of participants analyzed signifies those participants who were evaluable for this measure at any time point. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings	Baseline (Day 1) up to Week 80	ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Abnormality in Vital Signs	A4091016: Baseline (Day 1) up to Week 80	ITT analysis set included all participants who received at least 1 dose of intravenous study medication during this study, A4091016 (NCT00809783).	participants	NUMBER
SECONDARY	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	ITT population. LOCF method was used to impute missing values. Overall number of participants analyzed signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.	units on a scale	MEAN
SECONDARY	Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	ITT population. LOCF method was used to impute missing values. Overall number of participants analyzed signifies those participants who were evaluable for this measure. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96 and 104 were not reported.	units on a scale	MEAN
SECONDARY	Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104	Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104	ITT population. LOCF method was used to impute missing values. 'Overall number of participants analyzed = participants who were evaluable for this measure. Number Analyzed = participants who were evaluable for this measure at given time points for each group, respectively. Efficacy results were not collected beyond Week 72 due to clinical hold. Therefore, results for Week 80, 88, 96, 104 were not reported.	units on a scale	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group669

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 2.5 mg	AEs	363	Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 5 mg	AEs	573	Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 10 mg	AEs	547	Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 2.5 mg	SAEs	47	Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 5 mg	SAEs	73	Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Tanezumab 10 mg	SAEs	96	Participants
Number of Participants With Abnormal Laboratory Findings	Tanezumab 2.5 mg		439	Participants
Number of Participants With Abnormal Laboratory Findings	Tanezumab 5 mg		679	Participants
Number of Participants With Abnormal Laboratory Findings	Tanezumab 10 mg		624	Participants
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings	Tanezumab 2.5 mg		14	Participants

1 to 10 of 669Source ClinicalTrials.gov

See all 669 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tanezumab 2.5 mg	525
Overall Study	STARTED	Tanezumab 5 mg	832
Overall Study	STARTED	Tanezumab 10 mg	790
Overall Study	Treated	Tanezumab 2.5 mg	522
Overall Study	Treated	Tanezumab 5 mg	832
Overall Study	Treated	Tanezumab 10 mg	788
Overall Study	COMPLETED	Tanezumab 2.5 mg	0
Overall Study	COMPLETED	Tanezumab 5 mg	0
Overall Study	COMPLETED	Tanezumab 10 mg	0
Overall Study	NOT COMPLETED	Tanezumab 2.5 mg	525

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events510

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Tanezumab 2.5 mg	7	522
other	Diarrhoea	Gastrointestinal disorders	Tanezumab 5 mg	18	832
other	Diarrhoea	Gastrointestinal disorders	Tanezumab 10 mg	8	788
other	Oedema peripheral	General disorders	Tanezumab 2.5 mg	22	522
other	Oedema peripheral	General disorders	Tanezumab 5 mg	52	832
other	Oedema peripheral	General disorders	Tanezumab 10 mg	57	788
other	Bronchitis	Infections and infestations	Tanezumab 2.5 mg	8	522
other	Bronchitis	Infections and infestations	Tanezumab 5 mg	9	832
other	Bronchitis	Infections and infestations	Tanezumab 10 mg	16	788
other	Nasopharyngitis	Infections and infestations	Tanezumab 2.5 mg	14	522

1 to 10 of 510Source ClinicalTrials.gov

See all 510 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tanezumab 2.5 mg
Total, all-cause mortality	Tanezumab 5 mg
Total, all-cause mortality	Tanezumab 10 mg
Total, other adverse events	Tanezumab 2.5 mg	280	522
Total, other adverse events	Tanezumab 5 mg	412	832
Total, other adverse events	Tanezumab 10 mg	408	788
Total, serious adverse events	Tanezumab 2.5 mg	47	522
Total, serious adverse events	Tanezumab 5 mg	73	832
Total, serious adverse events	Tanezumab 10 mg	96	788

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26554876	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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