Trial · NCT02528188

Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

NCT02528188, Phase 3, Completed, Pfizer; results first posted 2020-01-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee. Trials, record NCT02528188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02528188

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Trial

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

Title: Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
NCT number: NCT02528188
Status: Completed
Phases: Phase 3
Enrollment: 3,021 participants, actual
Lead sponsor: Pfizer
Conditions: Chronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
Interventions: NSAID, Tanezumab 2.5 mg, Tanezumab 5 mg
First posted: 2015-08-19
Last updated: 2020-01-10
Other registries' IDs: eudract:2012-003721-22
Results first posted: 2020-01-10
Limitations and caveats: 2 deaths occurred after end of study and are captured in All- cause mortality section.

Source ClinicalTrials.gov

Registered outcomes82

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Primary	Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Primary	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	Baseline, 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. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Primary	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16	Baseline, 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. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Primary	Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16	Baseline, Week 16	PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Secondary	Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome	Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Secondary	Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome	Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Secondary	Percentage of Participants With Individual Adjudicated Joint Safety Outcome	Baseline up to Week 80	Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW \>=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Secondary	Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome	Baseline up to Week 80	Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Secondary	Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.

1 to 10 of 82Source ClinicalTrials.gov

See all 82 registered outcomes

Outcomes82

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	percentage of participants	NUMBER
PRIMARY	Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	events per 1000 participant-years	NUMBER
PRIMARY	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	Baseline, Week 16	ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16	Baseline, Week 16	ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16	Baseline, Week 16	ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	percentage of participants	NUMBER
SECONDARY	Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	events per 1000 participant-years	NUMBER
SECONDARY	Percentage of Participants With Individual Adjudicated Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	percentage of participants	NUMBER
SECONDARY	Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	events per 1000 participant-years	NUMBER
SECONDARY	Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome	Baseline up to Week 80	Safety population included all participants treated with tanezumab or placebo SC.	percentage of participants	NUMBER

1 to 10 of 82Source ClinicalTrials.gov

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Results by group2,427

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

Outcome	Group	Value	Spread	Units
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	Tanezumab 2.5 mg	3.9	95% Confidence Interval 2.8 to 5.3	percentage of participants
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	Tanezumab 5 mg	7.1	95% Confidence Interval 5.6 to 8.9	percentage of participants
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome	NSAID	1.5	95% Confidence Interval 0.8 to 2.5	percentage of participants
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	Tanezumab 2.5 mg	38.3	95% Confidence Interval 28.0 to 52.5	events per 1000 participant-years
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	Tanezumab 5 mg	71.5	95% Confidence Interval 56.7 to 90.2	events per 1000 participant-years
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome	NSAID	14.8	95% Confidence Interval 8.9 to 24.6	events per 1000 participant-years
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	Tanezumab 2.5 mg	-3.22	Standard Error 0.11	units on a scale
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	Tanezumab 5 mg	-3.33	Standard Error 0.11	units on a scale
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16	NSAID	-3.07	Standard Error 0.11	units on a scale
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16	Tanezumab 2.5 mg	-3.27	Standard Error 0.11	units on a scale

1 to 10 of 2,427Source ClinicalTrials.gov

See all 2,427 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	1,008
Overall Study	STARTED	Tanezumab 5 mg	1,005
Overall Study	STARTED	NSAID	1,008
Overall Study	Treated	Tanezumab 2.5 mg	1,002
Overall Study	Treated	Tanezumab 5 mg	998
Overall Study	Treated	NSAID	996
Overall Study	COMPLETED	Tanezumab 2.5 mg	741
Overall Study	COMPLETED	Tanezumab 5 mg	729
Overall Study	COMPLETED	NSAID	757
Overall Study	NOT COMPLETED	Tanezumab 2.5 mg	267

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events351

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	Nasopharyngitis	Infections and infestations	Tanezumab 2.5 mg	57	1,002
other	Nasopharyngitis	Infections and infestations	Tanezumab 5 mg	67	998
other	Nasopharyngitis	Infections and infestations	NSAID	40	996
other	Upper respiratory tract infection	Infections and infestations	Tanezumab 2.5 mg	57	1,002
other	Upper respiratory tract infection	Infections and infestations	Tanezumab 5 mg	45	998
other	Upper respiratory tract infection	Infections and infestations	NSAID	59	996
other	Fall	Injury, poisoning and procedural complications	Tanezumab 2.5 mg	65	1,002
other	Fall	Injury, poisoning and procedural complications	Tanezumab 5 mg	52	998
other	Fall	Injury, poisoning and procedural complications	NSAID	46	996
other	Arthralgia	Musculoskeletal and connective tissue disorders	Tanezumab 2.5 mg	131	1,002

1 to 10 of 351Source ClinicalTrials.gov

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Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tanezumab 2.5 mg	4	1,002
Total, all-cause mortality	Tanezumab 5 mg	5	998
Total, all-cause mortality	NSAID	1	996
Total, other adverse events	Tanezumab 2.5 mg	301	1,002
Total, other adverse events	Tanezumab 5 mg	318	998
Total, other adverse events	NSAID	264	996
Total, serious adverse events	Tanezumab 2.5 mg	51	1,002
Total, serious adverse events	Tanezumab 5 mg	80	998
Total, serious adverse events	NSAID	46	996

Source ClinicalTrials.gov

Papers12

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33538113	DERIVED	PubMed
35217440	DERIVED	PubMed
35232805	DERIVED	PubMed
35351194	DERIVED	PubMed
35960482	DERIVED	PubMed
35980115	DERIVED	PubMed
36301512	DERIVED	PubMed
36474952	DERIVED	PubMed
37470295	DERIVED	PubMed
37652258	DERIVED	PubMed

1 to 10 of 12

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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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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