18 and older, any sex, with Osteoarthritis, Knee or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16Primary· 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 osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Group
Value
95% CI
Placebo
-2.64
± 0.23
Tanezumab 2.5 mg
-3.23
± 0.23
Tanezumab 2.5/5 mg
-3.37
± 0.22
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16Primary· 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 osteoarthritis. 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 osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimu
Group
Value
95% CI
Placebo
-2.56
± 0.22
Tanezumab 2.5 mg
-3.22
± 0.22
Tanezumab 2.5/5 mg
-3.45
± 0.22
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16Primary· Baseline, Week 16
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, 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 n
Group
Value
95% CI
Placebo
-0.65
± 0.08
Tanezumab 2.5 mg
-0.87
± 0.08
Tanezumab 2.5/5 mg
-0.90
± 0.08
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12Secondary· Baseline, Weeks 2, 4, 8 and 12
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change at Week 2
Group
Value
95% CI
Placebo
-2.20
± 0.21
Tanezumab 2.5 mg
-2.87
± 0.21
Tanezumab 2.5/5 mg
-2.89
± 0.21
Change at Week 4
Group
Value
95% CI
Placebo
-2.40
± 0.21
Tanezumab 2.5 mg
-3.28
± 0.21
Tanezumab 2.5/5 mg
-3.27
± 0.21
Change at Week 8
Group
Value
95% CI
Placebo
-2.61
± 0.21
Tanezumab 2.5 mg
-3.20
± 0.21
Tanezumab 2.5/5 mg
-3.02
± 0.21
Change at Week 12
Group
Value
95% CI
Placebo
-2.83
± 0.23
Tanezumab 2.5 mg
-3.61
± 0.22
Tanezumab 2.5/5 mg
-3.69
± 0.22
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24Secondary· Baseline, Week 24
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Baseline
Group
Value
95% CI
Placebo
7.30
± 1.15
Tanezumab 2.5 mg
7.08
± 1.16
Tanezumab 2.5/5 mg
7.33
± 1.26
Change at Week 24
Group
Value
95% CI
Placebo
-3.07
± 2.43
Tanezumab 2.5 mg
-2.80
± 2.50
Tanezumab 2.5/5 mg
-2.95
± 2.49
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12Secondary· Baseline, Weeks 2, 4, 8 and 12
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimu
Change at Week 2
Group
Value
95% CI
Placebo
-2.14
± 0.21
Tanezumab 2.5 mg
-2.89
± 0.21
Tanezumab 2.5/5 mg
-3.05
± 0.21
Change at Week 4
Group
Value
95% CI
Placebo
-2.28
± 0.21
Tanezumab 2.5 mg
-3.30
± 0.21
Tanezumab 2.5/5 mg
-3.38
± 0.21
Change at Week 8
Group
Value
95% CI
Placebo
-2.55
± 0.21
Tanezumab 2.5 mg
-3.17
± 0.21
Tanezumab 2.5/5 mg
-3.12
± 0.21
Change at Week 12
Group
Value
95% CI
Placebo
-2.75
± 0.22
Tanezumab 2.5 mg
-3.61
± 0.22
Tanezumab 2.5/5 mg
-3.80
± 0.22
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24Secondary· Baseline, Week 24
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. 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 osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimu
Baseline
Group
Value
95% CI
Placebo
7.38
± 1.12
Tanezumab 2.5 mg
7.18
± 1.11
Tanezumab 2.5/5 mg
7.39
± 1.18
Change at Week 24
Group
Value
95% CI
Placebo
-3.03
± 2.37
Tanezumab 2.5 mg
-2.85
± 2.51
Tanezumab 2.5/5 mg
-3.01
± 2.46
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12Secondary· Baseline, Weeks 2, 4, 8 and 12
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, 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 n
Change at Week 2
Group
Value
95% CI
Placebo
-0.74
± 0.07
Tanezumab 2.5 mg
-0.91
± 0.07
Tanezumab 2.5/5 mg
-0.87
± 0.07
Change at Week 4
Group
Value
95% CI
Placebo
-0.75
± 0.07
Tanezumab 2.5 mg
-1.01
± 0.07
Tanezumab 2.5/5 mg
-0.97
± 0.07
Change at Week 8
Group
Value
95% CI
Placebo
-0.82
± 0.07
Tanezumab 2.5 mg
-0.97
± 0.07
Tanezumab 2.5/5 mg
-0.91
± 0.07
Change at Week 12
Group
Value
95% CI
Placebo
-0.83
± 0.08
Tanezumab 2.5 mg
-1.01
± 0.08
Tanezumab 2.5/5 mg
-1.11
± 0.08
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24Secondary· Baseline, Week 24
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, 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 n
Baseline
Group
Value
95% CI
Placebo
3.46
± 0.57
Tanezumab 2.5 mg
3.42
± 0.60
Tanezumab 2.5/5 mg
3.53
± 0.62
Change at Week 24
Group
Value
95% CI
Placebo
-0.87
± 0.85
Tanezumab 2.5 mg
-0.72
± 0.93
Tanezumab 2.5/5 mg
-0.91
± 1.03
Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder IndexSecondary· Weeks 2, 4, 8, 12, 16 and 24
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (\>=) 50 percent and greater or equal to (\>=) 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher s
Week 2
Group
Value
95% CI
Placebo
50.4
Tanezumab 2.5 mg
65.4
Tanezumab 2.5/5 mg
67.4
Week 4
Group
Value
95% CI
Placebo
58.6
Tanezumab 2.5 mg
74.0
Tanezumab 2.5/5 mg
74.7
Week 8
Group
Value
95% CI
Placebo
61.6
Tanezumab 2.5 mg
67.5
Tanezumab 2.5/5 mg
69.5
Week 12
Group
Value
95% CI
Placebo
66.4
Tanezumab 2.5 mg
77.5
Tanezumab 2.5/5 mg
81.1
Week 16
Group
Value
95% CI
Placebo
65.1
Tanezumab 2.5 mg
72.7
Tanezumab 2.5/5 mg
79.0
Week 24
Group
Value
95% CI
Placebo
68.1
Tanezumab 2.5 mg
66.5
Tanezumab 2.5/5 mg
68.8
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% ResponseSecondary· Week 2, 4, 8, 12, 16 and 24
Percentage of participants with reduction in WOMAC pain intensity of at least (\>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48
Week 2: At least 30% reduction
Group
Value
95% CI
Placebo
38.8
Tanezumab 2.5 mg
56.3
Tanezumab 2.5/5 mg
56.2
Week 2: At least 50% reduction
Group
Value
95% CI
Placebo
22.8
Tanezumab 2.5 mg
38.5
Tanezumab 2.5/5 mg
38.2
Week 2: At least 70% reduction
Group
Value
95% CI
Placebo
15.5
Tanezumab 2.5 mg
25.5
Tanezumab 2.5/5 mg
24.5
Week 2: At least 90% reduction
Group
Value
95% CI
Placebo
6.9
Tanezumab 2.5 mg
13.4
Tanezumab 2.5/5 mg
9.4
Week 4: At least 30% reduction
Group
Value
95% CI
Placebo
47.0
Tanezumab 2.5 mg
65.4
Tanezumab 2.5/5 mg
63.5
Week 4: At least 50% reduction
Group
Value
95% CI
Placebo
30.2
Tanezumab 2.5 mg
48.5
Tanezumab 2.5/5 mg
48.5
Week 4: At least 70% reduction
Group
Value
95% CI
Placebo
16.4
Tanezumab 2.5 mg
29.4
Tanezumab 2.5/5 mg
29.6
Week 4: At least 90% reduction
Group
Value
95% CI
Placebo
8.2
Tanezumab 2.5 mg
16.0
Tanezumab 2.5/5 mg
15.5
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16Secondary· Baseline to 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 osteoarthritis of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (extreme pain), wher
>=0%
Group
Value
95% CI
Placebo
82.3
Tanezumab 2.5 mg
87.4
Tanezumab 2.5/5 mg
88.4
>=10%
Group
Value
95% CI
Placebo
79.3
Tanezumab 2.5 mg
81.8
Tanezumab 2.5/5 mg
85.4
>=20%
Group
Value
95% CI
Placebo
65.5
Tanezumab 2.5 mg
74.0
Tanezumab 2.5/5 mg
79.0
>=30%
Group
Value
95% CI
Placebo
54.7
Tanezumab 2.5 mg
68.0
Tanezumab 2.5/5 mg
70.4
>=40%
Group
Value
95% CI
Placebo
45.7
Tanezumab 2.5 mg
63.2
Tanezumab 2.5/5 mg
66.1
>=50%
Group
Value
95% CI
Placebo
37.9
Tanezumab 2.5 mg
54.5
Tanezumab 2.5/5 mg
57.1
>=60%
Group
Value
95% CI
Placebo
31.5
Tanezumab 2.5 mg
44.2
Tanezumab 2.5/5 mg
44.6
>=70%
Group
Value
95% CI
Placebo
25.0
Tanezumab 2.5 mg
34.6
Tanezumab 2.5/5 mg
36.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Week 40 (end of study).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 9/232 (4%)
Deaths: 0/232
Tanezumab 2.5 mg
Serious: 7/231 (3%)
Deaths: 0/231
Tanezumab 2.5/5 mg
Serious: 11/233 (5%)
Deaths: 2/233
Serious adverse events (28 terms)
Reaction
System
Placebo
Tanezumab 2.5 mg
Tanezumab 2.5/5 mg
Chest pain
General disorders
—
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
—
Iron deficiency anaemia
Blood and lymphatic system disorders
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Arthritis bacterial
Infections and infestations
—
—
—
Pneumonia
Infections and infestations
—
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
—
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Non-small cell lung cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Nephrolithiasis
Renal and urinary disorders
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
Gastric ulcer
Gastrointestinal disorders
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
Abdominal hernia infection
Infections and infestations
—
—
—
Appendicitis
Infections and infestations
—
—
—
Bacterial infection
Infections and infestations
—
—
—
Cellulitis
Infections and infestations
—
—
—
Spondylolisthesis
Musculoskeletal and connective tissue disorders
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Haemorrhagic stroke
Nervous system disorders
—
—
—
Completed suicide
Psychiatric disorders
—
—
—
Other adverse events (315 terms — click to expand)
The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02528188 — Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
· Phase 3
· completed
NCT00994890 — A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 3 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02697773.