Adults 40 to 75, any sex, with Osteoarthritis or OA Knee Pain. 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.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Baseline up to 12 weeks after last dose of study drug
AE: any untoward medical occurrence in a participant who received study drug 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 drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. A
AEs
Group
Value
95% CI
Tanezumab 50 mcg/kg
168
SAEs
Group
Value
95% CI
Tanezumab 50 mcg/kg
8
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from the five individual questions scored on a visual analog scale (VAS) of 0 to 100, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 100, where higher scores indicate higher pain.
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from the 2 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC stiffness subscale score is 0 to 100, where higher scores indicate worse function. Stiffness is defined as a sensation of decreased ease in movement of knee.
Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on VAS of 0 to 100, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 100, where higher scores indicate worse function.
Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Participants answered: "In the past 24 hours, how much pain have you had in your index knee caused by your osteoarthritis?" Participants responded by using a VAS of 0 to 100, where 0 = no pain and 100 = extreme pain, higher scores indicated more pain.
Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a VAS of 0 to 100, where 0 = very poor and 100 = very good, where higher scores indicated better health condition.
Number of Participants With Response to Participant Satisfaction QuestionnaireSecondary· A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Participants answered: "Overall, how satisfied are you with the study drug treatment you received as part of this study?" Participants responded by selecting the most appropriate among the following responses: not at all satisfied, a little satisfied, somewhat satisfied, and very satisfied.
Baseline: Very Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
191
Baseline: Somewhat Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
36
Baseline: A Little Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
14
Baseline: Not at all Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
26
Week 4: Very Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
189
Week 4: Somewhat Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
57
Week 4: A Little Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
11
Week 4: Not at all Satisfied
Group
Value
95% CI
Tanezumab 50 mcg/kg
2
Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72Secondary· A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). The total score for each section and 2 component scores are an average of the individual question scores, which are scaled from 0 to 100, where 0=lowest level of functioning and 100=highest level of functioning, higher scores indicated better functioning .
Baseline: General Health
Group
Value
95% CI
Tanezumab 50 mcg/kg
75.9
± 16.97
Baseline: Physical Function
Group
Value
95% CI
Tanezumab 50 mcg/kg
45.4
± 21.40
Baseline: Role Physical
Group
Value
95% CI
Tanezumab 50 mcg/kg
63.3
± 23.61
Baseline: Bodily Pain
Group
Value
95% CI
Tanezumab 50 mcg/kg
50.4
± 19.86
Baseline: Vitality
Group
Value
95% CI
Tanezumab 50 mcg/kg
63.2
± 18.24
Baseline: Social Functioning
Group
Value
95% CI
Tanezumab 50 mcg/kg
83.9
± 19.88
Baseline: Role Emotional
Group
Value
95% CI
Tanezumab 50 mcg/kg
81.3
± 22.54
Baseline: Mental Health
Group
Value
95% CI
Tanezumab 50 mcg/kg
82.8
± 13.45
Percentage of Participants Who Discontinued the StudySecondary· A4091009: Baseline up to 12 weeks after last dose of study drug
Group
Value
95% CI
Tanezumab 50 mcg/kg
34.9
Median Time in Study A4091009Secondary· A4091009: Baseline up to 12 weeks after last dose of study drug
Median time of participation in the study for all the participants was evaluated.
Group
Value
95% CI
Tanezumab 50 mcg/kg
198
1.0 – 484.0
Change From A4091009 (NCT00399490) Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, and End of StudySecondary· A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, End of Study (12 weeks after the last dose of study drug)
HVLT-R: instrument consisting of 12 noun list, used to measure verbal learning and memory (recognition and recall). List was read to participant, who then attempted to recall as many words as possible. The examiner recorded each response. Task was repeated 2 more times, for total of 3 learning trials. After delay interval of 20-25 minutes, delayed recall trial was administered. Total score (TS) = sum of 3 learning trial scores of 12 word each, ranged: 0 (no memory) to 36 (best memory), where higher scores indicated better memory. Delayed recall (DR) = number of words recalled in delayed recall
Baseline: TS
Group
Value
95% CI
Tanezumab 50 mcg/kg
31.5
± 3.75
Baseline: DR
Group
Value
95% CI
Tanezumab 50 mcg/kg
11.2
± 1.44
Change at Week 4: TS
Group
Value
95% CI
Tanezumab 50 mcg/kg
-0.0
± 3.44
Change at Week 4: DR
Group
Value
95% CI
Tanezumab 50 mcg/kg
-0.0
± 1.16
Change at Week 8: TS
Group
Value
95% CI
Tanezumab 50 mcg/kg
-0.2
± 3.43
Change at Week 8: DR
Group
Value
95% CI
Tanezumab 50 mcg/kg
0.1
± 1.45
Change at Week 16: TS
Group
Value
95% CI
Tanezumab 50 mcg/kg
0.1
± 3.20
Change at Week 16: DR
Group
Value
95% CI
Tanezumab 50 mcg/kg
0.1
± 1.33
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tanezumab 50 mcg/kg
Serious: 8/281 (3%)
Deaths: —
Serious adverse events (10 terms)
Reaction
System
Tanezumab 50 mcg/kg
Myocardial infarction
Cardiac disorders
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
Joint dislocation
Injury, poisoning and procedural complications
—
Radius fracture
Injury, poisoning and procedural complications
—
Upper limb fracture
Injury, poisoning and procedural complications
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Multiple myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· recruiting
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· active not recruiting
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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: 2 February 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/NCT00399490.