Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients

A Phase 3 study testing Tanezumab in people with Osteoarthritis, run by Pfizer at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Osteoarthritis
What is being tested?: Tanezumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 18 sitesUnited States
Study dates: 15 Feb 2010to 11 Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must consent in writing to participate in the study.
Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
Patients must have participated in the A4091026 study.

Who cannot join

Withdrawn from the A4091026 study for an adverse event or serious adverse event.
Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Blair Neurologic Associates
Altoona, Pennsylvania, 16601
Asheville Imaging
Asheville, North Carolina, 28801
Biltmore Medical Associates
Asheville, North Carolina, 28801
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, 28803
Asheville Neurology
Asheville, North Carolina, 28806-2287
Jem Research, LLC
Atlantis, Florida, 33462
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Clinical Physiology Associates, Clinical Study Center
Fort Myers, Florida, 33916
Harris Bonnette, MD
Fort Myers, Florida, 33919
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, 29445
Tidewater Neurology
Goose Creek, South Carolina, 29445
Neurodiagnostic Laboratories of San Antonio, Inc
San Antonio, Texas, 78229
Radiant Research, Inc.
San Antonio, Texas, 78229
Arthritis & Rheumatic Care Center
South Miami, Florida, 33143
Miami Research Associates
South Miami, Florida, 33143
Neuroscience Consultants, LLC
South Miami, Florida, 33143
Ohio Research Center
Toledo, Ohio, 43623

Other trials in United States

About this study

Official title: A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, LONG-TERM SAFETY STUDY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves

Read the detailed description

This study was terminated on 11 Nov 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.

Conditions: Osteoarthritis
Being tested: Tanezumab, Placebo
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TanezumabBiological
IV, 5 mg dose, q 8 weeks, for up to 80 weeks
TanezumabBiological
IV, 10 mg dose, q 8 weeks, for up to 80 weeks
PlaceboOther
IV, q 8 weeks, for up to 80 weeks

Study groups in NCT00960804
Study group	Role	What they receive
Tanezumab 5 mg	Experimental	Not described Receives: Biological: Tanezumab
Tanezumab 10 mg	Experimental	Not described Receives: Biological: Tanezumab
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.
Measured: A4091026: Baseline, A4091040: Week 24

Secondary outcomes (3)

Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24
NIS-LL:assess muscle weakness, reflexes, sensation;scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion,hip and knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors) scored on scale 0(normal) to 4(paralysis),higher score=greater weakness. Components of reflexes(quadriceps femoris,triceps surae);sensation (touch pressure,pin-prick,vibration,joint position) scored 0=normal,1=decreased, or 2=absent. NIS-LL score: sum of scores of NIS items 17-24, 28-29 and 34-37. Total possible NIS-LL score range 0-88,high score=more impairment.
Measured: A4091026: Baseline, A4091040: Week 24
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24
NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Measured: A4091026: Baseline, A4091040: Week 24
Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24
NSC score is the number of the 38 symptom questions where the participants indicated experiencing the symptom to any severity. Total score range: 0 to 38 where higher score indicated more symptoms.
Measured: A4091026: Baseline, A4091040: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201011 Nov 2010

First posted18 Aug 2009 (estimated)
Study start15 Feb 2010
Primary completion11 Nov 2010
Study completion11 Nov 2010

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00960804
Sponsor's protocol ID: A4091040
Other IDs: NERVE FUNCTION EXTENSION STUDY
Status last verified: Nov 2020
First submitted: 17 Aug 2009
Last updated: 8 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
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Osteoarthritis, Knee
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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, LONG-TERM SAFETY STUDY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
ClinicalTrials.gov ID: NCT00960804
Acronym / sponsor ID: A4091040
Conditions: Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 21 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Feb 2010 (actual)
Primary completion: 11 Nov 2010 (actual)
Study completion: 11 Nov 2010 (actual)
First posted: 18 Aug 2009 (estimated)
Results: Posted 8 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Tanezumab 5 mg	Experimental	Biological: Tanezumab
Tanezumab 10 mg	Experimental	Biological: Tanezumab
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients must consent in writing to participate in the study.
Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
Patients must have participated in the A4091026 study.

Key exclusion criteria (3 listed)

Withdrawn from the A4091026 study for an adverse event or serious adverse event.
Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TanezumabIV, 5 mg dose, q 8 weeks, for up to 80 weeks	Biological	Tanezumab 5 mg
TanezumabIV, 10 mg dose, q 8 weeks, for up to 80 weeks	Biological	Tanezumab 10 mg
PlaceboIV, q 8 weeks, for up to 80 weeks	Other	Placebo

Primary outcome

Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24
Time frame: A4091026: Baseline, A4091040: Week 24
5NC(nd)+HRdb(nd)composite score included 5 Nerve Conduction Studies(NCS)attributes(peroneal motor nerve distal latency [MNDL],peroneal nerve compound muscle action potential[CMAP],peroneal motor nerve conduction velocity[MNCV],tibial MNDL,sural sensory nerve action potential amplitude [SNAP])and HRdb value. Values of attributes scored as percentile(calculated from distribution of normal values corresponding to participant's baseline demographic characteristics),then expressed as normal deviate(nd)score based on standard normal distribution.Score >0=worse response,less than(<)0=better response compared to normal matched population.Score change>0=worsening,<0=improvement compared to baseline.2 neurological visits(NVs) were conducted both at baseline and Week 24. NCS measurements were collected once at each NV.HRdb measurements were collected twice and highest nd score was selected at each NV. Mean of selected measurements at each NV was calculated to obtain Baseline and Week 24 values.

3 secondary outcomes

Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24
Time frame: A4091026: Baseline, A4091040: Week 24
Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24
Time frame: A4091026: Baseline, A4091040: Week 24
Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24
Time frame: A4091026: Baseline, A4091040: Week 24

Results and safety

Results posted to the registry on 8 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tanezumab 5 mg + Standard of Care	7	0
Tanezumab 10 mg + Standard of Care	4	0
Placebo + Standard of Care	10	0

Primary outcome: Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24

Time frame: A4091026: Baseline, A4091040: Week 24. Mean (Standard Deviation). Unit: normal deviate score

Measure	Tanezumab 5 mg + Standard of Care n = 7	Tanezumab 10 mg + Standard of Care n = 4	Placebo + Standard of Care n = 10
Baseline	1.37 (3.19)	2.96 (1.02)	0.31 (2.76)
Change at Week 24	0.28 (2.57)	1.79 (2.70)	-1.40 (2.83)

Population analysed: Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of intravenous study medication during this study A4091040. Missing values were imputed using last observation carried forward (LOCF) method.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tanezumab 5 mg + Standard of Care	1 of 7 (14.3%)	6 of 7 (85.7%)	Not reported
Tanezumab 10 mg + Standard of Care	1 of 4 (25%)	3 of 4 (75%)	Not reported
Placebo + Standard of Care	0 of 10 (0%)	4 of 10 (40%)	Not reported

Limitations and caveats (from the sponsor): Due to FDA-imposed clinical hold, enrollment stopped prematurely, thus inadequate power to fulfill primary objectives.Efficacy data beyond Week 32 not collected.Change in planned analysis added results of \>=70%, 90% reduction in WOMAC pain subscale.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tanezumab in people with Osteoarthritis, run by Pfizer at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate and Heart Rate-Deep Breathing, Normal Deviate (5NC [nd] + HRdb-[nd]) Composite Score at Week 24 (time frame: A4091026: Baseline, A4091040: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00960804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.