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

NCT00960804 | Terminated Phase 3 Results

• 2 other identifiers: A4091040NERVE FUNCTION EXTENSION STUDY
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  A4091026: Baseline, A4091040: Week 24

Secondary Outcomes (3)

• Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24

  A4091026: Baseline, A4091040: Week 24

• Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24

  A4091026: Baseline, A4091040: Week 24

• Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24

  A4091026: Baseline, A4091040: Week 24

Other Outcomes (11)

• Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24

  A4091026: Baseline, A4091040: Week 24

• Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24

  A4091026: Baseline, A4091040: Week 24

• Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24

  A4091026: Baseline, A4091040: Week 24

Study Arms (3)

Tanezumab 5 mg

EXPERIMENTAL

Biological: Tanezumab

Tanezumab 10 mg

EXPERIMENTAL

Biological: Tanezumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tanezumab BIOLOGICAL

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

Tanezumab 5 mg

Placebo OTHER

IV, q 8 weeks, for up to 80 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Jem Research, LLC

Atlantis, Florida, 33462, United States

Location

Medical Specialists of the Palm Beaches

Atlantis, Florida, 33462, United States

Location

Clinical Physiology Associates, Clinical Study Center

Fort Myers, Florida, 33916, United States

Location

Harris Bonnette, MD

Fort Myers, Florida, 33919, United States

Location

Arthritis & Rheumatic Care Center

South Miami, Florida, 33143, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Neuroscience Consultants, LLC

South Miami, Florida, 33143, United States

Location

Asheville Imaging

Asheville, North Carolina, 28801, United States

Location

Biltmore Medical Associates

Asheville, North Carolina, 28801, United States

Location

Clinical Study Center of Asheville, LLC

Asheville, North Carolina, 28803, United States

Location

Asheville Neurology

Asheville, North Carolina, 28806-2287, United States

Location

Ohio Research Center

Toledo, Ohio, 43623, United States

Location

Blair Neurologic Associates

Altoona, Pennsylvania, 16601, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Coastal Carolina Research Center in Goose Creek

Goose Creek, South Carolina, 29445, United States

Location

Tidewater Neurology

Goose Creek, South Carolina, 29445, United States

Location

Neurodiagnostic Laboratories of San Antonio, Inc

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: February 15, 2010
• Primary Completion: November 11, 2010
• Study Completion: November 11, 2010
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

US (18)