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

Phase 3

Terminated

Conditions: Osteoarthritis

Interventions: Other: Placebo
Biological: Tanezumab

Registration Number: NCT00960804

Lead Sponsor: Pfizer

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

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 21

Inclusion Criteria

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.

Exclusion Criteria

Withdrawn from the A4091026 study for an adverse event or serious adverse event.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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tanezumab 5 mg	Tanezumab	-
Tanezumab 10 mg	Tanezumab	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (18): Jem Research, LLC
🇺🇸
Atlantis, Florida, United States
Medical Specialists of the Palm Beaches
🇺🇸
Atlantis, Florida, United States
Miami Research Associates
🇺🇸
South Miami, Florida, United States
Arthritis & Rheumatic Care Center
🇺🇸
South Miami, Florida, United States
Neuroscience Consultants, LLC
🇺🇸
South Miami, Florida, United States
Ohio Research Center
🇺🇸
Toledo, Ohio, United States
Blair Neurologic Associates
🇺🇸
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Coastal Carolina Research Center in Goose Creek
🇺🇸
Goose Creek, South Carolina, United States
Tidewater Neurology
🇺🇸
Goose Creek, South Carolina, United States
Clinical Physiology Associates, Clinical Study Center
🇺🇸
Fort Myers, Florida, United States
Harris Bonnette, MD
🇺🇸
Fort Myers, Florida, United States
Neurodiagnostic Laboratories of San Antonio, Inc
🇺🇸
San Antonio, Texas, United States
Asheville Imaging
🇺🇸
Asheville, North Carolina, United States
Clinical Study Center of Asheville, LLC
🇺🇸
Asheville, North Carolina, United States
Biltmore Medical Associates
🇺🇸
Asheville, North Carolina, United States
Asheville Neurology
🇺🇸
Asheville, North Carolina, United States
Radiant Research, Inc.
🇺🇸
San Antonio, Texas, United States