Clinical trial NCT00960804: Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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* Withdrawn from the A4091026 study for an adverse event or serious adverse event.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.

Primary outcomes:
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
timeFrame: A4091026: Baseline, A4091040: Week 24
Secondary outcomes:
measure: Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in Neuropathy Impairment Score (NIS) at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in Neuropathy Symptoms and Change (NSC) Score at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
Other outcomes:
measure: Change From A4091026 (NCT00863772) Baseline in 5 Nerve Conduction Tests, Normal Deviate (5NC [nd]) Score at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in Heart Rate-Deep Breathing, Normal Deviate (HRdb, [nd]) Score at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in Intraepidermal Nerve Fiber Density (IENF) at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Domain Scores at Week 8, 16, 24 and 32
timeFrame: A4091026: Baseline, A4091040: Week 8, 16, 24, 32
measure: Change From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 8, 16, 24 and 32
timeFrame: A4091026: Baseline, A4091040: Week 8, 16, 24, 32
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: Week 8, 16, 24
measure: Change From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 8, 16 and 24
timeFrame: A4091026: Baseline, A4091040: Week 8, 16, 24
measure: Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From A4091026 (NCT00863772) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Week 8, 16, 24, 32
measure: Percentage of Participants With Improvement of At Least 2 Points From A4091026 (NCT00863772) Baseline in Patient's Global Assessment (PGA) of Osteoarthritis
timeFrame: Week 8, 16, 24, 32
measure: Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
measure: Change From A4091026 (NCT00863772) Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 24
timeFrame: A4091026: Baseline, A4091040: Week 24
Locations:
city: Atlantis
country: United States
facility: Jem Research, LLC
state: Florida
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, Clinical Study Center
state: Florida
city: Fort Myers
country: United States
facility: Harris Bonnette, MD
state: Florida
city: South Miami
country: United States
facility: Arthritis & Rheumatic Care Center
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: South Miami
country: United States
facility: Neuroscience Consultants, LLC
state: Florida
city: Asheville
country: United States
facility: Asheville Imaging
state: North Carolina
city: Asheville
country: United States
facility: Biltmore Medical Associates
state: North Carolina
city: Asheville
country: United States
facility: Clinical Study Center of Asheville, LLC
state: North Carolina
city: Asheville
country: United States
facility: Asheville Neurology
state: North Carolina
city: Toledo
country: United States
facility: Ohio Research Center
state: Ohio
city: Altoona
country: United States
facility: Blair Neurologic Associates
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Goose Creek
country: United States
facility: Coastal Carolina Research Center in Goose Creek
state: South Carolina
city: Goose Creek
country: United States
facility: Tidewater Neurology
state: South Carolina
city: San Antonio
country: United States
facility: Neurodiagnostic Laboratories of San Antonio, Inc
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: