Clinical trial NCT01127893: Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 1
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: An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks

Detailed description: This study was terminated on 29 September 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:

* Must have participated in specific Phase 3 parent study

Exclusion Criteria:

* Failed screening for parent study, pregnant women, lactating mothers

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Early Termination (Day 107)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to Early Termination (Day 107)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Early Termination (Day 107)
measure: Number of Participants With Neurologic Examination Abnormalities
timeFrame: Baseline up to Early Termination (Day 107)
measure: Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
timeFrame: Baseline up to Early Termination (Day 107)
measure: Number of Participants With Injection Site Reactions
timeFrame: Baseline up to Early Termination (Day 107)
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Percentage of Participants With Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Percentage of Participants With Improvement of At Least (>=) 2 Point in Patient Global Assessment (PGA) of Osteoarthritis
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64
timeFrame: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 64
measure: Number of Participants Who Received Concomitant Analgesic Medication for Osteoarthritis Treatment
timeFrame: Baseline up to Day 107 (Early Termination)
measure: Days Per Week of Concomitant Analgesic Medication Usage for Osteoarthritis Treatment
timeFrame: Baseline up to Week 64
measure: Tanezumab Plasma Concentration
timeFrame: Pre-dose on Week 8, 24, 40; Week 56, 64
measure: Nerve Growth Factor (NGF) Serum Concentration
timeFrame: Pre-dose on Week 8, 24, 40; Week 56, 64
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Triwest Research Associates
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: