Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01089725
First received: March 11, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.


Condition Intervention Phase
Osteoarthritis
Arthritis
Pain
Biological: Placebo IV
Biological: Placebo SC
Biological: Tanezumab SC
Biological: Tanezumab IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of Subcutaneous Administration Of Tanezumab In Patients With Osteoarthritis Of The Knee

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from Baseline to Week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain subscale [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in the WOMAC Physical Function subscale [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 16 in the Patient Global Assessment of Osteoarthritis [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Pain subscale change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • WOMAC Physical Function subscale change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis (5-point Likert scale) change from Baseline to Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) and OsteoArthritis Research Society International (OARSI) responder index at Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Treatment Response: Reduction in the WOMAC Pain subscale of greater than or equal to: 30%, 50%, 70%, and 90% at Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Cumulative distribution of percent change from Baseline in the WOMAC Pain subscale score to Weeks 1, 2, 4, 8, 12 and 16 (endpoint for summary only) [ Time Frame: Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • Treatment Response: Improvement of greater than or equal to 2 points in Patient Global Assessment of Osteoarthritis at Weeks 1, 2, 4, 8, 12, and 16 • [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Average pain score in the index knee change from Baseline to Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • WOMAC Stiffness subscale change from Baseline to Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • WOMAC Average change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface, change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs, change from Baseline to Weeks 1, 2, 4, 8, 12 and 16 [ Time Frame: Baseline to Weeks 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
  • SF-36v2TM Health Survey change from Baseline to Week 16 (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Time to discontinuation due to Lack of Efficacy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of patients who use rescue medication during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Number of days of rescue medication use during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Amount (mg) of rescue medication taken during Weeks 1, 2, 4, 8, 12, and 16 [ Time Frame: Weeks 1, 2, 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory testing (chemistry, hematology, urinalysis) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Neurologic exam (Neuropathy Impairment Score [NIS]) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Anti Drug Antibody (ADA) assessments predose at Baseline, Week 8 and 16, and at Week 24, or Early Termination [ Time Frame: Baseline, Week 8 and 16, and at Week 24, or Early Termination ] [ Designated as safety issue: Yes ]
  • Physical examinations [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Injection/infusion site reactions [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Measurement of plasma tanezumab concentrations at Baseline (predose), Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16, and Week 24 or early termination [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16, and Week 24 ] [ Designated as safety issue: No ]
  • Measurement of serum total and/or bound and/or free NGF concentrations at Baseline (predose), Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16 and Week 24 or early termination [ Time Frame: Baseline , Week 1, Week 2, Week 4, Week 8 (predose), Week 12, Week 16 and Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 385
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Biological: Placebo IV
1 ml of placebo administered SC and IV once every 8 weeks.
Biological: Placebo SC
1 ml of placebo administered SC and IV once every 8 weeks.
Experimental: 2.5 mg tanezumab SC and placebo IV Biological: Tanezumab SC
1 ml tanezumab injection SC administered every 8 weeks
Biological: Placebo IV
1 ml placebo administered IV every 8 weeks
Experimental: 5 mg tanezumab SC and placebo IV Biological: Tanezumab SC
1 ml tanezumab injection SC administered every 8 weeks
Biological: Placebo IV
1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab SC and placebo IV Biological: Tanezumab SC
1 ml tanezumab injection SC administered every 8 weeks
Biological: Placebo IV
1ml placebo administered IV every 8 weeks
Experimental: 10 mg tanezumab IV Biological: Tanezumab IV
1 ml tanezumab injection IV administered every 8 weeks
Biological: Placebo SC
1ml placebo administered SC every 8 weeks

Detailed Description:

This study was terminated on 08 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
  • 18 years of age or greater
  • Two methods of birth control one of which must be barrier if of childbearing potential
  • Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria:

  • Pregnancy or wishing to be pregnant during the course of the study, lactating women
  • Body Mass Index (BMI) greater than 39
  • Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
  • Previous exposure to a Nerve Growth Factor (NGF) antibody
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089725

  Show 80 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01089725     History of Changes
Other Study ID Numbers: A4091027
Study First Received: March 11, 2010
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
safety
efficacy
parallel group
double-blind
multicenter
injection
infusion
osteoarthritis
bridging
subcutaneous
intravenous
tanezumab

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014