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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089725

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Montgomery, Alabama, United States, 36117
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
Pfizer Investigational Site
Phoenix, Arizona, United States, 85029
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Burbank, California, United States, 91505
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
La Jolla, California, United States, 92037-1233
Pfizer Investigational Site
La Mesa, California, United States, 91942
Pfizer Investigational Site
National City, California, United States, 91950
Pfizer Investigational Site
Sacramento, California, United States, 95816
Pfizer Investigational Site
Santa Ana, California, United States, 92701
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
Englewood, Colorado, United States, 80110
United States, Connecticut
Pfizer Investigational Site
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20003
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33756
Pfizer Investigational Site
Crystal River, Florida, United States, 34429
Pfizer Investigational Site
Fleming Island, Florida, United States, 32003
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Jacksonville, Florida, United States, 32205
Pfizer Investigational Site
Largo, Florida, United States, 33777
Pfizer Investigational Site
Opa Locka, Florida, United States, 33054
Pfizer Investigational Site
Pinellas Park, Florida, United States, 33782
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33710
United States, Georgia
Pfizer Investigational Site
Woodstock, Georgia, United States, 30189
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60616
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67203
Pfizer Investigational Site
Wichita, Kansas, United States, 67208
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
United States, Louisiana
Pfizer Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
Pfizer Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site
Brockton, Massachusetts, United States, 02301
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48103
Pfizer Investigational Site
Troy, Michigan, United States, 48098
United States, Mississippi
Pfizer Investigational Site
Hattiesburg, Mississippi, United States, 39402
United States, Montana
Pfizer Investigational Site
Billings, Montana, United States, 59101
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
Pfizer Investigational Site
Omaha, Nebraska, United States, 64055
Pfizer Investigational Site
Omaha, Nebraska, United States, 68144
Pfizer Investigational Site
Omaha, Nebraska, United States, 68127
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New York
Pfizer Investigational Site
Roslyn, New York, United States, 11576
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209-3734
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27408
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Pfizer Investigational Site
Cincincinati, Ohio, United States, 45246
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45245
United States, Oklahoma
Pfizer Investigational Site
Norman, Oklahoma, United States, 73072
Pfizer Investigational Site
Norman, Oklahoma, United States, 73069
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
Lebanon, Pennsylvania, United States, 17042
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Pfizer Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Pfizer Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37604
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
Austin, Texas, United States, 78731
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
Houston, Texas, United States, 77036
Pfizer Investigational Site
Houston, Texas, United States, 77093
Pfizer Investigational Site
Houston, Texas, United States, 77034
Pfizer Investigational Site
Houston, Texas, United States, 77008
Pfizer Investigational Site
Kingwood, Texas, United States, 77339
Pfizer Investigational Site
Nassau Bay, Texas, United States, 77058
Pfizer Investigational Site
Plano, Texas, United States, 75075
Pfizer Investigational Site
San Angelo, Texas, United States, 76904
Pfizer Investigational Site
Sugar Land, Texas, United States, 77479
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Utah
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
Pfizer Investigational Site
Roanoke, Virginia, United States, 24018
United States, West Virginia
Pfizer Investigational Site
Clarksburg, West Virginia, United States, 26301
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:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014