Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)
  • WOMAC Physical Function subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities Index (WOMAC) Pain subscale [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00809354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 9, 2009)
  • Adverse events [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: No ]
  • Measurement of plasma tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ] [ Designated as safety issue: No ]
  • WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
  • Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ] [ Designated as safety issue: Yes ]
  • Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: Yes ]
  • Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)
  • Adverse events [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • SF-36v2 Health Survey (8 domains plus Physical Component Summary and Mental Component Summary) [ Time Frame: Weeks 12, 24, 40 and 56 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Arthritis [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: No ]
  • Measurement of plama tanezumab concentrations [ Time Frame: Weeks 16, 24, 40 and 56 ] [ Designated as safety issue: No ]
  • WOMAC pain, physical function and stiffness subscales [ Time Frame: Weeks 2, 4, 8, 12, 24,32, 40, 48 and 56 ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]
  • Radiographic assessment of index joint (knee or hip) [ Time Frame: Screening period and Week 56 ] [ Designated as safety issue: Yes ]
  • Safety (laboratories for chemistry, hematology urinalysis, ECGs, physical exams, vital signs, neurologic exams, serum anti-drug antibody assessments [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • Pregnancy tests (where applicable) [ Time Frame: Weeks 8, 16, 24, 32, 40, 48 and 56 ] [ Designated as safety issue: Yes ]
  • Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Weeks 24 and 56 ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJELong-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Official Title  ICMJEA Phase 3, Multi-Center, Randomized, Double-Blind, Controlled Study Of The Long-Term Analgesic Efficacy And Safety of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Brief Summary

The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Osteoarthritis
  • Arthritis
Intervention  ICMJE
  • Drug: NSAID
    IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
  • Biological: tanezumab
    IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
  • Biological: tanezumab
    IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
  • Biological: tanezumab
    IV tanezumab 5 mg every 8 weeks (through Week 48)
  • Drug: NSAID
    Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
  • Biological: tanezumab
    IV tanezumab 10 mg every 8 weeks (through Week 48)
Study Arms / Comparison Groups
  • IV Placebo + NSAID: Active Comparator
    Oral NSAID
    Intervention: Drug: NSAID
  • Tanezumab 5 mg: Experimental
    IV tanezumab 5 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Tanezumab 10 mg: Experimental
    IV tanezumab 10 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Tanezumab 5 mg + NSAID: Experimental
    IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
    Interventions:
    • Biological: tanezumab
    • Drug: NSAID
  • Tanezumab 10 mg + NSAID: Experimental
    IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
    Interventions:
    • Biological: tanezumab
    • Drug: NSAID

Recruitment Information

Estimated Enrollment  ICMJE2500
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
  • Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
  • Pain level and function levels as required by the protocol at Screening and Baseline.
  • Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
  • Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  • Pregnant women.
  • BMI greater than 39.
  • Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
  • Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
  • Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
  • History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
  • At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
  • Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
  • Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Canada,   Colombia,   India,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Russian Federation,   South Africa,   Spain,   Ukraine

Administrative Information

NCT ID  ICMJENCT00809354
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA4091025
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer