Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With NSAIDs Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip - Full Text View

Sponsors and Collaborators:	Pfizer Pharmanet Development Group
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00809354

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Arthritis	Drug: NSAID Biological: tanezumab	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Immunoglobulins Globulin, Immune Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Naproxen Naproxen sodium Nerve growth factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	2500
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IV Placebo + NSAID: Active Comparator Oral NSAID	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
Tanezumab 5 mg: Experimental IV tanezumab 5 mg every 8 weeks (through Week 48)	Biological: tanezumab IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
Tanezumab 10 mg: Experimental IV tanezumab 10 mg every 8 weeks (through Week 48)	Biological: tanezumab IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
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	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
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	Biological: tanezumab IV tanezumab 10 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

Eligibility

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

Criteria

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 1000 mg/day (either 500 mg BID or sustained release 1000 mg QD) 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 moths 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809354

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Pharmanet Development Group

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091025
Study First Received:	December 16, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00809354
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

monoclonal antibody, nerve growth factor (NGF), anti-NGF, tanezumab, PF-04383119, RN624, osteoarthritis (OA)

Study placed in the following topic categories:

Antibodies, Monoclonal
Osteoarthritis, Knee
Antibodies
Naproxen
Celecoxib
Musculoskeletal Diseases

Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases
Immunoglobulins

ClinicalTrials.gov processed this record on January 14, 2009