Tanezumab in Osteoarthritis of the Knee

• ClinicalTrials.gov Identifier: NCT00733902
• Recruitment Status: Completed
• First Posted: August 13, 2008
• Last Update Posted: January 7, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 11, 2008
• First Posted Date: August 13, 2008
• Last Update Posted Date: January 7, 2011
• Study Start Date: September 2008
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2008)

• WOMAC function [ Time Frame: Week 16 ]
• WOMAC pain [ Time Frame: Week 16 ]
• Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ]

Original Primary Outcome Measures (submitted: August 12, 2008)

• Patient Global Assessment of Osteoarthritis [ Time Frame: Week 24 ]
• WOMAC function [ Time Frame: Week 24 ]
• WOMAC pain [ Time Frame: Week 24 ]

Current Secondary Outcome Measures (submitted: December 4, 2008)

• Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]
• SF-36 [ Time Frame: Weeks 12 and 24 ]
• Daily NRS scores [ Time Frame: daily to Week 32 ]
• Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
• Time to discontinuation [ Time Frame: All weeks ]

Original Secondary Outcome Measures (submitted: August 12, 2008)

• SF-36 [ Time Frame: Weeks 12 and 24 ]
• Daily NRS scores [ Time Frame: daily to Week 32 ]
• Safety (laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
• Time to discontinuation [ Time Frame: All weeks ]
• Womac pain, physical function and stiffnes at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tanezumab in Osteoarthritis of the Knee
• Official Title: A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee
• Brief Summary: Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Arthritis
• Osteoarthritis

Intervention

• Biological: tanezumab
  IV tanezumab 10 mg at 1 dose every 8 weeks
• Biological: tanezumab
  IV tanezumab 5 mg at 1 dose every 8 weeks
• Biological: tanezumab
  IV tanezumab 2.5 mg at 1 dose every 8 weeks
• Biological: Placebo
  IV placebo to match tanezumab at 1 dose every 8 weeks

Study Arms

• Experimental: Tanezumab 10 mg
  Intervention: Biological: tanezumab
• Experimental: Tanezumab 5 mg
  Intervention: Biological: tanezumab
• Experimental: Tanezumab 2.5 mg
  Intervention: Biological: tanezumab
• Placebo Comparator: Placebo
  Intervention: Biological: Placebo

Publications *

• Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum in: J Pain Res. 2020 Sep 14;13:2267-2268.
• Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 12, 2009): 697
• Original Estimated Enrollment (submitted: August 12, 2008): 600
• Actual Study Completion Date: November 2009
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
• Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
• Pain level and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
• Must agree to the contraceptive requirements of the protocol if applicable.
• Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

Exclusion Criteria:

• Pregnancy or intent to become pregnant during the study
• BMI greater than 39
• other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00733902
• Other Study ID Numbers: A4091011
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2011