Mprti

First Received: July 19, 2015 | Last Updated: January 10, 2020 Phase: Phase 3 | Start Date: July 21, 2015 Overall Status: Completed | Estimated Enrollment: 3021 Overview The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees. Full Title of Study: “A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE” Study Type • Study Type: Interventional • Study Design • Allocation: Randomized • Intervention Model: Parallel Assignment • Primary Purpose: Treatment • Masking: Double (Participant, Investigator) • Study Primary Completion Date: October 5, 2018 Interventions • Drug: NSAID • Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks • Biological: Tanezumab 2.5 mg • Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks • Biological: Tanezumab 5 mg • Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks Arms, Groups and Cohorts • Active Comparator: NSAID • Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks • Experimental: Tanezumab 2.5 mg • Subcutaneous i...

• Research article • • 29 March 2022 Observed efficacy and clinically important improvements in participants with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study •  ORCID: orcid.org/0000-0002-9515-1711 • • • • • • • • • • • • … • Show authors Arthritis Research & Therapy volume 24, Article number: 78 ( 2022) Background A recent phase 3 study demonstrated that treatment with tanezumab, a nerve growth factor inhibitor, or nonsteroidal anti-inflammatory drugs (NSAIDs) improves pain and physical function in participants with moderate-to-severe osteoarthritis (OA) of the hip or knee. Here, we evaluated the time course and clinical importance of these initial efficacy findings using a mixture of primary, secondary, and post hoc endpoints. Methods Participants on stable NSAID therapy and with a history of inadequate response to other standard OA analgesics were enrolled in an 80-week (56-week treatment/24-week safety follow-up), randomized, NSAID-controlled, phase 3 study primarily designed to assess the safety of tanezumab for moderate-to-severe OA of the knee or hip. Participants received oral NSAID (twice daily naproxen, celecoxib, or diclofenac) or subcutaneous tanezumab (2.5mg or 5mg every 8 weeks). Non-responders were discontinued at week 16. Changes from baseline in WOMAC Pain and Physical Function, Patient’s Global Assessment of Osteoarthritis (PGA-OA), and average pain in the index joint were compared b...

First Received: July 19, 2015 | Last Updated: January 10, 2020 Phase: Phase 3 | Start Date: July 21, 2015 Overall Status: Completed | Estimated Enrollment: 3021 Overview The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees. Full Title of Study: “A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE” Study Type • Study Type: Interventional • Study Design • Allocation: Randomized • Intervention Model: Parallel Assignment • Primary Purpose: Treatment • Masking: Double (Participant, Investigator) • Study Primary Completion Date: October 5, 2018 Interventions • Drug: NSAID • Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks • Biological: Tanezumab 2.5 mg • Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks • Biological: Tanezumab 5 mg • Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks Arms, Groups and Cohorts • Active Comparator: NSAID • Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks • Experimental: Tanezumab 2.5 mg • Subcutaneous i...

• Research article • • 29 March 2022 Observed efficacy and clinically important improvements in participants with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study •  ORCID: orcid.org/0000-0002-9515-1711 • • • • • • • • • • • • … • Show authors Arthritis Research & Therapy volume 24, Article number: 78 ( 2022) Background A recent phase 3 study demonstrated that treatment with tanezumab, a nerve growth factor inhibitor, or nonsteroidal anti-inflammatory drugs (NSAIDs) improves pain and physical function in participants with moderate-to-severe osteoarthritis (OA) of the hip or knee. Here, we evaluated the time course and clinical importance of these initial efficacy findings using a mixture of primary, secondary, and post hoc endpoints. Methods Participants on stable NSAID therapy and with a history of inadequate response to other standard OA analgesics were enrolled in an 80-week (56-week treatment/24-week safety follow-up), randomized, NSAID-controlled, phase 3 study primarily designed to assess the safety of tanezumab for moderate-to-severe OA of the knee or hip. Participants received oral NSAID (twice daily naproxen, celecoxib, or diclofenac) or subcutaneous tanezumab (2.5mg or 5mg every 8 weeks). Non-responders were discontinued at week 16. Changes from baseline in WOMAC Pain and Physical Function, Patient’s Global Assessment of Osteoarthritis (PGA-OA), and average pain in the index joint were compared b...