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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 ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-003721-22

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

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Extrait

- Characterize the long-term risk of joint safety events in subjects with osteoarthritis of the knee or hip who receive tanezumab 2.5 mg or tanezumab 5 mg SC versus NSAID treatment (naproxen 500 mg BID, celecoxib 100 mg BID, or diclofenac ER 75 mg BID) over the course of 56-weeks of treatment using a composite endpoint (includes adjudication outcomes of rapidly progressive osteoarthritis type-1 or type-2, subchondral insufficiency fracture (SPONK), primary osteonecrosis, or pathological fracture). -Demonstrate superior efficacy of tanezumab 2.5 mg and tanezumab 5 mg SC versus NSAID treatment (naproxen 500 mg BID, celecoxib 100 mg BID, or diclofenac ER 75 mg BID) at Week 16.

Critère d'inclusion

  • Osteoarthritis of the hip or knee

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