Conditions: Osteoarthritis, Knee / Osteoarthritis, Hip
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief summary:
The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Detailed description:
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.

Arms:
arm 1: MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16. arm 2: MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16. arm 3: MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.

Interventions: intervention 1: MT-5547 intervention 2: MT-5547-matching placebo
Intervention descriptions: intervention 1: Solution for injection in pre-filled syringe intervention 2: Solution for injection in pre-filled syringe

Protocol document:
Prot_000.pdf: 









































































































































































































































SAP_001.pdf: