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Showing 133 results for “Phase 3”.

February 2023

The Effect of Guselkumab on Inhibiting Radiographic Progression in Patients with Active Psoriatic Arthritis: Study Protocol for APEX, a Phase 3b, Multicenter, Randomized, Double‑blind, Placebo‑controlled Trial

Trials. 2023 doi: 10.1186/s13063-022-06945-y

Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.

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January 2023

Bimekizumab In Patients with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumour Necrosis Factor-Α Inhibitors: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial

Lancet. 2023 doi: 10.1016/S0140-6736(22)02303-0

This study showed rapid and clinically meaningful improvements with bimekizumab treatment in patients experiencing active PsA and showing an inadequate response or intolerance to TNFα inhibitors. Its chief aim was to evaluate the efficacy and safety of bimekizumab in patients with an inadequate response or intolerance to TNFα inhibitors.

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Bimekizumab in Patients with Psoriatic Arthritis, Naive To Biologic Treatment: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial (BE OPTIMAL)

Lancet. 2023 doi: 10.1016/S0140-6736(22)02302-9

This study showed that bimekizumab treatment resulted in clinically meaningful and consistent improvements across multiple measures in bDMARD-naïve patients with active PsA. It aimed to assess the efficacy and safety of bimekizumab in patients with active PsA who were naive to bDMARDs.

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November 2022

Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study

Rheumatol Ther. 2022 Oct 15:1–18 doi: 10.1007/s40744-022-00499-w

Results from the long-term extension of SELECT-PsA 1 show efficacy responses similar or greater with upadacitinib, 15 or 30mg, versus adalimumab through 104 weeks.

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September 2022

The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Adv Ther. 2022 Oct;39(10):4632-4644 doi: 10.1007/s12325-022-02269-0

In the latest study by Curtis, et al. guselkumab treatment regimens improved general HRQoL as measured by the EQ-5D-5L Index and EQ-VAS. In reaching this conclusion investigators aimed to determine the minimal important difference for both instruments and to understand the associations between patient-reported EQ-5D-5L Index and EQ-VAS scores as well as key PsA clinical features.

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Olokizumab versus Placebo or Adalimumab in Rheumatoid Arthritis

N Engl J Med. 2022;387(8):715–726. doi: 10.1056/NEJMoa2201302

Phase 3 trial of olokizumab, a direct inhibitor of the IL-6 ligand, demonstrates superiority to placebo with respect to an ACR20 response at week 12 and noninferiority to adalimumab (all combined with methotrexate), in patients with RA.

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August 2022

Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

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Efficacy and Safety of Secukinumab in Patients with Spondyloarthritis and Enthesitis at the Achilles Tendon: Results From a Phase 3b Trial

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keab784

Secukinumab improves the burden of heel enthesitis as assessed by patient and physician reported outcomes in patients with active SpA refractory to standard treatment. In coming to this conclusion, the ACHILLES trial aimed to demonstrate the efficacy of secukinumab on Achilles’ tendon enthesitis in SpA patients.

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