drugset / Trial / NCT03104400

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Phase 3 Completed 1705 enrolled AbbVie

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Timeline

Start: 2017-04-27
Primary completion: 2019-09-26
Completion: 2024-09-09

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Upadacitinib 15 mg; p <0.0001; Response Rate Difference 34.5 (95% CI 28.2 to 40.7); Cochran-Mantel-Haenszel NCT03104400 ↗

registry analysis (superiority test); Placebo vs Upadacitinib 30 mg; p <0.0001; Response Rate Difference 42.3 (95% CI 36.3 to 48.3); Cochran-Mantel-Haenszel NCT03104400 ↗

release “In both Phase 3 clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo” abbvie.com ↗

release “Across SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials, RINVOQ met its primary endpoint of ACR20 at week 12” abbvie.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Upadacitinib	Small molecule	15 mg	Oral
Subject	Upadacitinib	Small molecule	30 mg	Oral