drugset / Trial / NCT02955212

A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)

NCT02955212

Phase 3 Completed 338 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.

Timeline

Start
2018-01-03
Primary completion
2019-08-14
Completion
2020-09-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Upadacitinib Small molecule 15 mg Oral

Indications