CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,002 enrolled
Drug / intervention
Placebo to Upadacitinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02706873
NCT02706873Phase 3Completed
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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis

AbbVie·interventional·Posted Mar 11, 2016·Updated Jul 7, 2023

In Brief

A Phase 3 clinical trial evaluating Placebo to Upadacitinib, Methotrexate, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 1,002 participants across 290 sites in 45 countries.

Detailed Summary

The objectives of Period 1 were the following: * To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; * To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 11, 2016
Enrollment StartFeb 23, 2016
Primary CompletionMar 15, 2018
Study CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.3 years ago

Interventions

Placebo to Upadacitinibdrug

Tablet; Oral

Methotrexatedrug

Capsule or Tablet; Oral

Placebo to Methotrexatedrug

Capsule or Tablet; Oral

Upadacitinibdrug

Tablet; Oral