MedTrace Logo

A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

NCT02066389 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-07-30

Study results available
· View outcomes & findings →

Summary

The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.

Conditions

Interventions

DRUG

Placebo

Tablets for oral administration

DRUG

Upadacitinib

Tablets for oral administration

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-26
Primary Completion
2015-07-02
Completion
2015-07-02
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Chile
  • Czechia
  • Hungary
  • Israel
  • Latvia
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066389 on ClinicalTrials.gov