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A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

NCT02706873 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2023-07-07

Study results available
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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.

Conditions

Interventions

DRUG

Placebo to Upadacitinib

Tablet; Oral

DRUG

Methotrexate

Capsule or Tablet; Oral

DRUG

Placebo to Methotrexate

Capsule or Tablet; Oral

DRUG

Upadacitinib

Tablet; Oral

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-23
Primary Completion
2018-03-15
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

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 NCT02706873 on ClinicalTrials.gov