MedTrace Logo

A Moderate to Severe Rheumatoid Arthritis Study

NCT01721044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2019-09-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

Conditions

Interventions

DRUG

Placebo

Administered orally

DRUG

Baricitinib

Administered orally

DRUG

cDMARD

Participants will continue to take background cDMARD therapy throughout study.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01721044 on ClinicalTrials.gov