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A Study in Moderate to Severe Rheumatoid Arthritis Participants

NCT01721057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 684

Last updated 2019-09-18

Study results available
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Summary

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR \[inadequate response\] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).

Conditions

Interventions

DRUG

Placebo

Administered orally

DRUG

Baricitinib

Administered orally

DRUG

cDMARD

Conventional disease-modifying anti-rheumatic drug as a background therapy

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
2012-12-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Croatia
  • Czechia
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan
  • 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 NCT01721057 on ClinicalTrials.gov