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A Study in Moderate to Severe Rheumatoid Arthritis

NCT01710358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1307

Last updated 2019-09-18

Study results available
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Summary

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

Conditions

Interventions

DRUG

Adalimumab

Administered SC

DRUG

Baricitinib

Administered orally

DRUG

Methotrexate

Administered orally

DRUG

Adalimumab Placebo

Adalimumab placebo administered SC.

DRUG

Baricitinib Placebo

Baricitinib placebo administered orally.

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
2012-10-31
Primary Completion
2015-03-31
Completion
2015-09-30

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • China
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • 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 NCT01710358 on ClinicalTrials.gov