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A Study in Participants With Moderate to Severe Rheumatoid Arthritis

NCT01711359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2019-09-19

Study results available
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Summary

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

Conditions

Interventions

DRUG

Baricitinib

Administered orally

DRUG

Methotrexate

Administered orally

DRUG

Baricitinib Placebo

Baricitinib placebo administered orally once daily.

DRUG

MTX Placebo

MTX placebo administered orally once weekly.

DRUG

Folic Acid

Administered orally every day

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
2012-11-30
Primary Completion
2015-02-28
Completion
2015-08-31

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Germany
  • Greece
  • India
  • Italy
  • Japan
  • Mexico
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Sweden
  • 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 NCT01711359 on ClinicalTrials.gov