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A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

NCT01198002 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1041

Last updated 2018-05-08

Study results available
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Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate.

This study is comprised of 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up

Conditions

Interventions

DRUG

LY2127399

Administered Subcutaneously (SC)

DRUG

Placebo Q2W

Administered SC

DRUG

Placebo Q4W

Administered SC

DRUG

Methotrexate

Methotrexate is 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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2014-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Colombia
  • Croatia
  • Hungary
  • India
  • Japan
  • Lithuania
  • Malaysia
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Sri Lanka
  • Taiwan
  • Ukraine

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 NCT01198002 on ClinicalTrials.gov