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A Study in Participants With Rheumatoid Arthritis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study in Participants With Rheumatoid Arthritis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

NCT01202773•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of RA of more than 6 months and less than 15 years
•At least 8 tender and swollen joints
•An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
•Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
•Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
•Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
•Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria

•Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
•Steroid injection or intravenous (IV) infusion in the last 6 weeks
•Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
•History of a serious reaction to other biological DMARDs
•Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
•Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
•Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
•Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
•Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
•Hepatitis or human immunodeficiency virus (HIV)
+5 more criteria

Locations (201)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Paradise Valley, Arizona, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Escondido, California, United States

Fresno, California, United States

Hemet, California, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

March 1, 2013

Completion Date

January 1, 2014

Last Updated

May 14, 2018

Enrollment

456

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

LY2127399

DRUG

Placebo Q4W

DRUG

Placebo Q2W

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study in Participants With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis