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

COMPLETEDPHASE3

A Rheumatoid Arthritis Study in Participants

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)

NCT01202760•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 with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. This study is comprised of 2 periods: Period 1 - 24-week blinded treatment Period 2 - 48-week post-treatment follow-up

Detailed Description

In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with \<20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
•Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
•If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
•Women must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria

•Use of unstable doses of non-steroidal 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 per day (mg/day) of oral steroids in the last 6 weeks
•Use of biologic DMARD concurrently or recently
•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 prior to study start, 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 within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
+6 more criteria

Locations (213)

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

Paradise Valley, Arizona, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

San Diego, California, United States

Torrance, California, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

December 1, 2012

Completion Date

July 1, 2013

Last Updated

April 25, 2018

Enrollment

1,004

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

LY2127399

DRUG

Placebo

DRUG

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

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

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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: April 25, 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 Rheumatoid Arthritis Study in Participants

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

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

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis