An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.

Key facts

Study ID

NCT01885078

Run by

Eli Lilly and Company

People needed

2877

Starts

2013-06-27

Expected to finish

2020-11-12

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)

You may not qualify if…

• Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
• Have a known hypersensitivity to baricitinib or any component of this investigational product
• Had investigational product permanently discontinued at any time during a previous baricitinib study
• Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
• Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol

Where it is running

• Arizona Arthritis & Rheumatology Associates, P. C. — Mesa, Arizona, United States
• Sun Valley Arthritis Center, LTD — Peoria, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Valley Endocrine, Fresno — Fresno, California, United States
• Allergy and Rheumatology Medical Clinic Inc — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Stanford University Hospital — Palo Alto, California, United States
• Pacific Arthritis Center — Santa Maria, California, United States
• Inland Rheumatology & Osteoporosis Medical Group — Upland, California, United States
• Boulder Medical Center — Boulder, Colorado, United States
• Denver Arthritis Clinic - Lowry — Denver, Colorado, United States
• New England Research Associates — Bridgeport, Connecticut, United States
• Clinical Research Center of CT/NY — Danbury, Connecticut, United States
• Delaware Arthritis — Lewes, Delaware, United States
• Orthopedic Research Institute — Boynton Beach, Florida, United States
• Medallion Clinical Research Institute — Naples, Florida, United States
• Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Rheumatology Associates of Central Florida — Orlando, Florida, United States
• Arthritis Research of Florida — Palm Harbor, Florida, United States
• West Broward Rheumatology Associates, Inc — Tamarac, Florida, United States
• AdventHealth Medical Group — Tampa, Florida, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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