An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

Lilly

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01885078

14060

2012-003686-17 (EudraCT Number)

I4V-MC-JADY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,877 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,877 participants in 4 patient groups

4 milligram (mg) Baricitinib

Experimental group

Description:

4 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Treatment:

Drug: Placebo

Drug: Baricitinib

2 mg Baricitinib

Experimental group

Description:

2 mg Baricitinib administered orally once daily. Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Treatment:

Drug: Placebo

Drug: Baricitinib

2 mg Baricitinib Step-down

Experimental group

Description:

2 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Treatment:

Drug: Baricitinib

4 mg Baricitinib Step-down

Experimental group

Description:

4 mg Baricitinib administered orally once daily in the 96-week Step-down period. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

Treatment:

Drug: Baricitinib