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

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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

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

Trial documents
2

Trial contacts and locations

409

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Data sourced from clinicaltrials.gov

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