7-Study Placebo-Controlled Dataset
Studies: JADC, JADA, JADN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE
Compares BARI 4 mg vs placebo
Includes patients with RA from 3 phase 2 and 4 phase 3 studies who were randomized to
- BARI 4 mg (N=1142, [exposure through 24 weeks: PYE=471.8, median exposure=169 days, maximum exposure=211 days]), or
- placebo (N=1215, [exposure through 24 weeks: PYE=450.8, median exposure=166 days, maximum exposure=235 days]).
Patients in the placebo group could have been taking
- background MTX, or
- in some studies, other conventional DMARD therapy.
Evaluation time periods included
- through the 12-week placebo-controlled period in phase 2 studies
- through 16 weeks of assigned treatment before any opportunity for rescue therapy in phase 3 studies, and
- through 24 weeks of assigned treatment or until rescue in phase 3 studies.
BARI 2 mg Analysis Set
BARI 2 mg data is derived from 4 studies in which both BARI 2 mg (N=479, [exposure through 24 weeks: PYE=185.8, median exposure=168 days, maximum exposure=197 days]) and BARI 4 mg were options during randomization (JADA, JADN, RA-BUILD, RA-BEACON).
4-Study Extended Dataset
Studies: JADA, JADN, RA-BUILD, RA-BEACON, RA-BEYOND (extension)
Compares BARI 4 mg vs BARI 2 mg including extended evaluations
Includes patients with RA from 2 phase 2 and 2 phase 3 studies and any further exposure for those patients in the phase 3 extension study, RA-BEYOND, who were randomized to
- BARI 4 mg (N=479, PYE=781.1, median exposure=342 days, maximum exposure=3085 days), or
- BARI 2 mg (N=479, PYE=774.9, median exposure=257 days, maximum exposure=2370 days).
Evaluation time period included randomization through last available observation incorporating extension data through 01 September 2019 unless otherwise specified.
All BARI RA Dataset
Studies: JADB, JADC, JADA, JADN, RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BALANCE, RA-BEYOND (extension)
No between-group comparisons
Includes patients with RA (N=3770, PYE=13,148, median exposure=4.2 yrs, maximum exposure=8.4 yrs) from 1 phase 1, 3 phase 2, 5 phase 3 studies, and 1 phase 3 extension study who received BARI at a variety of doses, including
- BARI 4 mg (n=3400)
- BARI 2 mg (n=1077), and
- BARI 1 mg, 7 mg, 8 mg, and 10 mg QD doses not evaluated in confirmatory studies.
Patients had to have received at least 1 dose of BARI and could have received different doses throughout the trials.
Evaluation time period is all exposure time points including after rescue or changes in study drug through 01 September 2019 unless otherwise specified.