Participant flow

A Moderate to Severe Rheumatoid Arthritis Study · Source last updated 2019-09-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

   id

   FG000

   title

   Placebo

2. description

   Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

   id

   FG001

   title

   Baricitinib 2 mg

3. description

   Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

   id

   FG002

   title

   Baricitinib 4 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         10

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         176

      2. comment

         Randomized to 4mg (N=11) but received 2mg due to moderate renal impairment were included in 4mg arm

         group Id

         FG001

         num Subjects

         174

      3. group Id

         FG002

         num Subjects

         177

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         56

      2. group Id

         FG001

         num Subjects

         38

      3. group Id

         FG002

         num Subjects

         33

      type

      Rescue Week 16-24

   3. achievements

      1. group Id

         FG000

         num Subjects

         144

      2. group Id

         FG001

         num Subjects

         157

      3. group Id

         FG002

         num Subjects

         158

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         19

      type

      NOT COMPLETED

   title

   Treatment Period

2. milestones

   1. achievements

      1. comment

         Participants from treatment who entered the post-treatment follow-up period.

         group Id

         FG000

         num Subjects

         19

      2. comment

         Participants from treatment who entered the post-treatment follow-up period.

         group Id

         FG001

         num Subjects

         9

      3. comment

         Participants from treatment and rescue who entered the post-treatment follow-up period.

         group Id

         FG002

         num Subjects

         20

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         20

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Follow Up

pre Assignment Details

Participants who did not adequately respond (nonresponders) to study drug were eligible for rescue treatment with baricitinib 4 mg beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice