NCT01469013 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
- id
- FG000
- title
- Part A: 1 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- FG001
- title
- Part A: 2 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
- id
- FG002
- title
- Part A: 4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- FG003
- title
- Part A: 8 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
- id
- FG004
- title
- Part A: Placebo
- description
- Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG005
- title
- Part:1 mg Baricitinib(LY3009104) / 4 mg Baricitinib(LY3009104)
- description
- Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG006
- title
- Part B: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG007
- title
- Part B: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG008
- title
- Part B: Placebo /4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG009
- title
- Part B: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG010
- title
- Part B: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY300
- description
- Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG011
- title
- Part B: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 24
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 49
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 24
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 49
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 23
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 23
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 48
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Part A (Treatment Period)
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 6
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 12
- group Id
- FG007
- num Subjects
- 23
- group Id
- FG008
- num Subjects
- 24
- group Id
- FG009
- num Subjects
- 11
- group Id
- FG010
- num Subjects
- 12
- group Id
- FG011
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 12
- group Id
- FG007
- num Subjects
- 23
- group Id
- FG008
- num Subjects
- 24
- group Id
- FG009
- num Subjects
- 11
- group Id
- FG010
- num Subjects
- 12
- group Id
- FG011
- num Subjects
- 24
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 10
- group Id
- FG006
- num Subjects
- 7
- group Id
- FG007
- num Subjects
- 18
- group Id
- FG008
- num Subjects
- 20
- group Id
- FG009
- num Subjects
- 8
- group Id
- FG010
- num Subjects
- 10
- group Id
- FG011
- num Subjects
- 18
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 6
- type
- NOT COMPLETED
- title
- Part B (Extension Period)
- pre Assignment Details
- Participants on background methotrexate therapy were assigned to a dose of 1, 2, 4, 8 mg baricitinib (LY3009104) or placebo capsule once daily in a double blind manner for 12 weeks followed by single blind treatment of 4 mg or 8 mg baricitinib (LY3009104) tablet once daily for 52 weeks extension period.
Complete source fields
- groups
- description
- Participants on background methotrexate therapy administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks.
- id
- FG000
- title
- Part A: 1 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- FG001
- title
- Part A: 2 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 1 x 4-mg baricitinib (LY3009104) capsule +1 identical placebo capsule, orally once daily for 12 weeks.
- id
- FG002
- title
- Part A: 4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks.
- id
- FG003
- title
- Part A: 8 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy administered 2 placebo capsules, orally once daily for 12 weeks.
- id
- FG004
- title
- Part A: Placebo
- description
- Participants on background methotrexate therapy who were administered 1 x 1-mg LY3009104 capsule +1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg LY3009104 and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG005
- title
- Part:1 mg Baricitinib(LY3009104) / 4 mg Baricitinib(LY3009104)
- description
- Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG006
- title
- Part B: 2 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 1 x 4-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule, orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG007
- title
- Part B: 4 mg Baricitinib (LY3009104) / 4 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 2 placebo capsules orally once daily for 12 weeks in Part A received 4 mg baricitinib (LY3009104) and 1 placebo tablet orally once daily for 52 weeks in Part B.
- id
- FG008
- title
- Part B: Placebo /4 mg Baricitinib (LY3009104)
- description
- Participants on background methotrexate therapy who were administered 1 x 1-mg baricitinib (LY3009104) capsule + 1 identical placebo capsule orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG009
- title
- Part B: 1 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
- description
- Participants on background methotrexate therapy who were administered 2 x 1-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG010
- title
- Part B: 2 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY300
- description
- Participants on background methotrexate therapy who were administered 2 x 4-mg baricitinib (LY3009104) capsules orally once daily for 12 weeks in Part A received 2 x 4 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
- id
- FG011
- title
- Part B: 8 mg Baricitinib (LY3009104) / 8 mg Baricitinib (LY30
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 24
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 49
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 24
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 24
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 49
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 23
- group Id
- FG001
- num Subjects
- 24
- group Id
- FG002
- num Subjects
- 23
- group Id
- FG003
- num Subjects
- 24
- group Id
- FG004
- num Subjects
- 48
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Part A (Treatment Period)
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 6
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 12
- group Id
- FG007
- num Subjects
- 23
- group Id
- FG008
- num Subjects
- 24
- group Id
- FG009
- num Subjects
- 11
- group Id
- FG010
- num Subjects
- 12
- group Id
- FG011
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 12
- group Id
- FG006
- num Subjects
- 12
- group Id
- FG007
- num Subjects
- 23
- group Id
- FG008
- num Subjects
- 24
- group Id
- FG009
- num Subjects
- 11
- group Id
- FG010
- num Subjects
- 12
- group Id
- FG011
- num Subjects
- 24
- type
- Received at Least 1 Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 10
- group Id
- FG006
- num Subjects
- 7
- group Id
- FG007
- num Subjects
- 18
- group Id
- FG008
- num Subjects
- 20
- group Id
- FG009
- num Subjects
- 8
- group Id
- FG010
- num Subjects
- 10
- group Id
- FG011
- num Subjects
- 18
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 5
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 6
- type
- NOT COMPLETED
- title
- Part B (Extension Period)
- pre Assignment Details
- Participants on background methotrexate therapy were assigned to a dose of 1, 2, 4, 8 mg baricitinib (LY3009104) or placebo capsule once daily in a double blind manner for 12 weeks followed by single blind treatment of 4 mg or 8 mg baricitinib (LY3009104) tablet once daily for 52 weeks extension period.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle