NCT02186873 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
- id
- FG000
- title
- Group 1: Placebo Then Golimumab
- description
- Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
- id
- FG001
- title
- Group 2: Golimumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 103
- group Id
- FG001
- num Subjects
- 105
- type
- STARTED
- achievements
- comment
- Participants taking placebo crossed over to golimumab
- group Id
- FG000
- num Subjects
- 99
- comment
- Participants continued to receive golimumab
- group Id
- FG001
- num Subjects
- 105
- type
- End of Control Period
- achievements
- group Id
- FG000
- num Subjects
- 94
- group Id
- FG001
- num Subjects
- 97
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram \[mg/kg\] and 103 to placebo group) and treated.
Complete source fields
- groups
- description
- Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
- id
- FG000
- title
- Group 1: Placebo Then Golimumab
- description
- Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
- id
- FG001
- title
- Group 2: Golimumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 103
- group Id
- FG001
- num Subjects
- 105
- type
- STARTED
- achievements
- comment
- Participants taking placebo crossed over to golimumab
- group Id
- FG000
- num Subjects
- 99
- comment
- Participants continued to receive golimumab
- group Id
- FG001
- num Subjects
- 105
- type
- End of Control Period
- achievements
- group Id
- FG000
- num Subjects
- 94
- group Id
- FG001
- num Subjects
- 97
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 9
- group Id
- FG001
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram \[mg/kg\] and 103 to placebo group) and treated.
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