TriangleNCT03596645 · OUTCOME
Percentage of Participants With Symptomatic Remission at Week 54
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Week 54
What was measured
Percentage of participants with symptomatic remission at Week 54 was reported. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
Analysis population: Full golimumab analysis set 2 (FGAS2) included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.
Groups in this outcome
Group 1: Golimumab
In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
| Group | Source count |
|---|---|
| Group 1: Golimumab | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1: Golimumab | 39.0 | Not reported | 26.5 | 51.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.5
- upper Limit
- 51.6
- value
- 39.0
- denoms
- counts
- group Id
- OG000
- value
- 41
- units
- Participants
- description
- Percentage of participants with symptomatic remission at Week 54 was reported. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- In short term phase (Week 0-6), participants weighing greater than or equal to (\>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (\<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m\^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m\^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m\^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m\^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor.
- id
- OG000
- title
- Group 1: Golimumab
- param Type
- NUMBER
- population Description
- Full golimumab analysis set 2 (FGAS2) included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only.
- reporting Status
- POSTED
- time Frame
- Week 54
- title
- Percentage of Participants With Symptomatic Remission at Week 54
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice