Trial Outcomes & Findings for Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD) (NCT NCT02611817)

Last Updated: 2022-05-25

Results Overview

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (\<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

644 participants

Primary outcome timeframe

Week 52

Results posted on

2022-05-25

Participant Flow

Participants with moderate to severe Crohn's disease (CD) took part in the study at 169 investigative sites in North America, South America, Western/Northern Europe, Central Europe, Eastern Europe, East Asia, and Africa/Australia from 04 Jan 2016 to 06 Aug 2019.

Participants were enrolled in open-label (OL) induction phase to receive vedolizumab (VDZ) intravenous (IV). Participants with clinical response (CR) at Week 6 were randomized into double-blind maintenance phase to receive VDZ subcutaneous/placebo, and who did not achieve CR at Week 6 received 3rd infusion of OL VDZ IV and completed Week 14 visit.

Participant milestones

Participant milestones
Measure	Open-label Induction Phase: Vedolizumab 300 mg IV Vedolizumab 300 milligram (mg), infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase.	Maintenance Phase: Induction IV + Placebo Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Open-label Induction Phase STARTED	644	0	0
Open-label Induction Phase COMPLETED	594	0	0
Open-label Induction Phase NOT COMPLETED	50	0	0
Double-blind Maintenance Phase STARTED	0	135	275
Double-blind Maintenance Phase COMPLETED	0	73	168
Double-blind Maintenance Phase NOT COMPLETED	0	62	107

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Induction Phase: Vedolizumab 300 mg IV Vedolizumab 300 milligram (mg), infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase.	Maintenance Phase: Induction IV + Placebo Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Open-label Induction Phase Reason not Specified	9	0	0
Open-label Induction Phase Lack of Efficacy	8	0	0
Open-label Induction Phase Pregnancy	1	0	0
Open-label Induction Phase Withdrawal by Subject	9	0	0
Open-label Induction Phase Lost to Follow-up	2	0	0
Open-label Induction Phase Protocol Violation	5	0	0
Open-label Induction Phase Adverse Event	16	0	0
Double-blind Maintenance Phase Adverse Event	0	12	11
Double-blind Maintenance Phase Randomized but not Treated	0	1	0
Double-blind Maintenance Phase Reason not Specified	0	1	2
Double-blind Maintenance Phase Lack of Efficacy	0	43	78
Double-blind Maintenance Phase Pregnancy	0	0	1
Double-blind Maintenance Phase Withdrawal by Subject	0	5	14
Double-blind Maintenance Phase Lost to Follow-up	0	0	1

Baseline Characteristics

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction Phase Only: Vedolizumab 300 mg IV n=235 Participants Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6.	Maintenance Phase: Induction IV + Placebo n=134 Participants Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=275 Participants Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.	Total n=644 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 12.79 • n=5 Participants	36.1 years STANDARD_DEVIATION 12.93 • n=7 Participants	38.2 years STANDARD_DEVIATION 13.85 • n=5 Participants	37.5 years STANDARD_DEVIATION 13.29 • n=4 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	68 Participants n=7 Participants	118 Participants n=5 Participants	305 Participants n=4 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	66 Participants n=7 Participants	157 Participants n=5 Participants	339 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants	130 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	185 Participants n=5 Participants	113 Participants n=7 Participants	213 Participants n=5 Participants	511 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) White	207 Participants n=5 Participants	124 Participants n=7 Participants	250 Participants n=5 Participants	581 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Weight	69.94 kilogram (kg) STANDARD_DEVIATION 18.403 • n=5 Participants	69.79 kilogram (kg) STANDARD_DEVIATION 18.103 • n=7 Participants	74.08 kilogram (kg) STANDARD_DEVIATION 18.994 • n=5 Participants	71.68 kilogram (kg) STANDARD_DEVIATION 18.684 • n=4 Participants
Body Mass Index	24.20 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.073 • n=5 Participants	23.93 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.541 • n=7 Participants	25.06 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.915 • n=5 Participants	24.51 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.909 • n=4 Participants
Smoking Classification Never smoked	140 Participants n=5 Participants	85 Participants n=7 Participants	148 Participants n=5 Participants	373 Participants n=4 Participants
Smoking Classification Current smoker	49 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants	129 Participants n=4 Participants
Smoking Classification Ex-smoker	46 Participants n=5 Participants	23 Participants n=7 Participants	73 Participants n=5 Participants	142 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

Population: The full analysis set (FAS): All randomized participants who received at least 1 dose of study SC drug (placebo or VDZ). Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in FAS. Participants in this set were analyzed according to the treatment they were randomized to receive.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=134 Participants Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=275 Participants Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Percentage of Participants Achieving Clinical Remission at Week 52	34.3 percentage of participants Interval 26.3 to 43.0	48.0 percentage of participants Interval 42.0 to 54.1

SECONDARY outcome

Timeframe: Week 52

Population: The FAS included all randomized participants who received at least 1 dose of study SC drug (placebo or VDZ). Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in FAS. Participants in this set were analyzed according to the treatment they were randomized to receive.

Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (\>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=134 Participants Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=275 Participants Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Percentage of Participants Achieving Enhanced Clinical Response at Week 52	44.8 percentage of participants Interval 36.2 to 53.6	52.0 percentage of participants Interval 45.9 to 58.0

SECONDARY outcome

Timeframe: Week 52

Population: Participants from FAS, who used concomitant oral corticosteroid at Baseline. FAS had all participants who received at least 1 dose of SC drug. Participants who only received induction IV therapy and were not randomized into maintenance phase were not included in FAS. Participants were analyzed according to randomized treatment assignment.

Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score \<=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=44 Participants Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=95 Participants Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52	18.2 percentage of participants Interval 8.2 to 32.7	45.3 percentage of participants Interval 35.0 to 55.8

SECONDARY outcome

Timeframe: Week 52

Population: Participants from FAS, who were TNF-alpha antagonist naïve and had clinical remission. FAS had all participants who received at least 1 dose of SC drug. Participants who only received induction IV therapy and were not randomized in maintenance phase were not included in FAS. Participants were analyzed according to randomized treatment assignment.

Clinical remission is defined as CDAI score \<=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Outcome measures

Outcome measures
Measure	Maintenance Phase: Induction IV + Placebo n=63 Participants Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=107 Participants Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52	42.9 percentage of participants Interval 30.5 to 56.0	48.6 percentage of participants Interval 38.8 to 58.5

Adverse Events

Induction Phase Only: Vedolizumab 300 mg IV

Serious events: 39 serious events

Other events: 40 other events

Deaths: 0 deaths

Maintenance Phase: Induction IV + Placebo

Serious events: 14 serious events

Other events: 54 other events

Deaths: 0 deaths

Maintenance Phase: Induction IV + Vedolizumab 108 mg SC

Serious events: 23 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Induction Phase Only: Vedolizumab 300 mg IV n=235 participants at risk Vedolizumab 300 mg, infusion, intravenously, once at Weeks 0, 2 in the open-label induction phase Participants who did not achieve clinical response at Week 6 received third infusion of vedolizumab 300 mg IV on Week 6.	Maintenance Phase: Induction IV + Placebo n=134 participants at risk Vedolizumab placebo-matching injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase.	Maintenance Phase: Induction IV + Vedolizumab 108 mg SC n=275 participants at risk Vedolizumab 108 mg, injection, subcutaneously, once every 2 weeks from Week 6 up to Week 50. Participants who received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab injection subcutaneously in maintenance phase.
Gastrointestinal disorders Crohn's disease	3.0% 7/235 • Number of events 7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	17.2% 23/134 • Number of events 25 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	13.1% 36/275 • Number of events 36 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Gastrointestinal disorders Abdominal pain	3.8% 9/235 • Number of events 11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	8.2% 11/134 • Number of events 14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	7.6% 21/275 • Number of events 25 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Gastrointestinal disorders Nausea	3.8% 9/235 • Number of events 10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	5.2% 7/134 • Number of events 7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	4.0% 11/275 • Number of events 14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Gastrointestinal disorders Vomiting	1.7% 4/235 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	5.2% 7/134 • Number of events 8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	2.2% 6/275 • Number of events 7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Infections and infestations Nasopharyngitis	3.0% 7/235 • Number of events 8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	4.5% 6/134 • Number of events 8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	9.1% 25/275 • Number of events 26 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Infections and infestations Upper respiratory tract infection	0.85% 2/235 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	3.7% 5/134 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	6.2% 17/275 • Number of events 23 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 8/235 • Number of events 8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	6.7% 9/134 • Number of events 10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	6.2% 17/275 • Number of events 21 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.
Nervous system disorders Headache	4.3% 10/235 • Number of events 10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	3.7% 5/134 • Number of events 9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.	5.5% 15/275 • Number of events 19 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to 18 weeks after the last dose of study drug (up to Week 68) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant/observed by the investigator was recorded, irrespective of the relation to study treatment. Participants were regrouped to mirror the baseline groupings for the better readability of the complex design. All participants and events (collected during the study in the induction/maintenance phase) have been accounted for the groupings.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER