Trial Outcomes & Findings for Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically (NCT NCT02808975)
NCT ID: NCT02808975
Last Updated: 2020-05-14
Results Overview
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
206 participants
Primary outcome timeframe
At Week 12
Results posted on
2020-05-14
Participant Flow
Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit
Participant milestones
| Measure |
Placebo
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
103
|
|
Overall Study
COMPLETED
|
81
|
84
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
|
Overall Study
Withdrew consent
|
9
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Planned HS surgery performed prior Wk 13
|
1
|
0
|
|
Overall Study
Other, not specified
|
5
|
1
|
Baseline Characteristics
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Baseline characteristics by cohort
| Measure |
Placebo
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 10.81 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 11.71 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
97 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12Population: Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data
HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Outcome measures
| Measure |
Placebo
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
|
34.0 percentage of participants
Interval 24.8 to 43.1
|
47.6 percentage of participants
Interval 37.9 to 57.2
|
SECONDARY outcome
Timeframe: At Week12Population: Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Outcome measures
| Measure |
Placebo
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Percentage of Participants Achieving HiSCR-es at Week 12
|
35.0 percentage of participants
Interval 25.7 to 44.2
|
47.6 percentage of participants
Interval 37.9 to 57.2
|
SECONDARY outcome
Timeframe: At Week 24Population: Intent-to-Treat (ITT) population: all participants who were randomized at the Baseline visit; non-responder imputation (NRI) was used for missing data
Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.
Outcome measures
| Measure |
Placebo
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Percentage of Participants Achieving HiSCR-es at Week 24
|
31.1 percentage of participants
Interval 22.1 to 40.0
|
51.5 percentage of participants
Interval 41.8 to 61.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit.
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented.
Outcome measures
| Measure |
Placebo
n=79 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=76 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12
|
26.233 percent change from Baseline
Interval -31.684 to 84.15
|
68.190 percent change from Baseline
Interval 8.485 to 127.896
|
SECONDARY outcome
Timeframe: At Week 12Population: Observed case (OC) analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomized at the Baseline visit.
The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.
Outcome measures
| Measure |
Placebo
n=87 Participants
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=82 Participants
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
|
43.7 percentage of participants
Interval 33.3 to 54.1
|
46.3 percentage of participants
Interval 35.5 to 57.1
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Adalimumab
Serious events: 7 serious events
Other events: 48 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=103 participants at risk
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 participants at risk
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
BLASTOCYSTIS INFECTION
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TESTIS CANCER
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
RUPTURED CEREBRAL ANEURYSM
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
1.9%
2/103 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/103 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Placebo
n=103 participants at risk
Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week
Period B: Weeks 13-14- 1 SC injection each week
Period C: Weeks 15-23- 1 SC injection each week
|
Adalimumab
n=103 participants at risk
Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week
Period B: Weeks 13-14- 1 SC 40 mg injection each week
Period C: Weeks 15-23- 1 SC 40 mg injection each week
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
3.9%
4/103 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.8%
6/103 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.4%
19/103 • Number of events 24 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
18.4%
19/103 • Number of events 23 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
7.8%
8/103 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
13.6%
14/103 • Number of events 14 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.97%
1/103 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.8%
6/103 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DIZZINESS
|
5.8%
6/103 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
2/103 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
13.6%
14/103 • Number of events 29 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
12.6%
13/103 • Number of events 13 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
14.6%
15/103 • Number of events 19 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
13.6%
14/103 • Number of events 17 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug, up to 33 weeks.
TEAEs and SAEs are defined as any adverse event (AE) with an onset date that is on or after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER