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Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER (OLE))

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ClinicalTrials.gov Identifier: NCT01635764
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : September 5, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Intervention Biological: adalimumab
Enrollment 508
Recruitment Details  
Pre-assignment Details Subjects were evaluated for entry into Study M12-555 at the final study visit of the prior phase 3 study in which they participated. Therefore, the Study M12-555 Week 0 visit and administration of the first dose of study drug in Study M12-555 was performed on the same day as the final or last visit of the prior Phase 3 study.
Arm/Group Title Adalimumab Every Week
Hide Arm/Group Description Adalimumab 40 mg every week.
Period Title: Overall Study
Started 508
Completed 235
Not Completed 273
Reason Not Completed
Adverse Event             46
Lack of Efficacy             76
Exceed Protocol-specified Interventions             2
Protocol Deviation             1
Withdrew Consent             67
Lost to Follow-up             53
Not Specified             28
Arm/Group Title EW/EW/EW EW/EOW/EW EW/PBO/EW PBO/EW/EW PBO/PBO/EW Total
Hide Arm/Group Description All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies. All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies. All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies. All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313. All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810. Total of all reporting groups
Overall Number of Baseline Participants 88 90 92 115 123 508
Hide Baseline Analysis Population Description
Baseline characteristics provided by reporting groups defined by treatment received in the prior phase 3 studies, plus adalimumab every week (EW) received in M12-555. Baseline defined as the last measurement prior to the first dose of study drug in the prior phase 3 study (M11-810 or M11-310 for baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 90 participants 92 participants 115 participants 123 participants 508 participants
35.5  (10.27) 36.1  (10.50) 36.5  (11.06) 38.5  (11.92) 37.0  (12.28) 36.8  (11.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 90 participants 92 participants 115 participants 123 participants 508 participants
Female
56
  63.6%
60
  66.7%
50
  54.3%
79
  68.7%
83
  67.5%
328
  64.6%
Male
32
  36.4%
30
  33.3%
42
  45.7%
36
  31.3%
40
  32.5%
180
  35.4%
1.Primary Outcome
Title Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Hide Description Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title EW/EW/EW EW/EOW/EW EW/PBO/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
Overall Number of Participants Analyzed 88 90 92
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 Number Analyzed 88 participants 88 participants 91 participants
34.1 39.8 34.1
Week 4 Number Analyzed 88 participants 90 participants 92 participants
38.6 41.1 40.2
Week 8 Number Analyzed 88 participants 90 participants 92 participants
51.1 48.9 47.8
Week 12 Number Analyzed 88 participants 90 participants 92 participants
52.3 55.6 51.1
Week 16 Number Analyzed 88 participants 90 participants 92 participants
50.0 56.7 45.7
Week 20 Number Analyzed 88 participants 90 participants 92 participants
56.8 45.6 45.7
Week 24 Number Analyzed 88 participants 90 participants 92 participants
48.9 47.8 42.4
Week 36 Number Analyzed 88 participants 90 participants 92 participants
62.5 54.4 52.2
Week 48 Number Analyzed 88 participants 90 participants 92 participants
58.0 55.6 58.7
Week 60 Number Analyzed 88 participants 90 participants 92 participants
62.5 57.8 58.7
Week 72 Number Analyzed 88 participants 90 participants 92 participants
59.1 61.1 53.3
Week 84 Number Analyzed 88 participants 90 participants 92 participants
56.8 56.7 55.4
Week 96 Number Analyzed 88 participants 90 participants 92 participants
56.8 54.4 53.3
Week 108 Number Analyzed 88 participants 90 participants 92 participants
60.2 56.7 53.3
Week 120 Number Analyzed 88 participants 90 participants 92 participants
56.8 52.2 45.7
Week 132 Number Analyzed 88 participants 90 participants 92 participants
52.3 52.2 50.0
Week 144 Number Analyzed 88 participants 90 participants 92 participants
51.1 54.4 52.2
Week 156 Number Analyzed 88 participants 90 participants 92 participants
48.9 52.2 50.0
Week 168 Number Analyzed 88 participants 90 participants 92 participants
52.3 53.3 46.7
Week 180 Number Analyzed 88 participants 90 participants 92 participants
51.1 54.4 46.7
Week 192 Number Analyzed 88 participants 90 participants 92 participants
51.1 55.6 46.7
Week 204 Number Analyzed 88 participants 90 participants 92 participants
50.0 54.4 46.7
Week 216 Number Analyzed 88 participants 90 participants 92 participants
50.0 54.4 46.7
2.Primary Outcome
Title Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Hide Description Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title PBO/EW/EW
Hide Arm/Group Description:
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
Overall Number of Participants Analyzed 115
Measure Type: Number
Unit of Measure: percentage of participants
Entry of Period B Number Analyzed 115 participants
26.1
Week 12 Number Analyzed 114 participants
54.4
Week 24 Number Analyzed 114 participants
57.9
Week 36 Number Analyzed 114 participants
57.0
Week 48 Number Analyzed 114 participants
60.5
Week 60 Number Analyzed 114 participants
57.0
Week 72 Number Analyzed 114 participants
50.0
Week 84 Number Analyzed 114 participants
50.0
Week 96 Number Analyzed 114 participants
53.5
Week 108 Number Analyzed 114 participants
52.6
Week 120 Number Analyzed 114 participants
53.5
Week 132 Number Analyzed 114 participants
56.1
Week 144 Number Analyzed 114 participants
51.8
Week 156 Number Analyzed 114 participants
52.6
Week 168 Number Analyzed 114 participants
55.3
Week 180 Number Analyzed 114 participants
54.4
Week 192 Number Analyzed 114 participants
53.5
Week 204 Number Analyzed 114 participants
53.5
3.Primary Outcome
Title Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit
Hide Description Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title PBO/PBO/EW
Hide Arm/Group Description:
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
Overall Number of Participants Analyzed 123
Measure Type: Number
Unit of Measure: percentage of participants
Entry of M12-555 Number Analyzed 123 participants
19.5
Week 4 Number Analyzed 122 participants
46.7
Week 8 Number Analyzed 122 participants
51.6
Week 12 Number Analyzed 122 participants
48.4
Week 18 Number Analyzed 122 participants
57.4
Week 24 Number Analyzed 122 participants
55.7
Week 36 Number Analyzed 122 participants
60.7
Week 48 Number Analyzed 122 participants
54.9
Week 60 Number Analyzed 122 participants
55.7
Week 72 Number Analyzed 122 participants
54.9
Week 84 Number Analyzed 122 participants
54.9
Week 96 Number Analyzed 122 participants
57.4
Week 108 Number Analyzed 122 participants
54.9
Week 120 Number Analyzed 122 participants
52.5
Week 132 Number Analyzed 122 participants
54.1
Week 144 Number Analyzed 122 participants
51.6
Week 156 Number Analyzed 122 participants
50.8
Week 168 Number Analyzed 122 participants
51.6
Week 180 Number Analyzed 122 participants
51.6
Week 192 Number Analyzed 122 participants
51.6
4.Primary Outcome
Title Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit
Hide Description The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title EW/EW/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 22.7
Week 4 28.4
Week 8 38.6
Week 12 35.2
Week 16 37.5
Week 20 42.0
Week 24 36.4
Week 36 48.9
Week 48 46.6
Week 60 43.2
Week 72 50.0
Week 84 45.5
Week 96 44.3
Week 108 46.6
Week 120 44.3
Week 132 44.3
Week 144 43.2
Week 156 45.5
Week 168 46.6
Week 180 46.6
Week 192 47.7
Week 204 47.7
Week 216 46.6
5.Primary Outcome
Title Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit
Hide Description The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title EW/EOW/EW EW/PBO/EW PBO/PBO/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
Overall Number of Participants Analyzed 90 92 123
Measure Type: Number
Unit of Measure: percentage of participants
Entry of M12-555 Number Analyzed 90 participants 92 participants 123 participants
31.1 22.8 21.1
Week 4 Number Analyzed 87 participants 92 participants 122 participants
35.6 34.8 44.3
Week 8 Number Analyzed 88 participants 92 participants 122 participants
43.2 42.4 53.3
Week 12 Number Analyzed 88 participants 92 participants 122 participants
45.5 44.6 45.1
Week 18 Number Analyzed 88 participants 92 participants 122 participants
50.0 41.3 50.0
Week 24 Number Analyzed 88 participants 92 participants 122 participants
43.2 46.7 57.4
Week 36 Number Analyzed 88 participants 92 participants 122 participants
54.5 45.7 57.4
Week 48 Number Analyzed 88 participants 92 participants 122 participants
50.0 42.4 52.5
Week 60 Number Analyzed 88 participants 92 participants 122 participants
48.9 43.5 51.6
Week 72 Number Analyzed 88 participants 92 participants 122 participants
50.0 43.5 54.1
Week 84 Number Analyzed 88 participants 92 participants 122 participants
53.4 44.6 50.8
Week 96 Number Analyzed 88 participants 92 participants 122 participants
51.1 40.2 52.5
Week 108 Number Analyzed 88 participants 92 participants 122 participants
51.1 40.2 51.6
Week 120 Number Analyzed 88 participants 92 participants 122 participants
46.6 37.0 52.5
Week 132 Number Analyzed 88 participants 92 participants 122 participants
51.1 37.0 53.3
Week 144 Number Analyzed 88 participants 92 participants 122 participants
48.9 41.3 52.5
Week 156 Number Analyzed 88 participants 92 participants 122 participants
47.7 39.1 51.6
Week 168 Number Analyzed 88 participants 92 participants 122 participants
51.1 35.9 51.6
Week 180 Number Analyzed 88 participants 92 participants 122 participants
51.1 35.9 51.6
Week 192 Number Analyzed 88 participants 92 participants 122 participants
51.1 35.9 51.6
6.Primary Outcome
Title Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit
Hide Description The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title PBO/EW/EW
Hide Arm/Group Description:
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
Overall Number of Participants Analyzed 115
Measure Type: Number
Unit of Measure: percentage of participants
Entry of Period B Number Analyzed 115 participants
20.0
Week 12 Number Analyzed 114 participants
38.6
Week 24 Number Analyzed 114 participants
43.0
Week 36 Number Analyzed 114 participants
42.1
Week 48 Number Analyzed 114 participants
43.9
Week 60 Number Analyzed 114 participants
45.6
Week 72 Number Analyzed 114 participants
43.9
Week 84 Number Analyzed 114 participants
43.9
Week 96 Number Analyzed 114 participants
46.5
Week 108 Number Analyzed 114 participants
42.1
Week 120 Number Analyzed 114 participants
45.6
Week 132 Number Analyzed 114 participants
46.5
Week 144 Number Analyzed 114 participants
49.1
Week 156 Number Analyzed 114 participants
45.6
Week 168 Number Analyzed 114 participants
46.5
Week 180 Number Analyzed 114 participants
45.6
Week 192 Number Analyzed 114 participants
45.6
Week 204 Number Analyzed 114 participants
45.6
7.Primary Outcome
Title Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population
Hide Description The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title EW/EW/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -18.0  (25.27)
Week 4 -21.0  (31.81)
Week 8 -22.8  (35.45)
Week 12 -23.9  (48.30)
Week 16 -26.6  (54.63)
Week 20 -32.1  (73.69)
Week 24 -36.6  (74.99)
Week 36 -41.6  (93.11)
Week 48 -42.2  (115.22)
Week 60 -41.9  (119.98)
Week 72 -43.2  (122.30)
Week 84 -42.8  (123.18)
Week 96 -43.2  (126.21)
Week 108 -43.2  (124.92)
Week 120 -43.4  (127.65)
Week 132 -42.5  (128.45)
Week 144 -42.4  (129.37)
Week 156 -40.7  (130.30)
Week 168 -41.5  (130.40)
Week 180 -41.8  (129.89)
Week 192 -41.9  (130.46)
Week 204 -41.4  (130.72)
Week 216 -41.4  (130.94)
8.Primary Outcome
Title Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations
Hide Description The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title EW/EOW/EW EW/PBO/EW PBO/PBO/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
Overall Number of Participants Analyzed 90 92 123
Mean (Standard Deviation)
Unit of Measure: units on a scale
Entry of M12-555 Number Analyzed 90 participants 92 participants 123 participants
-23.1  (56.94) -10.5  (56.74) 0.2  (51.35)
Week 4 Number Analyzed 87 participants 92 participants 122 participants
-30.2  (48.99) -18.8  (56.52) -16.2  (56.16)
Week 8 Number Analyzed 88 participants 92 participants 122 participants
-34.9  (47.42) -21.2  (63.26) -24.8  (51.55)
Week 12 Number Analyzed 88 participants 92 participants 122 participants
-34.8  (55.71) -25.5  (57.92) -26.2  (54.58)
Week 18 Number Analyzed 88 participants 92 participants 122 participants
-35.9  (47.92) -26.2  (60.59) -32.3  (48.60)
Week 24 Number Analyzed 88 participants 92 participants 122 participants
-37.1  (47.39) -24.1  (61.52) -33.5  (50.20)
Week 36 Number Analyzed 88 participants 92 participants 122 participants
-37.1  (46.07) -24.7  (63.81) -33.6  (57.58)
Week 48 Number Analyzed 88 participants 92 participants 122 participants
-37.5  (47.94) -24.8  (63.21) -30.2  (64.84)
Week 60 Number Analyzed 88 participants 92 participants 122 participants
-34.8  (50.17) -22.6  (65.06) -31.7  (66.33)
Week 72 Number Analyzed 88 participants 92 participants 122 participants
-35.4  (55.22) -20.1  (64.52) -31.8  (65.26)
Week 84 Number Analyzed 88 participants 92 participants 122 participants
-36.6  (51.33) -20.0  (66.02) -29.5  (65.79)
Week 96 Number Analyzed 88 participants 92 participants 122 participants
-34.0  (49.42) -18.3  (65.14) -29.0  (68.85)
Week 108 Number Analyzed 88 participants 92 participants 122 participants
-34.0  (54.41) -18.3  (66.88) -28.4  (71.52)
Week 120 Number Analyzed 88 participants 92 participants 122 participants
-31.8  (60.85) -16.2  (66.82) -28.3  (70.37)
Week 132 Number Analyzed 88 participants 92 participants 122 participants
-35.1  (53.01) -16.7  (66.87) -28.8  (69.79)
Week 144 Number Analyzed 88 participants 92 participants 122 participants
-35.1  (53.94) -16.6  (67.30) -28.6  (70.03)
Week 156 Number Analyzed 88 participants 92 participants 122 participants
-34.7  (53.95) -15.7  (67.09) -28.0  (69.11)
Week 168 Number Analyzed 88 participants 92 participants 122 participants
-35.6  (53.72) -15.5  (67.40) -28.7  (69.81)
Week 180 Number Analyzed 88 participants 92 participants 122 participants
-35.6  (53.64) -15.4  (67.39) -28.7  (69.81)
Week 192 Number Analyzed 88 participants 92 participants 122 participants
-35.6  (53.64) -15.4  (67.39) -28.7  (69.81)
9.Primary Outcome
Title Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population
Hide Description The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data at given time point.
Arm/Group Title PBO/EW/EW
Hide Arm/Group Description:
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
Entry of Period B Number Analyzed 115 participants
-18.0  (38.32)
Week 12 Number Analyzed 114 participants
-43.2  (48.07)
Week 24 Number Analyzed 114 participants
-43.0  (53.08)
Week 36 Number Analyzed 114 participants
-49.5  (57.05)
Week 48 Number Analyzed 114 participants
-47.1  (61.95)
Week 60 Number Analyzed 114 participants
-46.2  (60.94)
Week 72 Number Analyzed 114 participants
-44.5  (67.13)
Week 84 Number Analyzed 114 participants
-46.8  (64.57)
Week 96 Number Analyzed 114 participants
-45.5  (70.63)
Week 108 Number Analyzed 114 participants
-45.0  (74.15)
Week 120 Number Analyzed 114 participants
-45.9  (75.30)
Week 132 Number Analyzed 114 participants
-44.4  (78.09)
Week 144 Number Analyzed 114 participants
-45.4  (76.53)
Week 156 Number Analyzed 114 participants
-46.0  (76.17)
Week 168 Number Analyzed 114 participants
-46.1  (75.84)
Week 180 Number Analyzed 114 participants
-45.8  (75.96)
Week 192 Number Analyzed 114 participants
-45.8  (75.89)
Week 204 Number Analyzed 114 participants
-45.9  (75.96)
10.Primary Outcome
Title Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Hide Description The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
Arm/Group Title EW/EW/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 47.6
Week 4 46.0
Week 8 44.4
Week 12 42.9
Week 16 46.0
Week 20 50.8
Week 24 54.0
Week 36 58.7
Week 48 54.0
Week 60 52.4
Week 72 54.0
Week 84 52.4
Week 96 49.2
Week 108 54.0
Week 120 50.8
Week 132 46.0
Week 144 54.0
Week 156 52.4
Week 168 52.4
Week 180 52.4
Week 192 52.4
11.Primary Outcome
Title Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Hide Description The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
Arm/Group Title EW/EOW/EW EW/PBO/EW PBO/PBO/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
Overall Number of Participants Analyzed 65 64 84
Measure Type: Number
Unit of Measure: percentage of participants
Entry of M12-555 Number Analyzed 65 participants 64 participants 84 participants
40.0 21.9 22.6
Week 4 Number Analyzed 61 participants 58 participants 83 participants
47.5 43.1 44.6
Week 8 Number Analyzed 62 participants 63 participants 83 participants
45.2 47.6 51.8
Week 12 Number Analyzed 63 participants 63 participants 83 participants
41.3 54.0 51.8
Week 18 Number Analyzed 63 participants 63 participants 83 participants
47.6 50.8 55.4
Week 24 Number Analyzed 63 participants 63 participants 83 participants
42.9 47.6 54.2
Week 36 Number Analyzed 63 participants 63 participants 83 participants
49.2 47.6 55.4
Week 48 Number Analyzed 63 participants 63 participants 83 participants
47.6 50.8 56.6
Week 60 Number Analyzed 63 participants 63 participants 83 participants
47.6 50.8 50.6
Week 72 Number Analyzed 63 participants 63 participants 83 participants
47.6 42.9 50.6
Week 84 Number Analyzed 63 participants 63 participants 83 participants
50.8 46.0 48.2
Week 96 Number Analyzed 63 participants 63 participants 83 participants
50.8 55.6 48.2
Week 108 Number Analyzed 63 participants 63 participants 83 participants
50.8 42.9 50.6
Week 120 Number Analyzed 63 participants 63 participants 83 participants
42.9 47.6 45.8
Week 132 Number Analyzed 63 participants 63 participants 83 participants
41.3 47.6 48.2
Week 144 Number Analyzed 63 participants 63 participants 83 participants
41.3 50.8 47.0
Week 156 Number Analyzed 63 participants 63 participants 83 participants
39.7 46.0 49.4
Week 168 Number Analyzed 63 participants 63 participants 83 participants
41.3 49.2 48.2
Week 180 Number Analyzed 63 participants 63 participants 83 participants
41.3 49.2 48.2
Week 192 Number Analyzed 63 participants 63 participants 83 participants
41.3 49.2 48.2
12.Primary Outcome
Title Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3
Hide Description The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point
Arm/Group Title PBO/EW/EW
Hide Arm/Group Description:
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: percentage of participants
Entry of Period B Number Analyzed 79 participants
31.6
Week 12 Number Analyzed 64 participants
51.6
Week 24 Number Analyzed 76 participants
55.3
Week 36 Number Analyzed 77 participants
55.8
Week 48 Number Analyzed 77 participants
53.2
Week 60 Number Analyzed 77 participants
58.4
Week 72 Number Analyzed 77 participants
64.9
Week 84 Number Analyzed 77 participants
63.6
Week 96 Number Analyzed 77 participants
62.3
Week 108 Number Analyzed 78 participants
55.1
Week 120 Number Analyzed 78 participants
56.4
Week 132 Number Analyzed 78 participants
53.8
Week 144 Number Analyzed 78 participants
55.1
Week 156 Number Analyzed 78 participants
51.3
Week 168 Number Analyzed 78 participants
57.7
Week 180 Number Analyzed 78 participants
57.7
Week 192 Number Analyzed 78 participants
56.4
Week 204 Number Analyzed 78 participants
57.7
13.Primary Outcome
Title Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Hide Description The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
Arm/Group Title EW/EW/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in both Period A and Period B of the prior Phase 3 studies.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 56.0
Week 4 52.0
Week 8 48.0
Week 12 46.0
Week 16 40.0
Week 20 50.0
Week 24 46.0
Week 36 58.0
Week 48 56.0
Week 60 56.0
Week 72 56.0
Week 84 56.0
Week 96 54.0
Week 108 50.0
Week 120 48.0
Week 132 56.0
Week 144 56.0
Week 156 58.0
Week 168 56.0
Week 180 56.0
Week 192 56.0
14.Primary Outcome
Title Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Hide Description The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
Arm/Group Title EW/EOW/EW EW/PBO/EW PBO/PBO/EW
Hide Arm/Group Description:
All participants who received adalimumab 40 mg every week (EW) in Period A and 40 mg every other week (EOW) in Period B in the prior Phase 3 studies.
All participants who received adalimumab 40 mg every week (EW) in Period A and placebo in Period B in the prior Phase 3 studies.
All participants who received placebo in both Period A and Period B in prior phase 3 study M11-810.
Overall Number of Participants Analyzed 55 53 69
Measure Type: Number
Unit of Measure: percentage of participants
Entry of M12-555 Number Analyzed 55 participants 53 participants 69 participants
43.6 37.7 31.9
Week 4 Number Analyzed 51 participants 47 participants 68 participants
49.0 46.8 61.8
Week 8 Number Analyzed 52 participants 52 participants 68 participants
46.2 55.8 61.8
Week 12 Number Analyzed 53 participants 52 participants 68 participants
39.6 59.6 58.8
Week 18 Number Analyzed 53 participants 52 participants 68 participants
45.3 59.6 63.2
Week 24 Number Analyzed 53 participants 52 participants 68 participants
39.6 53.8 54.4
Week 36 Number Analyzed 53 participants 52 participants 68 participants
45.3 48.1 58.8
Week 48 Number Analyzed 53 participants 52 participants 68 participants
47.2 51.9 58.8
Week 60 Number Analyzed 53 participants 52 participants 68 participants
43.4 53.8 55.9
Week 72 Number Analyzed 53 participants 52 participants 68 participants
47.2 59.6 55.9
Week 84 Number Analyzed 53 participants 52 participants 68 participants
49.1 48.1 52.9
Week 96 Number Analyzed 53 participants 52 participants 68 participants
47.2 57.7 57.4
Week 108 Number Analyzed 53 participants 52 participants 68 participants
49.1 44.2 54.4
Week 120 Number Analyzed 53 participants 52 participants 68 participants
39.6 48.1 54.4
Week 132 Number Analyzed 53 participants 52 participants 68 participants
43.4 50.0 54.4
Week 144 Number Analyzed 53 participants 52 participants 68 participants
43.4 50.0 54.4
Week 156 Number Analyzed 53 participants 52 participants 68 participants
43.4 46.2 55.9
Week 168 Number Analyzed 53 participants 52 participants 68 participants
43.4 48.1 54.4
Week 180 Number Analyzed 53 participants 52 participants 68 participants
43.4 48.1 54.4
Week 192 Number Analyzed 53 participants 52 participants 68 participants
43.4 48.1 54.4
15.Primary Outcome
Title Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3
Hide Description The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.
Time Frame Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.
Arm/Group Title PBO/EW/EW
Hide Arm/Group Description:
All participants who received placebo in Period A and adalimumab 40 mg every week (EW) in Period B in prior phase 3 study M11-313.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: percentage of participants
Entry of Period B Number Analyzed 62 participants
30.6
Week 12 Number Analyzed 49 participants
59.2
Week 24 Number Analyzed 59 participants
61.0
Week 36 Number Analyzed 60 participants
61.7
Week 48 Number Analyzed 60 participants
53.3
Week 60 Number Analyzed 60 participants
60.0
Week 72 Number Analyzed 60 participants
58.3
Week 84 Number Analyzed 60 participants
60.0
Week 96 Number Analyzed 60 participants
61.7
Week 108 Number Analyzed 61 participants
62.3
Week 120 Number Analyzed 61 participants
62.3
Week 132 Number Analyzed 61 participants
59.0
Week 144 Number Analyzed 61 participants
60.7
Week 156 Number Analyzed 61 participants
55.7
Week 168 Number Analyzed 61 participants
62.3
Week 180 Number Analyzed 61 participants
62.3
Week 192 Number Analyzed 61 participants
60.7
Week 204 Number Analyzed 61 participants
62.3
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 225 weeks).
Adverse Event Reporting Description TEAEs and TESAEs were defined as AEs and SAEs with an onset date on or after the first dose of adalimumab in either M12-555 or in prior studies M11-313 or M11-810, excluding AEs and SAEs with onset date during a protocol-defined treatment gap.
 
Arm/Group Title All Adalimumab
Hide Arm/Group Description Participants who received at least 1 dose of adalimumab (40 mg every week) in M12-555.
All-Cause Mortality
All Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Adalimumab
Affected / at Risk (%)
Total   99/508 (19.49%) 
Blood and lymphatic system disorders   
LYMPHADENITIS  1  1/508 (0.20%) 
Cardiac disorders   
ANGINA PECTORIS  1  2/508 (0.39%) 
CARDIAC ARREST  1  1/508 (0.20%) 
CARDIAC FAILURE  1  1/508 (0.20%) 
PALPITATIONS  1  2/508 (0.39%) 
Congenital, familial and genetic disorders   
ODONTOGENIC CYST  1  1/508 (0.20%) 
Gastrointestinal disorders   
AUTOIMMUNE PANCREATITIS  1  1/508 (0.20%) 
CROHN'S DISEASE  1  1/508 (0.20%) 
INCARCERATED UMBILICAL HERNIA  1  1/508 (0.20%) 
PERITONEAL CYST  1  1/508 (0.20%) 
General disorders   
NON-CARDIAC CHEST PAIN  1  1/508 (0.20%) 
PYREXIA  1  1/508 (0.20%) 
Hepatobiliary disorders   
CHOLANGITIS  1  1/508 (0.20%) 
CHOLELITHIASIS  1  2/508 (0.39%) 
Infections and infestations   
APPENDICITIS  1  2/508 (0.39%) 
CELLULITIS  1  2/508 (0.39%) 
ERYSIPELAS  1  1/508 (0.20%) 
GROIN ABSCESS  1  1/508 (0.20%) 
INFECTION  1  1/508 (0.20%) 
PERITONITIS  1  1/508 (0.20%) 
PERITONSILLAR ABSCESS  1  1/508 (0.20%) 
PERIUMBILICAL ABSCESS  1  1/508 (0.20%) 
PILONIDAL CYST  1  2/508 (0.39%) 
PNEUMONIA  1  3/508 (0.59%) 
PNEUMONIA CHLAMYDIAL  1  1/508 (0.20%) 
PNEUMONIA VIRAL  1  1/508 (0.20%) 
POSTOPERATIVE WOUND INFECTION  1  2/508 (0.39%) 
PYELONEPHRITIS  1  1/508 (0.20%) 
SEPSIS  1  2/508 (0.39%) 
SEPTIC SHOCK  1  2/508 (0.39%) 
VULVAL ABSCESS  1  1/508 (0.20%) 
Injury, poisoning and procedural complications   
ACCIDENTAL OVERDOSE  1  1/508 (0.20%) 
ANKLE FRACTURE  1  2/508 (0.39%) 
BURNS SECOND DEGREE  1  1/508 (0.20%) 
CONTUSION  1  1/508 (0.20%) 
FOOT FRACTURE  1  1/508 (0.20%) 
JOINT INJURY  1  1/508 (0.20%) 
LOWER LIMB FRACTURE  1  1/508 (0.20%) 
MENISCUS INJURY  1  1/508 (0.20%) 
PROCEDURAL DIZZINESS  1  1/508 (0.20%) 
PROCEDURAL NAUSEA  1  1/508 (0.20%) 
PROCEDURAL PAIN  1  1/508 (0.20%) 
RADIAL HEAD DISLOCATION  1  1/508 (0.20%) 
SCAR  1  1/508 (0.20%) 
TENDON RUPTURE  1  1/508 (0.20%) 
UPPER LIMB FRACTURE  1  1/508 (0.20%) 
Investigations   
AUTOANTIBODY POSITIVE  1  1/508 (0.20%) 
BODY TEMPERATURE INCREASED  1  1/508 (0.20%) 
Metabolism and nutrition disorders   
OBESITY  1  3/508 (0.59%) 
TYPE 2 DIABETES MELLITUS  1  1/508 (0.20%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  1/508 (0.20%) 
INTERVERTEBRAL DISC PROTRUSION  1  2/508 (0.39%) 
JOINT INSTABILITY  1  1/508 (0.20%) 
MUSCLE SPASMS  1  1/508 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BREAST CANCER STAGE III  1  1/508 (0.20%) 
CARDIAC MYXOMA  1  1/508 (0.20%) 
HODGKIN'S DISEASE  1  1/508 (0.20%) 
INVASIVE BREAST CARCINOMA  1  1/508 (0.20%) 
METASTASES TO LIVER  1  1/508 (0.20%) 
PANCREATIC CARCINOMA  1  1/508 (0.20%) 
PAPILLARY CYSTADENOMA LYMPHOMATOSUM  1  1/508 (0.20%) 
SEMINOMA  1  1/508 (0.20%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  1/508 (0.20%) 
Nervous system disorders   
CEREBROVASCULAR ACCIDENT  1  1/508 (0.20%) 
COMA HEPATIC  1  1/508 (0.20%) 
HEMIPLEGIA  1  1/508 (0.20%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/508 (0.20%) 
Pregnancy, puerperium and perinatal conditions   
ABORTION SPONTANEOUS  1  1/508 (0.20%) 
Psychiatric disorders   
SUICIDAL IDEATION  1  2/508 (0.39%) 
Renal and urinary disorders   
ACUTE KIDNEY INJURY  1  2/508 (0.39%) 
URETERIC OBSTRUCTION  1  1/508 (0.20%) 
Reproductive system and breast disorders   
DYSFUNCTIONAL UTERINE BLEEDING  1  1/508 (0.20%) 
OVARIAN CYST  1  1/508 (0.20%) 
PELVIC PROLAPSE  1  1/508 (0.20%) 
UTERINE CYST  1  1/508 (0.20%) 
Respiratory, thoracic and mediastinal disorders   
ACUTE PULMONARY OEDEMA  1  1/508 (0.20%) 
ACUTE RESPIRATORY FAILURE  1  1/508 (0.20%) 
PLEURISY  1  1/508 (0.20%) 
PNEUMONITIS  1  1/508 (0.20%) 
RESPIRATORY DISTRESS  1  1/508 (0.20%) 
RESPIRATORY FAILURE  1  1/508 (0.20%) 
Skin and subcutaneous tissue disorders   
CUTIS LAXA  1  1/508 (0.20%) 
DERMATITIS CONTACT  1  1/508 (0.20%) 
HIDRADENITIS  1  29/508 (5.71%) 
PUSTULAR PSORIASIS  1  1/508 (0.20%) 
PYODERMA GANGRENOSUM  1  1/508 (0.20%) 
Social circumstances   
SEXUAL ABUSE  1  1/508 (0.20%) 
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/508 (0.20%) 
HYPERTENSION  1  2/508 (0.39%) 
HYPERTENSIVE CRISIS  1  1/508 (0.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Adalimumab
Affected / at Risk (%)
Total   349/508 (68.70%) 
Gastrointestinal disorders   
DIARRHOEA  1  33/508 (6.50%) 
NAUSEA  1  32/508 (6.30%) 
General disorders   
PYREXIA  1  29/508 (5.71%) 
Infections and infestations   
BRONCHITIS  1  37/508 (7.28%) 
GASTROENTERITIS  1  26/508 (5.12%) 
INFLUENZA  1  40/508 (7.87%) 
NASOPHARYNGITIS  1  92/508 (18.11%) 
SINUSITIS  1  29/508 (5.71%) 
UPPER RESPIRATORY TRACT INFECTION  1  84/508 (16.54%) 
URINARY TRACT INFECTION  1  40/508 (7.87%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  38/508 (7.48%) 
BACK PAIN  1  33/508 (6.50%) 
Nervous system disorders   
HEADACHE  1  80/508 (15.75%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  27/508 (5.31%) 
Skin and subcutaneous tissue disorders   
HIDRADENITIS  1  125/508 (24.61%) 
Vascular disorders   
HYPERTENSION  1  28/508 (5.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01635764     History of Changes
Other Study ID Numbers: M12-555
2011-003478-98 ( EudraCT Number )
First Submitted: March 2, 2012
First Posted: July 10, 2012
Results First Submitted: August 3, 2017
Results First Posted: September 5, 2017
Last Update Posted: January 24, 2018