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Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER I)

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ClinicalTrials.gov Identifier: NCT01468207
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa (HS)
Interventions Biological: adalimumab
Biological: placebo
Enrollment 307
Recruitment Details Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.
Pre-assignment Details  
Arm/Group Title Placebo Adalimumab Every Week (EW) Placebo/Adalimumab Every Week (EW) Adalimumab Every Week (EW)/Placebo Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW) Adalimumab Every Week (EW)/Adalimumab Every Week (EW)
Hide Arm/Group Description Placebo for 12 weeks. Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks). Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Period Title: Treatment Period 1
Started 154 153 0 0 0 0
Received Study Drug 152 153 0 0 0 0
Completed 145 145 0 0 0 0
Not Completed 9 8 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0
Protocol Violation             1             1             0             0             0             0
Withdrawal by Subject             5             4             0             0             0             0
Lost to Follow-up             2             1             0             0             0             0
Not specified             0             2             0             0             0             0
Period Title: Treatment Period 2
Started 0 0 145 49 48 48
Completed 0 0 93 22 27 28
Not Completed 0 0 52 27 21 20
Reason Not Completed
Adverse Event             0             0             6             1             2             1
Lack of Efficacy             0             0             1             1             0             2
Withdrawal by Subject             0             0             5             0             0             2
Loss/abscence of response (per protocol)             0             0             30             23             18             13
Lost to Follow-up             0             0             5             1             0             0
Not specified             0             0             5             1             1             2
Arm/Group Title Placebo Adalimumab Every Week (EW) Total
Hide Arm/Group Description Placebo for 12 weeks. Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). Total of all reporting groups
Overall Number of Baseline Participants 154 153 307
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 153 participants 307 participants
37.8  (11.33) 36.2  (10.83) 37.0  (11.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 153 participants 307 participants
Female
105
  68.2%
91
  59.5%
196
  63.8%
Male
49
  31.8%
62
  40.5%
111
  36.2%
1.Primary Outcome
Title Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Hide Description HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.
Time Frame Baseline (Week 0) up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage
Arm/Group Title Placebo Adalimumab Every Week (EW) Placebo - Baseline Hurley Stage II Placebo - Baseline Hurley Stage III Adalimumab Every Week (EW) - Baseline Hurley Stage II Adalimumab Every Week (ew) - Baseline Hurley Stage III
Hide Arm/Group Description:
Placebo for 12 weeks.
Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
Overall Number of Participants Analyzed 154 153 84 70 83 70
Measure Type: Number
Unit of Measure: percentage of participants
26.0 41.8 29.8 21.4 44.6 38.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab Every Week (EW)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments P-value adjusted for baseline Hurley Stage.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 15.9
Confidence Interval (2-Sided) 95%
5.3 to 26.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo - Baseline Hurley Stage II, Adalimumab Every Week (EW) - Baseline Hurley Stage II
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.048
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.8
Confidence Interval (2-Sided) 95%
0.3 to 29.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo - Baseline Hurley Stage III, Adalimumab Every Week (ew) - Baseline Hurley Stage III
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.027
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.1
Confidence Interval (2-Sided) 95%
2.2 to 32.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
Hide Description The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders.
Time Frame Baseline (Week 0) up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population with baseline Hurley Stage II
Arm/Group Title Placebo - Baseline Hurley Stage II Adalimumab Every Week (EW) - Baseline Hurley Stage II
Hide Arm/Group Description:
Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
Overall Number of Participants Analyzed 84 83
Measure Type: Number
Unit of Measure: percentage of participants
28.6 28.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Baseline Hurley Stage II, Adalimumab Every Week (EW) - Baseline Hurley Stage II
Comments Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.961
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-13.4 to 14.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 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 Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.
Time Frame Baseline (Week 0) up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population with baseline NRS at Worst ≥ 3
Arm/Group Title Placebo - Baseline NRS at Worst ≥ 3 Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
Hide Arm/Group Description:
Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
Overall Number of Participants Analyzed 109 122
Measure Type: Number
Unit of Measure: percentage of participants
24.8 27.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Baseline NRS at Worst ≥ 3, Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3
Comments Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.628
Comments P-value adjusted for baseline Hurley Stage.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-8.6 to 14.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 12 in Modified Sartorius Score
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. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Time Frame Baseline (Week 0) and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population
Arm/Group Title Placebo Adalimumab Every Week (EW)
Hide Arm/Group Description:
Placebo for 12 weeks.
Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Overall Number of Participants Analyzed 151 153
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-15.7  (4) -24.4  (3.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab Every Week (EW)
Comments Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.124
Comments [Not Specified]
Method ANCOVA
Comments P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.7
Confidence Interval (2-Sided) 95%
-19.7 to 2.4
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); Serious Adverse Events were collected from the time that informed consent was obtained (up to 50 weeks).
Adverse Event Reporting Description Adverse Events with onset in Period 1 were collected from first dose of study drug until prior to the first dose in Period 2, or up to 70 days following last dose of study drug if the participant discontinued during Period 1.
 
Arm/Group Title Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
Hide Arm/Group Description Placebo for 12 weeks Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks). Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
All-Cause Mortality
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/152 (3.29%)   3/153 (1.96%)   5/145 (3.45%)   2/49 (4.08%)   3/48 (6.25%)   1/48 (2.08%) 
Gastrointestinal disorders             
ABDOMINAL PAIN  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
General disorders             
EFFUSION  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Infections and infestations             
PNEUMONIA  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
PYELONEPHRITIS  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Investigations             
HEPATITIS A ANTIBODY POSITIVE  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
LIVER FUNCTION TEST ABNORMAL  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders             
INTERVERTEBRAL DISC CALCIFICATION  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
TENDONITIS  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
INVASIVE DUCTAL BREAST CARCINOMA  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Pregnancy, puerperium and perinatal conditions             
ECTOPIC PREGNANCY  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
Respiratory, thoracic and mediastinal disorders             
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
Skin and subcutaneous tissue disorders             
HIDRADENITIS  1  3/152 (1.97%)  1/153 (0.65%)  2/145 (1.38%)  2/49 (4.08%)  2/48 (4.17%)  0/48 (0.00%) 
Surgical and medical procedures             
ABORTION INDUCED  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Adalimumab EW (Period 2) Adalimumab EW/Placebo (Period 2) Adalimumab EW/Adalimumab EOW (Period 2) Adalimumab EW/Adalimumab EW (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   81/152 (53.29%)   64/153 (41.83%)   68/145 (46.90%)   30/49 (61.22%)   24/48 (50.00%)   28/48 (58.33%) 
Blood and lymphatic system disorders             
ANAEMIA  1  1/152 (0.66%)  1/153 (0.65%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  2/48 (4.17%) 
LEUKOCYTOSIS  1  0/152 (0.00%)  0/153 (0.00%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
NEUTROPHILIA  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Ear and labyrinth disorders             
VERTIGO  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Endocrine disorders             
HYPOTHYROIDISM  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Eye disorders             
BLEPHARITIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
EYELID OEDEMA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
MEIBOMIAN GLAND DYSFUNCTION  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
VISUAL IMPAIRMENT  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Gastrointestinal disorders             
ABDOMINAL PAIN UPPER  1  3/152 (1.97%)  1/153 (0.65%)  1/145 (0.69%)  2/49 (4.08%)  0/48 (0.00%)  0/48 (0.00%) 
CONSTIPATION  1  2/152 (1.32%)  1/153 (0.65%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
DIARRHOEA  1  2/152 (1.32%)  3/153 (1.96%)  3/145 (2.07%)  1/49 (2.04%)  0/48 (0.00%)  1/48 (2.08%) 
DRY MOUTH  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
GASTRITIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  2/48 (4.17%) 
LIP SWELLING  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
NAUSEA  1  4/152 (2.63%)  3/153 (1.96%)  6/145 (4.14%)  0/49 (0.00%)  0/48 (0.00%)  2/48 (4.17%) 
TOOTHACHE  1  1/152 (0.66%)  0/153 (0.00%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
VOMITING  1  2/152 (1.32%)  1/153 (0.65%)  1/145 (0.69%)  1/49 (2.04%)  1/48 (2.08%)  1/48 (2.08%) 
General disorders             
CHILLS  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
FATIGUE  1  4/152 (2.63%)  3/153 (1.96%)  2/145 (1.38%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
INJECTION SITE BRUISING  1  0/152 (0.00%)  1/153 (0.65%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
INJECTION SITE ERYTHEMA  1  0/152 (0.00%)  1/153 (0.65%)  6/145 (4.14%)  0/49 (0.00%)  0/48 (0.00%)  0/48 (0.00%) 
INJECTION SITE PRURITUS  1  0/152 (0.00%)  1/153 (0.65%)  3/145 (2.07%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
LOCAL SWELLING  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
NON-CARDIAC CHEST PAIN  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
PYREXIA  1  3/152 (1.97%)  1/153 (0.65%)  2/145 (1.38%)  0/49 (0.00%)  3/48 (6.25%)  2/48 (4.17%) 
XEROSIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
Hepatobiliary disorders             
CHOLELITHIASIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Immune system disorders             
HYPERSENSITIVITY  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Infections and infestations             
BODY TINEA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
BRONCHITIS  1  2/152 (1.32%)  0/153 (0.00%)  3/145 (2.07%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
CELLULITIS  1  2/152 (1.32%)  2/153 (1.31%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
CYTOLYTIC VAGINOSIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
EAR INFECTION  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
FOLLICULITIS  1  1/152 (0.66%)  0/153 (0.00%)  2/145 (1.38%)  0/49 (0.00%)  1/48 (2.08%)  2/48 (4.17%) 
IMPETIGO  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
INFLUENZA  1  3/152 (1.97%)  2/153 (1.31%)  3/145 (2.07%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/152 (1.32%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  1/48 (2.08%)  0/48 (0.00%) 
MEASLES  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
NASOPHARYNGITIS  1  16/152 (10.53%)  9/153 (5.88%)  11/145 (7.59%)  9/49 (18.37%)  1/48 (2.08%)  3/48 (6.25%) 
ORAL HERPES  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
OTITIS MEDIA  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
PHARYNGITIS  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
PHARYNGITIS STREPTOCOCCAL  1  1/152 (0.66%)  1/153 (0.65%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
PNEUMONIA  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
POSTOPERATIVE WOUND INFECTION  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
RASH PUSTULAR  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
RHINITIS  1  1/152 (0.66%)  1/153 (0.65%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
SINUSITIS  1  1/152 (0.66%)  3/153 (1.96%)  4/145 (2.76%)  1/49 (2.04%)  0/48 (0.00%)  2/48 (4.17%) 
SKIN CANDIDA  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
TINEA INFECTION  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
TONSILLITIS  1  1/152 (0.66%)  1/153 (0.65%)  2/145 (1.38%)  1/49 (2.04%)  1/48 (2.08%)  0/48 (0.00%) 
TRACHEITIS  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/152 (2.63%)  5/153 (3.27%)  5/145 (3.45%)  2/49 (4.08%)  3/48 (6.25%)  4/48 (8.33%) 
URINARY TRACT INFECTION  1  3/152 (1.97%)  5/153 (3.27%)  4/145 (2.76%)  1/49 (2.04%)  2/48 (4.17%)  2/48 (4.17%) 
Injury, poisoning and procedural complications             
CONTUSION  1  2/152 (1.32%)  0/153 (0.00%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
EXCORIATION  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
FALL  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
LIGAMENT SPRAIN  1  1/152 (0.66%)  1/153 (0.65%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
ROAD TRAFFIC ACCIDENT  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
SKIN INJURY  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/152 (0.00%)  0/153 (0.00%)  2/145 (1.38%)  2/49 (4.08%)  0/48 (0.00%)  0/48 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/152 (0.00%)  1/153 (0.65%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
BLOOD GLUCOSE INCREASED  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
BLOOD TRIGLYCERIDES INCREASED  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
C-REACTIVE PROTEIN INCREASED  1  3/152 (1.97%)  3/153 (1.96%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
WEIGHT DECREASED  1  0/152 (0.00%)  2/153 (1.31%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  2/48 (4.17%) 
WEIGHT INCREASED  1  3/152 (1.97%)  3/153 (1.96%)  2/145 (1.38%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
WHITE BLOOD CELL COUNT DECREASED  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Metabolism and nutrition disorders             
DIABETES MELLITUS  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
HYPERGLYCAEMIA  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
HYPERLIPIDAEMIA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
HYPOKALAEMIA  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
TYPE 2 DIABETES MELLITUS  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
VITAMIN D DEFICIENCY  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  0/152 (0.00%)  3/153 (1.96%)  1/145 (0.69%)  3/49 (6.12%)  1/48 (2.08%)  1/48 (2.08%) 
BACK PAIN  1  4/152 (2.63%)  3/153 (1.96%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  1/48 (2.08%) 
INTERVERTEBRAL DISC DEGENERATION  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
JOINT SWELLING  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
MUSCULOSKELETAL STIFFNESS  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
MYALGIA  1  1/152 (0.66%)  2/153 (1.31%)  3/145 (2.07%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Nervous system disorders             
DIZZINESS  1  2/152 (1.32%)  4/153 (2.61%)  1/145 (0.69%)  1/49 (2.04%)  2/48 (4.17%)  0/48 (0.00%) 
HEADACHE  1  15/152 (9.87%)  14/153 (9.15%)  9/145 (6.21%)  4/49 (8.16%)  3/48 (6.25%)  2/48 (4.17%) 
LETHARGY  1  0/152 (0.00%)  1/153 (0.65%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
NERVE COMPRESSION  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
PARAESTHESIA  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
SINUS HEADACHE  1  1/152 (0.66%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
SYNCOPE  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
Psychiatric disorders             
DEPRESSION  1  0/152 (0.00%)  3/153 (1.96%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
INSOMNIA  1  1/152 (0.66%)  1/153 (0.65%)  1/145 (0.69%)  0/49 (0.00%)  1/48 (2.08%)  2/48 (4.17%) 
Renal and urinary disorders             
DYSURIA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
HAEMATURIA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Reproductive system and breast disorders             
VAGINAL HAEMORRHAGE  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
ASTHMA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
COUGH  1  3/152 (1.97%)  2/153 (1.31%)  2/145 (1.38%)  0/49 (0.00%)  1/48 (2.08%)  2/48 (4.17%) 
OROPHARYNGEAL PAIN  1  4/152 (2.63%)  2/153 (1.31%)  3/145 (2.07%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
RESPIRATORY TRACT CONGESTION  1  0/152 (0.00%)  1/153 (0.65%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
SINUS CONGESTION  1  1/152 (0.66%)  1/153 (0.65%)  1/145 (0.69%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
SNEEZING  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Skin and subcutaneous tissue disorders             
ACNE CYSTIC  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
ALOPECIA  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
DERMAL CYST  1  2/152 (1.32%)  0/153 (0.00%)  2/145 (1.38%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
DERMATITIS CONTACT  1  1/152 (0.66%)  0/153 (0.00%)  1/145 (0.69%)  0/49 (0.00%)  3/48 (6.25%)  0/48 (0.00%) 
DERMATITIS PAPILLARIS CAPILLITII  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
DERMATITIS PSORIASIFORM  1  0/152 (0.00%)  0/153 (0.00%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  1/48 (2.08%) 
ECZEMA  1  0/152 (0.00%)  1/153 (0.65%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
ECZEMA ASTEATOTIC  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
HIDRADENITIS  1  17/152 (11.18%)  13/153 (8.50%)  14/145 (9.66%)  8/49 (16.33%)  7/48 (14.58%)  2/48 (4.17%) 
INTERTRIGO  1  2/152 (1.32%)  1/153 (0.65%)  1/145 (0.69%)  1/49 (2.04%)  0/48 (0.00%)  2/48 (4.17%) 
KELOID SCAR  1  0/152 (0.00%)  0/153 (0.00%)  0/145 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/48 (0.00%) 
Vascular disorders             
HYPERTENSION  1  3/152 (1.97%)  1/153 (0.65%)  2/145 (1.38%)  2/49 (4.08%)  0/48 (0.00%)  1/48 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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 Information
Organization: AbbVie
Phone: 1-800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01468207     History of Changes
Other Study ID Numbers: M11-313
2011-003400-20 ( EudraCT Number )
First Submitted: November 7, 2011
First Posted: November 9, 2011
Results First Submitted: September 16, 2015
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015