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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01468233
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 326
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/Placebo 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 placebo every week 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 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 40 mg adalimumab 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 163 163 0 0 0 0
Completed 151 155 0 0 0 0
Not Completed 12 8 0 0 0 0
Reason Not Completed
Adverse Event             5             3             0             0             0             0
Withdrawal by Subject             3             4             0             0             0             0
Lost to Follow-up             3             0             0             0             0             0
Other             1             1             0             0             0             0
Period Title: Treatment Period 2
Started 0 0 151 51 53 51
Completed 0 0 40 23 25 28
Not Completed 0 0 111 28 28 23
Reason Not Completed
Adverse Event             0             0             3             0             2             1
Lack of Efficacy             0             0             9             2             0             1
Withdrawal by Subject             0             0             9             1             1             1
Loss/absence of response (per protocol)             0             0             84             25             22             20
Lost to Follow-up             0             0             3             0             2             0
Other             0             0             3             0             1             0
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 163 163 326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 163 participants 326 participants
36.1  (12.18) 34.9  (9.96) 35.5  (11.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 163 participants 326 participants
Female
113
  69.3%
108
  66.3%
221
  67.8%
Male
50
  30.7%
55
  33.7%
105
  32.2%
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
Hide 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 163 163 87 76 85 78
Measure Type: Number
Unit of Measure: percentage of participants
27.6 58.9 36.8 17.1 62.4 55.1
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 <0.001
Comments P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 31.5
Confidence Interval (2-Sided) 95%
20.7 to 42.2
Estimation Comments [Not Specified]
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 <0.001
Comments P-value adjusted for baseline antibiotic use (Y/N).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 25.5
Confidence Interval (2-Sided) 95%
10.5 to 40.5
Estimation Comments [Not Specified]
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 <0.001
Comments P-value adjusted for baseline antibiotic use (Y/N).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 38.1
Confidence Interval (2-Sided) 95%
22.8 to 53.3
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 nonresponders.
Time Frame Baseline (Week 0) up to Week 12
Hide 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 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 87 85
Measure Type: Number
Unit of Measure: percentage of participants
32.2 51.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo - Baseline Hurley Stage II, 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 =0.01
Comments P-value adjusted for baseline antibiotics use (Y/N).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
4.7 to 34.2
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 is 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
Hide 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 Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (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 111 105
Measure Type: Number
Unit of Measure: percentage of participants
20.7 45.7
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 <0.001
Comments P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 25.1
Confidence Interval (2-Sided) 95%
12.7 to 37.6
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
Hide 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 162 163
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.5  (3.84) -28.9  (3.85)
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 <0.001
Comments P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.4
Confidence Interval (2-Sided) 95%
-28.6 to -10.1
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/Placebo (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 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 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 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 40 mg adalimumab 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).
All-Cause Mortality
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Placebo (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   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Placebo (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   6/163 (3.68%)   3/163 (1.84%)   7/151 (4.64%)   0/51 (0.00%)   2/53 (3.77%)   2/51 (3.92%) 
Blood and lymphatic system disorders             
ANAEMIA  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
LYMPHADENITIS  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  1/53 (1.89%)  0/51 (0.00%) 
Cardiac disorders             
ACUTE MYOCARDIAL INFARCTION  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  1/53 (1.89%)  0/51 (0.00%) 
ATRIAL FIBRILLATION  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
CARDIO-RESPIRATORY ARREST  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  1/53 (1.89%)  0/51 (0.00%) 
General disorders             
FATIGUE  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Infections and infestations             
APPENDICITIS  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
CLOSTRIDIUM DIFFICILE INFECTION  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
GASTROENTERITIS  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
INFECTION  1  0/163 (0.00%)  1/163 (0.61%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
PNEUMONIA  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  1/51 (1.96%) 
VIRAL INFECTION  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Injury, poisoning and procedural complications             
ACCIDENTAL OVERDOSE  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
TENDON RUPTURE  1  0/163 (0.00%)  1/163 (0.61%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Investigations             
INTERNATIONAL NORMALISED RATIO INCREASED  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Metabolism and nutrition disorders             
DIABETES MELLITUS INADEQUATE CONTROL  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Nervous system disorders             
DIZZINESS  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
PRESYNCOPE  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Psychiatric disorders             
DEPRESSION  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
SUICIDE ATTEMPT  1  1/163 (0.61%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Renal and urinary disorders             
RENAL COLIC  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
RENAL FAILURE ACUTE  1  0/163 (0.00%)  1/163 (0.61%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Skin and subcutaneous tissue disorders             
HIDRADENITIS  1  2/163 (1.23%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  1/53 (1.89%)  0/51 (0.00%) 
RASH  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  1/51 (1.96%) 
Social circumstances             
SEXUAL ABUSE  1  0/163 (0.00%)  1/163 (0.61%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Surgical and medical procedures             
ABORTION INDUCED  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Vascular disorders             
INTRA-ABDOMINAL HAEMATOMA  1  0/163 (0.00%)  0/163 (0.00%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo (Period 1) Adalimumab EW (Period 1) Placebo/Placebo (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   77/163 (47.24%)   66/163 (40.49%)   48/151 (31.79%)   27/51 (52.94%)   25/53 (47.17%)   21/51 (41.18%) 
Eye disorders             
CONJUNCTIVITIS  1  1/163 (0.61%)  0/163 (0.00%)  2/151 (1.32%)  2/51 (3.92%)  1/53 (1.89%)  1/51 (1.96%) 
Gastrointestinal disorders             
DIARRHOEA  1  4/163 (2.45%)  9/163 (5.52%)  2/151 (1.32%)  1/51 (1.96%)  4/53 (7.55%)  1/51 (1.96%) 
NAUSEA  1  5/163 (3.07%)  7/163 (4.29%)  0/151 (0.00%)  1/51 (1.96%)  1/53 (1.89%)  1/51 (1.96%) 
TOOTHACHE  1  1/163 (0.61%)  2/163 (1.23%)  3/151 (1.99%)  3/51 (5.88%)  0/53 (0.00%)  1/51 (1.96%) 
VOMITING  1  2/163 (1.23%)  4/163 (2.45%)  0/151 (0.00%)  0/51 (0.00%)  2/53 (3.77%)  0/51 (0.00%) 
General disorders             
ASTHENIA  1  6/163 (3.68%)  0/163 (0.00%)  2/151 (1.32%)  1/51 (1.96%)  0/53 (0.00%)  0/51 (0.00%) 
FATIGUE  1  2/163 (1.23%)  5/163 (3.07%)  0/151 (0.00%)  1/51 (1.96%)  0/53 (0.00%)  1/51 (1.96%) 
INJECTION SITE PAIN  1  5/163 (3.07%)  6/163 (3.68%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
PYREXIA  1  2/163 (1.23%)  1/163 (0.61%)  2/151 (1.32%)  1/51 (1.96%)  2/53 (3.77%)  1/51 (1.96%) 
Infections and infestations             
BRONCHITIS  1  4/163 (2.45%)  2/163 (1.23%)  2/151 (1.32%)  3/51 (5.88%)  0/53 (0.00%)  1/51 (1.96%) 
FOLLICULITIS  1  0/163 (0.00%)  4/163 (2.45%)  0/151 (0.00%)  1/51 (1.96%)  0/53 (0.00%)  2/51 (3.92%) 
GASTROENTERITIS  1  3/163 (1.84%)  5/163 (3.07%)  7/151 (4.64%)  1/51 (1.96%)  2/53 (3.77%)  1/51 (1.96%) 
GASTROENTERITIS VIRAL  1  1/163 (0.61%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  2/53 (3.77%)  3/51 (5.88%) 
INFLUENZA  1  3/163 (1.84%)  3/163 (1.84%)  3/151 (1.99%)  2/51 (3.92%)  0/53 (0.00%)  3/51 (5.88%) 
NASOPHARYNGITIS  1  10/163 (6.13%)  9/163 (5.52%)  5/151 (3.31%)  1/51 (1.96%)  3/53 (5.66%)  3/51 (5.88%) 
PHARYNGITIS  1  0/163 (0.00%)  3/163 (1.84%)  0/151 (0.00%)  0/51 (0.00%)  2/53 (3.77%)  0/51 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  9/163 (5.52%)  8/163 (4.91%)  13/151 (8.61%)  5/51 (9.80%)  4/53 (7.55%)  1/51 (1.96%) 
URINARY TRACT INFECTION  1  5/163 (3.07%)  1/163 (0.61%)  3/151 (1.99%)  1/51 (1.96%)  1/53 (1.89%)  0/51 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  0/53 (0.00%)  2/51 (3.92%) 
Metabolism and nutrition disorders             
DIABETES MELLITUS  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  0/51 (0.00%)  2/53 (3.77%)  1/51 (1.96%) 
VITAMIN D DEFICIENCY  1  0/163 (0.00%)  0/163 (0.00%)  0/151 (0.00%)  1/51 (1.96%)  2/53 (3.77%)  0/51 (0.00%) 
Musculoskeletal and connective tissue disorders             
BACK PAIN  1  3/163 (1.84%)  3/163 (1.84%)  4/151 (2.65%)  0/51 (0.00%)  1/53 (1.89%)  2/51 (3.92%) 
MUSCLE SPASMS  1  1/163 (0.61%)  2/163 (1.23%)  1/151 (0.66%)  2/51 (3.92%)  0/53 (0.00%)  0/51 (0.00%) 
Nervous system disorders             
DIZZINESS  1  1/163 (0.61%)  7/163 (4.29%)  1/151 (0.66%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
HEADACHE  1  21/163 (12.88%)  21/163 (12.88%)  4/151 (2.65%)  4/51 (7.84%)  3/53 (5.66%)  5/51 (9.80%) 
Psychiatric disorders             
INSOMNIA  1  4/163 (2.45%)  1/163 (0.61%)  2/151 (1.32%)  0/51 (0.00%)  0/53 (0.00%)  0/51 (0.00%) 
Skin and subcutaneous tissue disorders             
DERMATITIS CONTACT  1  2/163 (1.23%)  0/163 (0.00%)  3/151 (1.99%)  2/51 (3.92%)  0/53 (0.00%)  0/51 (0.00%) 
ERYTHEMA  1  0/163 (0.00%)  1/163 (0.61%)  0/151 (0.00%)  0/51 (0.00%)  2/53 (3.77%)  0/51 (0.00%) 
HIDRADENITIS  1  19/163 (11.66%)  7/163 (4.29%)  13/151 (8.61%)  10/51 (19.61%)  8/53 (15.09%)  3/51 (5.88%) 
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
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Name/Title: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01468233    
Other Study ID Numbers: M11-810
2011-003406-24 ( 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