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Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

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: NCT00918255
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Interventions Biological: adalimumab
Drug: Placebo
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Period Title: Overall Study
Started 51 52 51
Completed 45 52 46
Not Completed 6 0 5
Reason Not Completed
Adverse Event             1             0             0
Withdrawal by Subject             1             0             2
Lack of Efficacy             1             0             0
Lost to Follow-up             1             0             2
Exceeded allowed number of interventions             0             0             1
Non-compliance             1             0             0
Investigator discretion             1             0             0
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB Total
Hide Arm/Group Description Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15. Total of all reporting groups
Overall Number of Baseline Participants 51 52 51 154
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 51 participants 154 participants
35.1  (10.69) 36.1  (12.50) 37.8  (12.10) 36.3  (11.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 51 participants 154 participants
Female
36
  70.6%
38
  73.1%
36
  70.6%
110
  71.4%
Male
15
  29.4%
14
  26.9%
15
  29.4%
44
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 51 participants 154 participants
United States 41 39 36 116
Europe 10 13 15 38
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 16
Hide Description Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Measure Type: Number
Unit of Measure: percentage of participants
17.6 9.6 3.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
2.Secondary Outcome
Title Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Hide Description Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 49 48 48
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-50.66  (11.364) -30.43  (11.452) -13.66  (11.452)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method ANCOVA
Comments Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).
3.Secondary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 2
Hide Description Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 9.6 2.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
4.Secondary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 4
Hide Description Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Measure Type: Number
Unit of Measure: percentage of participants
11.8 5.8 2.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
5.Secondary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 8
Hide Description Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Measure Type: Number
Unit of Measure: percentage of participants
7.8 5.8 7.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
6.Secondary Outcome
Title Percentage of Participants Achieving Clinical Response at Week 12
Hide Description Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Measure Type: Number
Unit of Measure: percentage of participants
21.6 7.7 5.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.721
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Analyzed using CMH test stratified by Hurley Stage.
7.Secondary Outcome
Title Change From Baseline in Modified Sartorius Scale at Week 16
Hide Description The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description:
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Overall Number of Participants Analyzed 51 52 51
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
-30.0
(-50.0 to -7.0)
-16.0
(-47.0 to 0.0)
-7.5
(-30.0 to 10.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.
Method Van Elteren test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Qwk DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Van Elteren test
Comments Analyzed using Van Elteren test stratified by Hurley Stage.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab 40 mg Eow DB, Placebo DB
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method Van Elteren test
Comments Analyzed using Van Elteren test stratified by Hurley Stage.
8.Secondary Outcome
Title Change From Baseline in Modified Sartorius Scale at Week 52
Hide Description The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
Hide Description Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Time Frame Baseline, Week 52
Outcome Measure Data Not Reported
Time Frame For the 3 treatment groups in Period 1 (Adalimumab 40 mg Qwk, Adalimumab 40 mg Eow, and Placebo): Week 0 up to Week 16. For Open-label adalimumab (Period 2): Week 16 through Week 52 plus 70 days after the last dose.
Adverse Event Reporting Description Assessment and recording of adverse events and serious adverse events was performed by the investigator at each study visit. Information on events that occurred 70-days after the last dose of study drug (Week 52 or early termination) was collected during a follow-up phone call.
 
Arm/Group Title Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Hide Arm/Group Description Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
All-Cause Mortality
Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/51 (7.84%)   3/52 (5.77%)   2/51 (3.92%) 
Blood and lymphatic system disorders       
Anaemia  1  1/51 (1.96%)  0/52 (0.00%)  0/51 (0.00%) 
Gastrointestinal disorders       
Small intestinal obstruction  1  0/51 (0.00%)  0/52 (0.00%)  1/51 (1.96%) 
General disorders       
Non-cardiac chest pain  1  1/51 (1.96%)  0/52 (0.00%)  0/51 (0.00%) 
Infections and infestations       
Escherichia infection  1  1/51 (1.96%)  0/52 (0.00%)  0/51 (0.00%) 
Genital infection bacterial  1  1/51 (1.96%)  0/52 (0.00%)  0/51 (0.00%) 
Pilonidal cyst  1  0/51 (0.00%)  1/52 (1.92%)  0/51 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Vocal cord neoplasm  1  1/51 (1.96%)  0/52 (0.00%)  0/51 (0.00%) 
Psychiatric disorders       
Suicide attempt  1  0/51 (0.00%)  0/52 (0.00%)  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  1  0/51 (0.00%)  1/52 (1.92%)  0/51 (0.00%) 
Skin and subcutaneous tissue disorders       
Hidradenitis  1  0/51 (0.00%)  1/52 (1.92%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Adalimumab 40 mg Qwk DB Adalimumab 40 mg Eow DB Placebo DB
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/51 (70.59%)   33/52 (63.46%)   30/51 (58.82%) 
Gastrointestinal disorders       
Gastrooesophageal reflux disease  1  3/51 (5.88%)  0/52 (0.00%)  0/51 (0.00%) 
Nausea  1  4/51 (7.84%)  2/52 (3.85%)  1/51 (1.96%) 
Vomiting  1  1/51 (1.96%)  2/52 (3.85%)  3/51 (5.88%) 
Abdominal pain upper  1  1/51 (1.96%)  2/52 (3.85%)  1/51 (1.96%) 
Diarrhoea  1  0/51 (0.00%)  2/52 (3.85%)  2/51 (3.92%) 
General disorders       
Fatigue  1  3/51 (5.88%)  2/52 (3.85%)  2/51 (3.92%) 
Injection site pruritus  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Oedema peripheral  1  0/51 (0.00%)  1/52 (1.92%)  2/51 (3.92%) 
Pain  1  0/51 (0.00%)  2/52 (3.85%)  0/51 (0.00%) 
Pyrexia  1  0/51 (0.00%)  2/52 (3.85%)  1/51 (1.96%) 
Infections and infestations       
Folliculitis  1  0/51 (0.00%)  0/52 (0.00%)  3/51 (5.88%) 
Nasopharyngitis  1  6/51 (11.76%)  7/52 (13.46%)  6/51 (11.76%) 
Upper respiratory tract infection  1  4/51 (7.84%)  4/52 (7.69%)  2/51 (3.92%) 
Bronchitis  1  1/51 (1.96%)  0/52 (0.00%)  2/51 (3.92%) 
Ear infection  1  0/51 (0.00%)  0/52 (0.00%)  2/51 (3.92%) 
Herpes simplex  1  0/51 (0.00%)  2/52 (3.85%)  0/51 (0.00%) 
Influenza  1  2/51 (3.92%)  1/52 (1.92%)  0/51 (0.00%) 
Sinusitis  1  2/51 (3.92%)  0/52 (0.00%)  1/51 (1.96%) 
Tonsillitis  1  0/51 (0.00%)  0/52 (0.00%)  2/51 (3.92%) 
Investigations       
Blood cholesterol increased  1  0/51 (0.00%)  0/52 (0.00%)  2/51 (3.92%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  1/51 (1.96%)  2/52 (3.85%)  0/51 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/51 (5.88%)  0/52 (0.00%)  1/51 (1.96%) 
Myalgia  1  1/51 (1.96%)  1/52 (1.92%)  2/51 (3.92%) 
Nervous system disorders       
Headache  1  8/51 (15.69%)  7/52 (13.46%)  2/51 (3.92%) 
Dizziness  1  0/51 (0.00%)  1/52 (1.92%)  2/51 (3.92%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/51 (5.88%)  1/52 (1.92%)  0/51 (0.00%) 
Oropharyngeal pain  1  1/51 (1.96%)  3/52 (5.77%)  1/51 (1.96%) 
Dyspnoea  1  0/51 (0.00%)  2/52 (3.85%)  0/51 (0.00%) 
Sinus congestion  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Skin and subcutaneous tissue disorders       
Hidradenitis  1  4/51 (7.84%)  6/52 (11.54%)  6/51 (11.76%) 
Pruritus  1  1/51 (1.96%)  3/52 (5.77%)  0/51 (0.00%) 
Dermatitis allergic  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Pityriasis rosea  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Psoriasis  1  0/51 (0.00%)  0/52 (0.00%)  2/51 (3.92%) 
Rash  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Urticaria  1  2/51 (3.92%)  0/52 (0.00%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
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Responsible Party: Martin Okun, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00918255     History of Changes
Other Study ID Numbers: M10-467
2008-004587-38 ( EudraCT Number )
First Submitted: April 30, 2009
First Posted: June 11, 2009
Results First Submitted: March 2, 2011
Results First Posted: May 9, 2011
Last Update Posted: May 9, 2011