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Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01265823
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Biological: Adalimumab
Enrollment 150
Recruitment Details  
Pre-assignment Details A total of 187 participants were screened and 37 were considered screening failures.
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Period Title: Overall Study
Started 150
Completed 143
Not Completed 7
Reason Not Completed
Unsatisfactory Response Efficacy             1
Failure to Return             4
Protocol Violation             1
Participant Request             1
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
44.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
37
  24.7%
Male
113
  75.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 150 participants
150
1.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
31
2.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
85
3.Primary Outcome
Title Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant’s life.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
65
4.Primary Outcome
Title Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
86
5.Secondary Outcome
Title Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score at Baseline 11.7  (6.3)
Score at Week 4 5.2  (6.4)
6.Secondary Outcome
Title Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: units on a scale
Score at Baseline 11.7  (6.3)
Score at Week 16 1.8  (2.0)
7.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Categories at Week 4
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
No Effect 42
Small Effect 52
Moderate Effect 32
Very Large Effect 18
Extremely Large Effect 3
Missing 3
8.Secondary Outcome
Title Dermatology Life Quality Index (DLQI) Categories at Week 16
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
No Effect 105
Small Effect 18
Moderate Effect 15
Very Large Effect 6
Extremely Large Effect 0
Missing 6
9.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
PASI-50 58.6
PASI-90 10.6
PASI-100 2.0
10.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: percentage of participants
PASI-50 92.6
PASI-90 73.3
PASI-100 49.3
11.Secondary Outcome
Title Physician's Global Assessment (PGA) at Week 4
Hide Description The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
Severe 3
Moderate to Severe 12
Moderate 44
Mild to Moderate 37
Mild 36
Almost Clear 11
Clear 3
Missing 4
12.Secondary Outcome
Title Physician’s Global Assessment (PGA) at Week 16
Hide Description The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants with missing scores were considered nonresponders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
Severe 1
Moderate to Severe 1
Moderate 9
Mild to Moderate 8
Mild 9
Almost Clear 44
Clear 71
Missing 7
13.Secondary Outcome
Title Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16
Hide Description Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 144
Mean (Standard Deviation)
Unit of Measure: mg/dL
C-reactive Protein at Baseline 0.6  (0.9)
C-reactive Protein at Week 16 0.5  (1.6)
Cholesterol at Baseline 190.7  (38.8)
Cholesterol at Week 16 185.3  (33.8)
High Density Lipoprotein (HDL) at Baseline 41.6  (9.7)
High Density Lipoprotein (HDL) at Week 16 42.6  (10.8)
Very Low Density Lipoprotein (VLDL) at Baseline 37.7  (26.3)
Very Low Density Lipoprotein (VLDL) at Week 16 37.8  (20.9)
Low Density Lipoprotein (LDL) at Baseline 120.8  (28.7)
Low Density Lipoprotein (LDL) at Week 16 120.3  (29.9)
Triglycerides at Baseline 185.3  (123.1)
Triglycerides at Week 16 189.1  (104.3)
14.Secondary Outcome
Title Mean Homocysteine Levels at Baseline and Week 16
Hide Description Normal values for homocysteine were 5-13.9 µmol/L.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: µmol/L
Baseline 11.6  (4.3)
Week 16 10.9  (4.0)
15.Secondary Outcome
Title Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
Hide Description The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Adalimumab in Obese Participants Adalimumab in Non-obese Participants
Hide Arm/Group Description:
Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 66 84
Measure Type: Number
Unit of Measure: percentage of participants
PASI-75 76 92
DLQI <6 80 90
16.Secondary Outcome
Title Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
Hide Description The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Adalimumab in Obese Participants Adalimumab in Non-obese Participants
Hide Arm/Group Description:
Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 66 84
Measure Type: Number
Unit of Measure: percentage of participants
PASI-75 77 91
DLQI <6 84 87
17.Secondary Outcome
Title Serum Levels of Folic Acid at Baseline and Week 4
Hide Description Normal values for folic acid were 3-15 ng/mL.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 18.1  (20.0)
Week 4 17.8  (11.4)
18.Secondary Outcome
Title Serum Levels of Vitamin B6 at Baseline and Week 4
Hide Description Normal values for vitamin B6 were 18-175 nmol/L.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline 11.2  (12.5)
Week 4 11.7  (11.6)
19.Secondary Outcome
Title Serum Levels of Vitamin B12 at Baseline and Week 4
Hide Description Normal values for vitamin B12 were 200-1100 pg/mL.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 542.6  (615.5)
Week 4 439.6  (438.9)
20.Secondary Outcome
Title Serum Levels of Folic Acid at Baseline and Week 16
Hide Description Normal values for folic acid were 3-15 ng/mL.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time point.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 140
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 18.2  (20.2)
Week 16 17.9  (7.1)
21.Secondary Outcome
Title Serum Levels of Vitamin B6 at Baseline and Week 16
Hide Description Normal values for vitamin B6 were 18-175 nmol/L.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: nmol/L
Baseline 11.4  (12.6)
Week 16 11.8  (7.6)
22.Secondary Outcome
Title Serum Levels of Vitamin B12 at Baseline and Week 16
Hide Description Normal values for vitamin B12 were 200-1100 pg/mL.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data at given time points.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Overall Number of Participants Analyzed 140
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 541.9  (620.5)
Week 16 441.8  (533.8)
Time Frame Adverse events were collected from start of study through 70 days after the last treatment. Treatment duration was 15 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   1/150 (0.67%) 
Gastrointestinal disorders   
Cholelithiasis  1  1/150 (0.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%)
Total   86/150 (57.33%) 
Blood and lymphatic system disorders   
Anemia  1  3/150 (2.00%) 
Leukopenia  1  1/150 (0.67%) 
Polycythemia  1  1/150 (0.67%) 
Thrombocytopenia  1  1/150 (0.67%) 
Cardiac disorders   
Aortic arteriosclerosis  1  1/150 (0.67%) 
Chest pain precordial  1  1/150 (0.67%) 
Hypertension aggravated  1  1/150 (0.67%) 
Ear and labyrinth disorders   
Otitis externa  1  1/150 (0.67%) 
Otitis media  1  1/150 (0.67%) 
Vertigo  1  1/150 (0.67%) 
Eye disorders   
Corneal injury  1  1/150 (0.67%) 
Gastrointestinal disorders   
Abdominal pain  1  1/150 (0.67%) 
Cholelithiasis  1  1/150 (0.67%) 
Diarrhoea  1  2/150 (1.33%) 
Epigastric discomfort  1  1/150 (0.67%) 
Flatulence  1  2/150 (1.33%) 
Food poisoning  1  1/150 (0.67%) 
Gastrointestinal infection  1  2/150 (1.33%) 
Nausea  1  1/150 (0.67%) 
Oral infection  1  1/150 (0.67%) 
Vomiting  1  1/150 (0.67%) 
General disorders   
Application site pain and/or pruritus  1  7/150 (4.67%) 
Fatigue  1  4/150 (2.67%) 
Fever  1  1/150 (0.67%) 
Pruritus generalized  1  1/150 (0.67%) 
Psoriasis aggravated  1  2/150 (1.33%) 
Skin disorder  1  1/150 (0.67%) 
Skin nodule  1  1/150 (0.67%) 
Infections and infestations   
Vaginal infection  1  1/150 (0.67%) 
Metabolism and nutrition disorders   
C-Reactive Protein increase  1  2/150 (1.33%) 
Diabetes  1  1/150 (0.67%) 
Hyperglycemia  1  16/150 (10.67%) 
Hypertransaminasemia  1  1/150 (0.67%) 
Hypertriglyceridemia  1  7/150 (4.67%) 
Hypervitaminosis B12  1  3/150 (2.00%) 
Hypervitaminosis B6  1  2/150 (1.33%) 
Hypoglycemia  1  2/150 (1.33%) 
Weight loss  1  1/150 (0.67%) 
Musculoskeletal and connective tissue disorders   
Ankle sprain  1  1/150 (0.67%) 
Arthralgia  1  10/150 (6.67%) 
Back pain  1  1/150 (0.67%) 
Joint injury  1  1/150 (0.67%) 
Nervous system disorders   
Seizures  1  1/150 (0.67%) 
Dizziness  1  1/150 (0.67%) 
Headache  1  8/150 (5.33%) 
Psychiatric disorders   
Anxiety  1  1/150 (0.67%) 
Depressed mood  1  1/150 (0.67%) 
Depression  1  1/150 (0.67%) 
Renal and urinary disorders   
Calculus urethral  1  1/150 (0.67%) 
Nefrolithiasis  1  1/150 (0.67%) 
Penis disorder  1  1/150 (0.67%) 
Prostatitis  1  1/150 (0.67%) 
Urinary tract infection  1  1/150 (0.67%) 
Urinary tract pain  1  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Pharyngitis  1  6/150 (4.00%) 
Upper respiratory tract infection  1  17/150 (11.33%) 
Skin and subcutaneous tissue disorders   
Cold sores (herpetic)  1  1/150 (0.67%) 
Folliculitis  1  1/150 (0.67%) 
Papillomatosis  1  1/150 (0.67%) 
Urticaria  1  1/150 (0.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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 Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01265823     History of Changes
Other Study ID Numbers: W11-050
First Submitted: December 22, 2010
First Posted: December 23, 2010
Results First Submitted: February 1, 2013
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013