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Trial record 28 of 272 for:    Betamethasone

Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

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: NCT00574249
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : January 18, 2010
Last Update Posted : April 13, 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 Chronic Plaque Psoriasis
Interventions Biological: adalimumab
Drug: Calcipotriol/Betamethasone Ointment
Drug: placebo (vehicle ointment)
Enrollment 730
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week) adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
Period Title: Overall Study
Started 364 366
Completed 338 338
Not Completed 26 28
Reason Not Completed
Adverse Event             6             18
Lack of Efficacy             5             3
Lost to Follow-up             4             3
Protocol Violation             5             2
History of carcinoma             1             0
Withdrawal by Subject             3             0
Physician Decision             1             0
Pregnancy             1             0
Excluded by company             0             1
PPD test taken twice             0             1
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone Total
Hide Arm/Group Description adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 adalimumab + calcipotriol/betamethasone ointment Total of all reporting groups
Overall Number of Baseline Participants 364 366 730
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 366 participants 730 participants
<=18 years
0
   0.0%
1
   0.3%
1
   0.1%
Between 18 and 65 years
343
  94.2%
350
  95.6%
693
  94.9%
>=65 years
21
   5.8%
15
   4.1%
36
   4.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 364 participants 366 participants 730 participants
44.8  (12.61) 45.3  (11.95) 45.1  (12.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 366 participants 730 participants
Female
113
  31.0%
116
  31.7%
229
  31.4%
Male
251
  69.0%
250
  68.3%
501
  68.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 364 participants 366 participants 730 participants
Austria 12 12 24
Belgium 40 36 76
Czech Republic 8 10 18
Denmark 15 15 30
Finland 5 6 11
France 58 61 119
Germany 79 83 162
Greece 12 12 24
Italy 32 34 66
Netherlands 17 18 35
Spain 33 26 59
Sweden 9 8 17
Switzerland 12 10 22
Turkey 14 14 28
United Kingdom 18 21 39
1.Primary Outcome
Title Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
Hide Description PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
70.9 64.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments Level of significance 5%; no adjustment for multiple comparisons necessary.
Method Cochran-Mantel-Haenszel
Comments Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).
2.Secondary Outcome
Title Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
Hide Description PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
82.7 80.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
Hide Description PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
50.3 38.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
Hide Description PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
24.2 15.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
Hide Description PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
7.1 13.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
Hide Description PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
24.5 33.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
Hide Description PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
46.2 42.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
Hide Description PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
64.8 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
Hide Description PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 364 366
Measure Type: Number
Unit of Measure: percentage of participants
64.6 56.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
Hide Description DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 354 363
Mean (Standard Deviation)
Unit of Measure: percent change in score
-71.46  (49.171) -67.20  (45.463)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
11.Secondary Outcome
Title Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
Hide Description DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Time Frame Week 0 and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 346 361
Mean (Standard Deviation)
Unit of Measure: percent change in score
-32.14  (44.118) -47.49  (41.093)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
12.Secondary Outcome
Title Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
Hide Description DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Time Frame Week 0 and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 354 362
Mean (Standard Deviation)
Unit of Measure: percent change in score
-46.64  (68.139) -60.93  (38.122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
13.Secondary Outcome
Title Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
Hide Description DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Time Frame Week 0 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 354 363
Mean (Standard Deviation)
Unit of Measure: percent change in score
-63.30  (45.404) -62.30  (43.087)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.764
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
14.Secondary Outcome
Title Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
Hide Description DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 354 363
Mean (Standard Deviation)
Unit of Measure: percent change in score
-69.49  (45.030) -66.75  (49.195)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.437
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
15.Secondary Outcome
Title Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
Hide Description Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 333 333
Mean (Standard Deviation)
Unit of Measure: percent change in score
20.53  (31.603) 19.71  (32.136)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.740
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
16.Secondary Outcome
Title Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
Hide Description Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.
Time Frame Week 0 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 327 321
Mean (Standard Deviation)
Unit of Measure: percent change in score
19.35  (30.264) 18.22  (29.967)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA.
17.Other Pre-specified Outcome
Title Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
Hide Description PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 321 319
Median (Inter-Quartile Range)
Unit of Measure: percent change in score
-100.00
(-100.0 to -87.5)
-100.00
(-100.0 to -80.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.74
Confidence Interval 95%
-5.30 to 24.78
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
Hide Description NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.
Time Frame Week 0 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description:
adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
adalimumab + calcipotriol/betamethasone ointment
Overall Number of Participants Analyzed 213 212
Median (Inter-Quartile Range)
Unit of Measure: percent change in score
-40.00
(-66.7 to 0.0)
-37.50
(-68.4 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab + Placebo, Adalimumab + Calcipotriol/Betamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method ANOVA
Comments One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.55
Confidence Interval 95%
-48.92 to 13.82
Estimation Comments [Not Specified]
Time Frame Overall study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Hide Arm/Group Description adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 adalimumab + calcipotriol/betamethasone ointment
All-Cause Mortality
Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   15/364 (4.12%)   16/366 (4.37%) 
Cardiac disorders     
angina pectoris  1  1/364 (0.27%)  0/366 (0.00%) 
Eye disorders     
retinal vein thrombosis  1  0/364 (0.00%)  1/366 (0.27%) 
vitreous haemorrhage  1  0/364 (0.00%)  1/366 (0.27%) 
General disorders     
oedema peripheral  1  0/364 (0.00%)  1/366 (0.27%) 
Hepatobiliary disorders     
hepatitis  1  0/364 (0.00%)  1/366 (0.27%) 
Immune system disorders     
anaphylatic shock  1  1/364 (0.27%)  0/366 (0.00%) 
Infections and infestations     
abortion infected  1  1/113 (0.88%)  0/116 (0.00%) 
bronchopneumonia  1  1/364 (0.27%)  0/366 (0.00%) 
erysipelas  1  1/364 (0.27%)  1/366 (0.27%) 
herpes zoster  1  0/364 (0.00%)  1/366 (0.27%) 
localised infection  1  0/364 (0.00%)  1/366 (0.27%) 
osteomyelitis  1  0/364 (0.00%)  1/366 (0.27%) 
pneumonia  1  0/364 (0.00%)  2/366 (0.55%) 
staphylococcal infection  1  1/364 (0.27%)  0/366 (0.00%) 
Investigations     
arteriogram coronary  1  0/364 (0.00%)  1/366 (0.27%) 
Musculoskeletal and connective tissue disorders     
joint swelling  1  0/364 (0.00%)  1/366 (0.27%) 
musculoskeletal pain  1  1/364 (0.27%)  0/366 (0.00%) 
pain in extremity  1  0/364 (0.00%)  1/366 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
lymphoma  1  1/364 (0.27%)  0/366 (0.00%) 
malignant melanoma  1  0/364 (0.00%)  1/366 (0.27%) 
rectal adenoma  1  0/364 (0.00%)  1/366 (0.27%) 
squamous cell carcinoma  1  0/364 (0.00%)  1/366 (0.27%) 
Nervous system disorders     
convulsion  1  1/364 (0.27%)  0/366 (0.00%) 
Skin and subcutaneous tissue disorders     
acute generalised exanthematous pustulosis  1  1/364 (0.27%)  0/366 (0.00%) 
dermatitis exfoliative  1  2/364 (0.55%)  0/366 (0.00%) 
dry skin  1  1/364 (0.27%)  0/366 (0.00%) 
onycholysis  1  0/364 (0.00%)  1/366 (0.27%) 
psoriasis  1  1/364 (0.27%)  1/366 (0.27%) 
skin inflammation  1  1/364 (0.27%)  0/366 (0.00%) 
Vascular disorders     
peripheral vascular disorder  1  0/364 (0.00%)  1/366 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Adalimumab + Placebo Adalimumab + Calcipotriol/Betamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   124/364 (34.07%)   136/366 (37.16%) 
Gastrointestinal disorders     
Diarrhoea  1  7/364 (1.92%)  11/366 (3.01%) 
Nausea  1  5/364 (1.37%)  12/366 (3.28%) 
General disorders     
Asthenia  1  2/364 (0.55%)  8/366 (2.19%) 
Fatigue  1  9/364 (2.47%)  8/366 (2.19%) 
Injection site pain  1  8/364 (2.20%)  3/366 (0.82%) 
Infections and infestations     
Influenza  1  8/364 (2.20%)  6/366 (1.64%) 
Nasopharyngitis  1  23/364 (6.32%)  32/366 (8.74%) 
Oral herpes  1  6/364 (1.65%)  9/366 (2.46%) 
Rhinitis  1  10/364 (2.75%)  4/366 (1.09%) 
Pharyngitis  1  12/364 (3.30%)  7/366 (1.91%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/364 (1.92%)  11/366 (3.01%) 
Nervous system disorders     
Headache  1  22/364 (6.04%)  19/366 (5.19%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  12/364 (3.30%)  11/366 (3.01%) 
Pharyngolaryngeal pain  1  8/364 (2.20%)  9/366 (2.46%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  21/364 (5.77%)  13/366 (3.55%) 
Psoriasis  1  17/364 (4.67%)  19/366 (5.19%) 
Vascular disorders     
Hypertension  1  4/364 (1.10%)  10/366 (2.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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.
Investigator shall provide Abbott at least (60) days prior to publication or presentation, for Abbott's review and comment, to ascertain whether any patent subject matter or Abbott confidential information are disclosed. During the review, Abbott may request a delay for up to six (6) months from the date of first submission to Abbott in order to protect proprietary information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Specialist
Organization: Abbott
Phone: 1-800-633-9110
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Responsible Party: Marie Rosenfeld, Senior CRM, Abbott
ClinicalTrials.gov Identifier: NCT00574249     History of Changes
Other Study ID Numbers: M10-060
First Submitted: December 12, 2007
First Posted: December 17, 2007
Results First Submitted: October 29, 2009
Results First Posted: January 18, 2010
Last Update Posted: April 13, 2011