Back to resultsAdalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adalimumab
Calcipotriol/Betamethasone Ointment
placebo (vehicle ointment)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Psoriasis, Moderate Psoriasis, Severe Psoriasis, Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subject is >= 18 years of age
- Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
- Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
- Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria:
- Subject has previous exposure to adalimumab
- Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- Subject is taking or requires oral or injectible corticosteroids
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
- Subject has a calcium metabolism disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
adalimumab + placebo
adalimumab + calcipotriol/betamethasone
Arm Description
adalimumab + placebo (vehicle ointment)
adalimumab + calcipotriol/betamethasone ointment
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
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.
Secondary Outcome Measures
Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
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.
Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
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.
Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
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.
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
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).
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
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).
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
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).
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
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).
Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
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).
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
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%.
Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
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%.
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
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%.
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
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%.
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
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%.
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
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%.
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00574249
Brief Title
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Acronym
BELIEVE
Official Title
A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.
Detailed Description
Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Psoriasis, Moderate Psoriasis, Severe Psoriasis, Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adalimumab + placebo
Arm Type
Active Comparator
Arm Description
adalimumab + placebo (vehicle ointment)
Arm Title
adalimumab + calcipotriol/betamethasone
Arm Type
Active Comparator
Arm Description
adalimumab + calcipotriol/betamethasone ointment
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
Intervention Type
Drug
Intervention Name(s)
Calcipotriol/Betamethasone Ointment
Other Intervention Name(s)
Daivobet
Intervention Description
Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/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
Intervention Type
Drug
Intervention Name(s)
placebo (vehicle ointment)
Intervention Description
Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) 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
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
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
Title
Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
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
Title
Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
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
Title
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
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
Title
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
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
Title
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
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
Title
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
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
Title
Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
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
Title
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
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
Title
Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
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
Title
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
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
Title
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
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
Title
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
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
Title
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
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
Title
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
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
Other Pre-specified Outcome Measures:
Title
Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
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
Title
Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is >= 18 years of age
Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria:
Subject has previous exposure to adalimumab
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Subject is taking or requires oral or injectible corticosteroids
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Subject has a calcium metabolism disorder
Facility Information:
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wein
ZIP/Postal Code
1160
Country
Austria
City
Wien
ZIP/Postal Code
1030
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Geel
ZIP/Postal Code
2440
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Mons
ZIP/Postal Code
7000
Country
Belgium
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Prague
ZIP/Postal Code
11000
Country
Czech Republic
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
City
Herning
ZIP/Postal Code
7400
Country
Denmark
City
Helsinki HUS
ZIP/Postal Code
00029
Country
Finland
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
City
Lahti
ZIP/Postal Code
15850
Country
Finland
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
City
Nancy
ZIP/Postal Code
54000
Country
France
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Pierre Benite Cedex
ZIP/Postal Code
69310
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
St Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
10827
Country
Germany
City
Buchholz Nordheide
ZIP/Postal Code
21244
Country
Germany
City
Dresden
ZIP/Postal Code
01067
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
City
Halle Saale
ZIP/Postal Code
06097
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
City
Hannover
ZIP/Postal Code
30449
Country
Germany
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
City
Jena
ZIP/Postal Code
07740
Country
Germany
City
Kiel
ZIP/Postal Code
24150
Country
Germany
City
Koln
ZIP/Postal Code
50924
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Munchen
ZIP/Postal Code
80337
Country
Germany
City
Munster
ZIP/Postal Code
48149
Country
Germany
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
City
Osnabruck
ZIP/Postal Code
49078
Country
Germany
City
Potsdam
ZIP/Postal Code
14480
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Rostock
ZIP/Postal Code
18055
Country
Germany
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
City
Athens
ZIP/Postal Code
16121
Country
Greece
City
Crete
ZIP/Postal Code
71201
Country
Greece
City
Benevento
ZIP/Postal Code
82100
Country
Italy
City
Catania
ZIP/Postal Code
95124
Country
Italy
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
City
Coppitto-L'Aquila
ZIP/Postal Code
67100
Country
Italy
City
Firenze
ZIP/Postal Code
50119
Country
Italy
City
Messina
ZIP/Postal Code
98200
Country
Italy
City
Milano
ZIP/Postal Code
20161
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Roma
ZIP/Postal Code
0133
Country
Italy
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GL
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 CA
Country
Netherlands
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
City
Bilbao
ZIP/Postal Code
48903
Country
Spain
City
Galdacano Vizcaya
ZIP/Postal Code
48960
Country
Spain
City
Granada
ZIP/Postal Code
18012
Country
Spain
City
Las Palmas de Gran Canarias
ZIP/Postal Code
35010
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Malaga
ZIP/Postal Code
29071
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
City
Santiago
ZIP/Postal Code
15700
Country
Spain
City
Seville
ZIP/Postal Code
41009
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Vigo
ZIP/Postal Code
36024
Country
Spain
City
Falun
ZIP/Postal Code
79182
Country
Sweden
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Bursa
ZIP/Postal Code
16045
Country
Turkey
City
Capa
ZIP/Postal Code
34390
Country
Turkey
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
City
Aberdeen
ZIP/Postal Code
AB25 2ZR
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Newport Gwent
ZIP/Postal Code
NP20 4SZ
Country
United Kingdom
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23178916
Citation
Paul C, van de Kerkhof P, Puig L, Unnebrink K, Goldblum O, Thaci D. Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. Eur J Dermatol. 2012 Nov-Dec;22(6):762-9. doi: 10.1684/ejd.2012.1863.
Results Reference
derived
Learn more about this trial
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
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