Chronic Plaque PsoriasisPhase 3BELIEVENCT00574249
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
A Phase 3 study testing adalimumab and Calcipotriol/Betamethasone Ointment in people with Chronic Plaque Psoriasis, run by Abbott at 131 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- adalimumab and Calcipotriol/Betamethasone Ointment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 730 participants
- Where
- 131 sitesin 15 countries
- Study dates
- Nov 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
131 sites in 15 countries.
131 sites in 15 countries
Germany29 sites
Study site
Berlin, 10117
Study site
Berlin, 10827
Study site
Buchholz Nordheide, 21244
Study site
Cologne, 50924
Study site
Dresden, 01067
Study site
Dresden, 01307
Study site
Düsseldorf, 40225
Study site
Erlangen, 91052
Study site
Frankfurt, 60590
Study site
Freiburg im Breisgau, 79104
Study site
Göttingen, 37075
Study site
Halle, 06097
Study site
Hamburg, 20246
Study site
Hamburg, 20354
Study site
Hanover, 30449
Study site
Heidelberg, 69115
Study site
Jena, 07740
Study site
Kiel, 24150
Study site
Leipzig, 04103
Study site
Magdeburg, 39120
Study site
Mainz, 55101
Study site
München, 80337
Study site
Münster, 48149
Study site
Oldenburg, 26133
Study site
Osnabrück, 49078
Study site
Potsdam, 14480
Study site
Regensburg, 93053
Study site
Rostock, 18055
Study site
Tübingen, 72076
Spain21 sites
Study site
Alicante, 03010
Study site
Barcelona, 08025
Study site
Barcelona, 08036
Study site
Barcelona, 08916
Study site
Bilbao, 48013
Study site
Bilbao, 48903
Study site
Galdacano Vizcaya, 48960
Study site
Granada, 18012
Study site
Las Palmas de Gran Canarias, 35010
Study site
Madrid, 28006
Study site
Madrid, 28034
Study site
Madrid, 28041
Study site
Madrid, 28046
Study site
Málaga, 29071
Study site
Santander, 39008
Study site
Santiago, 15700
Study site
Santiago de Compostela, 15706
Study site
Seville, 41009
Study site
Valencia, 46009
Study site
Valencia, 46014
Study site
Vigo, 36024
France13 sites
Study site
Brest, 29609
Study site
Créteil, 94010
Study site
Lille, 59037
Study site
Limoges, 87042
Study site
Montpellier, 34295
Study site
Nancy, 54000
Study site
Nice, 06202
Study site
Paris, 75475
Study site
Pessac, 33604
Study site
Pierre-Bénite, 69310
Study site
Rouen, 76031
Study site
Saint-Etienne, 42055
Study site
Toulouse, 31059
Belgium12 sites
Study site
Aalst, 9300
Study site
Bruges, 8000
Study site
Brussels, 1070
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Edegem, 2650
Study site
Geel, 2440
Study site
Ghent, 9000
Study site
Kortrijk, 8500
Study site
Leuven, 3000
Study site
Liège, 4000
Study site
Mons, 7000
Italy11 sites
Study site
Benevento, 82100
Study site
Catania, 95124
Study site
Catanzaro, 88100
Study site
Coppitto-L'Aquila, 67100
Study site
Florence, 50119
Study site
Messina, 98200
Study site
Milan, 20161
Study site
Modena, 41100
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Roma, 0133
United Kingdom8 sites
Study site
Aberdeen, AB25 2ZR
Study site
Cardiff, CF14 4XN
Study site
Glasgow, G11 6NT
Study site
Leeds, LS1 3EX
Study site
London, NW3 2QG
Study site
Manchester, M6 8HD
Study site
Newport Gwent, NP20 4SZ
Study site
Nuneaton, CV10 7DJ
Austria6 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Salzburg, 5020
Study site
Vienna, 1030
Study site
Vienna, 1090
Study site
Wein, 1160
Turkey (Türkiye)6 sites
Study site
Ankara, 06100
Study site
Ankara, 06500
Study site
Bursa, 16045
Study site
Çapa, 34390
Study site
Istanbul, 34098
Study site
Istanbul, 34668
Netherlands5 sites
Study site
Amsterdam, 1105 AZ
Study site
Breda, 4818 CK
Study site
Maastricht, 6229 HX
Study site
Nijmegen, 6525 GL
Study site
Rotterdam, 3015 CA
Denmark4 sites
Study site
Arhus C, 8000
Study site
Copenhagen, 2400
Study site
Hellerup, 2900
Study site
Herning, 7400
Sweden4 sites
Study site
Falun, 79182
Study site
Gothenburg, 41345
Study site
Malmö, 20502
Study site
Stockholm, 17176
Switzerland4 sites
Study site
Basel, 4031
Study site
Bern, 3010
Study site
Geneva, 1211
Study site
Zurich, 8091
Czechia3 sites
Study site
Brno, 65691
Study site
Hradec Králové, 500 05
Study site
Prague, 11000
Finland3 sites
Study site
Helsinki HUS, 00029
Study site
Jyväskylä, 40620
Study site
Lahti, 15850
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- adalimumab, Calcipotriol/Betamethasone Ointment, placebo (vehicle ointment)
- Keywords
- Psoriasis, Moderate Psoriasis, Severe Psoriasis, Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, Humira
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
Calcipotriol/Betamethasone OintmentDrug
Also called Daivobet
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
placebo (vehicle ointment)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| adalimumab + placebo | Active comparator | adalimumab + placebo (vehicle ointment) Receives: Biological: adalimumab; Drug: placebo (vehicle ointment) |
| adalimumab + calcipotriol/betamethasone | Active comparator | adalimumab + calcipotriol/betamethasone ointment Receives: Biological: adalimumab; Drug: Calcipotriol/Betamethasone Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and Week 16
Secondary outcomes (15)
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.
Measured: Week 0 and Week 16
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.
Measured: Week 0 and Week 16
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.
Measured: Week 0 and Week 16
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).
Measured: Week 2
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).
Measured: Week 4
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).
Measured: Week 8
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).
Measured: Week 12
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).
Measured: Week 16
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%.
Measured: Week 0 and Week 16
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%.
Measured: Week 0 and Week 2
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%.
Measured: Week 0 and Week 4
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%.
Measured: Week 0 and Week 8
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%.
Measured: Week 0 and Week 12
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%.
Measured: Week 0 and Week 16
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%.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574249
- Sponsor's protocol ID
- M10-060
- Acronym
- BELIEVE
- Status last verified
- Apr 2011
- First submitted
- 12 Dec 2007
- Last updated
- 13 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23178916
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00574249
- Acronym / sponsor ID
- BELIEVE / M10-060
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Psoriasis, Moderate Psoriasis, Severe Psoriasis, Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 18 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adalimumab + placebo | Active comparator | Biological: adalimumab, Drug: placebo (vehicle ointment)adalimumab + placebo (vehicle ointment) |
| adalimumab + calcipotriol/betamethasone | Active comparator | Biological: adalimumab, Drug: Calcipotriol/Betamethasone Ointmentadalimumab + calcipotriol/betamethasone ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humirasubcutaneous 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 | Biological | adalimumab + calcipotriol/betamethasone, adalimumab + placebo |
| Calcipotriol/Betamethasone OintmentAlso: DaivobetTopical 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 | Drug | adalimumab + calcipotriol/betamethasone |
| placebo (vehicle ointment)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 | Drug | adalimumab + placebo |
Primary outcome
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
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.
15 secondary outcomes
Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
Time frame: Week 2
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
Time frame: Week 4
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
Time frame: Week 8
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
Time frame: Week 12
Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
Time frame: Week 16
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 2
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 4
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 8
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 12
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 16
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
Time frame: Week 0 and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23178916Paul 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.
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RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
131 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab and Calcipotriol/Betamethasone Ointment in people with Chronic Plaque Psoriasis, run by Abbott at 131 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 131 sites in Germany, Spain, France, Belgium, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (time frame: Week 0 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00574249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.