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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00574249
Date of registration: 12/12/2007
Prospective Registration: Yes
Primary sponsor: Abbott
Public title: Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment BELIEVE
Scientific 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)
Date of first enrolment: November 2007
Target sample size: 730
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00574249
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Austria Belgium Czech Republic Denmark Finland France Germany Greece
Italy Netherlands Spain Sweden Switzerland Turkey United Kingdom United States
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Plaque Psoriasis
Intervention(s)
Biological: adalimumab
Drug: Calcipotriol/Betamethasone Ointment
Drug: placebo (vehicle ointment)
Primary Outcome(s)
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) [Time Frame: Week 0 and Week 16]
Secondary Outcome(s)
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 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 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 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]
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]
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 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 Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 [Time Frame: 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 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]
Secondary ID(s)
M10-060
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 18/01/2010
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00574249
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