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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: October 2008

Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.

Intervention(s) in this Clinical Trial

• Biological: adalimumab
  • 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
• Drug: Calcipotriol/Betamethasone Ointment
  • 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
• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: adalimumab + placebo
  • adalimumab + placebo (vehicle ointment)
• Active Comparator: adalimumab + calcipotriol/betamethasone
  • adalimumab + calcipotriol/betamethasone ointment

Primary Measures

• Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
  • Time Frame: Week 0 and Week 16
    Safety Issue?: No

Secondary Measures

• Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
  • Time Frame: Week 0 and Week 16
    Safety Issue?: No
• Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
  • Time Frame: Week 0 and Week 16
    Safety Issue?: No
• Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
  • Time Frame: Week 0 and Week 16
    Safety Issue?: No
• Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
  • Time Frame: Week 2
    Safety Issue?: No
• Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
  • Time Frame: Week 4
    Safety Issue?: No
• Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
  • Time Frame: Week 8
    Safety Issue?: No
• Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
  • Time Frame: Week 16
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574249

Study ID Number: M10-060

ClinicalTrials.gov Identifier: NCT00574249

Health Authority: Turkey: Ethics Committee