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”

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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
  • Active Loading Dose at Baseline - 80 mg Active Maintenance dose - 40 mg EOW
• Biological: Calcipotriol + Betamethasone
  • Calcipotriol + Betamethasone (50%) - No more than 100grams per week OR Placebo Calcipotriol + Betamethasone (50%) - No more than 100grams per week

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• PASI 75
  • Time Frame: Week 16
    Safety Issue?: No

Secondary Measures

• Safety parameters
  • Time Frame: Throughout study
    Safety Issue?: No
• PGA
  • Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at weeks 2, 4, 8, 12 and 16
    Safety Issue?: No
• DLQI
  • Time Frame: Change from Baseline in DLQI total score at weeks 2, 4, 8, 12 and 16
    Safety Issue?: No
• PASI
  • Time Frame: Subjects who achieve PASI 50, 90 and 100
    Safety Issue?: No
• SF-36
  • Time Frame: Weeks 8 and 16
    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

Overall Clinical Trial Officials and Contacts

Hartmutt Kupper, MD Study Director Abbott  

Information obtained from ClinicalTrials.gov on September 05, 2008

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