Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

Abbott

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: placebo (vehicle ointment); Biological: adalimumab; Drug: Calcipotriol/Betamethasone Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00574249

M10-060

Details and patient eligibility

About

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.

Full description

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

Enrollment: 730 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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730 participants in 2 patient groups

adalimumab + placebo

Active Comparator group

Description:

adalimumab + placebo (vehicle ointment)

Treatment:

Biological: adalimumab

Drug: placebo (vehicle ointment)

adalimumab + calcipotriol/betamethasone

Active Comparator group

Description:

adalimumab + calcipotriol/betamethasone ointment

Treatment:

Drug: Calcipotriol/Betamethasone Ointment

Biological: adalimumab