Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: adalimumab
* Drug: MTX
* Drug: placebo adalimumab, placebo MTX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents. Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections. Male subjects must hve been vasectomized or practicing birth control. Exclusion Criteria: Previous systemic anti-TNF therapy. Prior use of MTX. Known hypersensitivity to the constituents of adalimumab. Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment. Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline. Use of PUVA for at least 4 weeks prior to Baseline. Use of oral or injectable corticosteroids during the study. Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study. Female subject who is pregnant or breast feeding or considering becoming pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: adalimumab<br>* 40 mg every other week following an 80 mg dose<br>* Other names: Humira;|
| Active Comparator: B<br> | Drug: MTX<br>* MTX 7.5 to 25 mg once weekly<br>|
| Placebo Comparator: C<br> | Drug: placebo adalimumab, placebo MTX<br>* placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. |  | Week 16 | 
| Safety parameters |  | Every Study Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment |  | Baseline - Week 16 | 
| PASI 50/90/100 |  | Baseline - Week 16 | 
| DLQI |  | Baseline - Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, adalimumab