Clinical trial NCT00235820: Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
adalimumab
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
timeFrame: Week 16
measure: Safety parameters
timeFrame: Every Study Visit
Secondary outcomes:
measure: Physician Global Assessment
timeFrame: Baseline - Week 16
measure: PASI 50/90/100
timeFrame: Baseline - Week 16
measure: DLQI
timeFrame: Baseline - Week 16
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information-Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
citation: Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.