A Multi-centre, Randomised, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plaque Psoriasis (Ps)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 111

Inclusion Criteria

1. Subject is = 4 years and < 18 years of age;
2. Subject weighs = 13 kg;
3. Subject must have failed to respond to topical therapy;
4. Subject must need systemic treatment to control his/her disease and meet one of the following:
• PGA = 4
• Body surface area (BSA) involved > 20%
• Very thick lesions with BSA > 10%
• PASI > 20
• PASI > 10 and at least one of the following:
o Active psoriatic arthritis unresponsive to NSAIDs
o Clinically relevant facial involvement
o Clinically relevant genital involvement
o Clinically relevant hand and/or foot involvement
o CDLQI > 10
5. If subject is < 12 years of age and resides in a geographic region where heliotherapy is practical, subject must have failed to respond, be intolerant, or have a contraindication to heliotherapy, or is not a suitable candidate for heliotherapy;
6. If =12 years of age, subject must have failed to respond, be intolerant, or have a contraindication to phototherapy, or is not a suitable candidate for phototherapy;
7. Subject must have a clinical diagnosis of psoriasis for at least 6 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator;
8. Subject must have stable plaque psoriasis for at least 2 months prior to Baseline;
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior biologic use other than prior treatment with etanercept;
2. Subject cannot avoid etanercept therapy for at least 4 weeks prior to the Baseline visit and during the study;
3. MTX use within the past year or prior MTX use at any time where the subject did not respond, or did not tolerate MTX;
4. Contraindication for treatment with MTX during the study;
5. Erythrodermic Ps, generalized or localized pustular Ps, medication-induced or medication exacerbated Ps or new onset guttate Ps;
6. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit;
7. Subject cannot discontinue topical therapies for the treatment of Ps such as corticosteroids, vitamin D analogs, or retinoids at least 1 week prior to the Baseline visit;
8. Subject cannot avoid UVB phototherapy, excessive sun exposure, or the use of tanning beds for at least 1 week prior to the Baseline visit and during the study;
9. Subject cannot avoid PUVA phototherapy, non-biologic systemic therapies for the treatment of Ps, or systemic therapies known to improve Ps for at least 2 weeks prior to the Baseline visit and during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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