This study will compare how well adalimumab works versus methotrexate (MTX) in children with moderate to severe psoriasis in the short term. It will also study how safe and how well adalimumab works in the long term and how long disease response can be maintained after stopping therapy.

Conditions: Chronic Plaque Psoriasis
MedDRA version: 16.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2009-013072-52-DE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

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:
• Active psoriatic arthritis unresponsive to non-steroid anti-inflammatory drugs (NSAIDs)
• Clinically relevant facial involvement
• Clinically relevant genital involvement
• Clinically relevant hand and/or foot involvement
• 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. Treatment with etanercept therapy within 4 weeks prior to the Baseline visit;
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. Treatment of Ps with topical therapies such as corticosteroids, vitamin D analogs, or retinoids within 7 days prior to the Baseline visit;
8. Treatment of Ps with UVB phototherapy, excessive sun exposure, or the use of tanning beds within 7 days prior to the Baseline visit;
9. Treatment of Ps with PUVA phototherapy, non-biologic systemic therapies for the treatment of Ps, or systemic therapies known to improve Ps within 14 days prior to the Baseline visit;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety and efficacy of two doses of adalimumab versus methotrexate in pediatric subjects with chronic plaque psoriasis.;Secondary Objective: To determine the time to loss of disease control and the ability to regain response upon retreatment, and to examine the pharmacokinetics and immunogenicity of adalimumab following subcutaneous administration in this subject population.;Primary end point(s): The proportion of subjects achieving a >= PASI 75 response standard dose versus MTX.<br><br>;Timepoint(s) of evaluation of this end point: Week 16, Period A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The proportion of subjects achieving a PASI 90, standard dose versus MTX; The proportion of subjects achieving a PASI 90, standard dose versus MTX;Change from baseline in the Children's Dermatology Life Quality Index (CDLQI) scores, standard dose versus MTX; Change from baseline in the Paediatric Quality of Life Inventory (PedsQL), standard dose versus MTX;The proportion of subjects achieving PGA 0, 1 upon completion of retreatment (Period C) according to the original randomised group assignment in Period A (standard dose adalimumab versus low dose adalimumab);Time to loss of disease control (Period B) according to the original randomised group assignment in Period A (standard dose adalimumab versus low dose adalimumab and MTX).;Timepoint(s) of evaluation of this end point: Week 16, Period A

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