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) - ND

• Conditions: chronic plaque psoriasis; MedDRA version: 13.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2009-013072-52-IT
• Lead Sponsor: Abbott GmBH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 16 November 2015

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 appropriate traditional therapy (topical, phototherapy and/or heliotherapy, as applicable by age and country of residence); 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. Subject must have a clinical diagnosis of psoriasis for at least 6 months ; 6. 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. Prior therapy with etanercept within 4 weeks of Baseline 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 ; 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