EUCTR2009-013072-52-BE进行中（未招募）1 期
A Multicentre, Randomised, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plaque Psoriasis (Ps)
AbbVie DeutschlandGmbH & Co. KG0 个研究点目标入组 114 人开始时间: 2010年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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:
- •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
排除标准
- •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;
研究者
相似试验
进行中（未招募）
不适用
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.Chronic Plaque PsoriasisMedDRA version: 16.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2009-013072-52-DEAbbVie Deutschland GmbH & Co. KG111
进行中（未招募）
不适用
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.Chronic Plaque PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2009-013072-52-NLAbbott GmbH & Co. KG111
进行中（未招募）
不适用
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.EUCTR2009-013072-52-Outside-EU/EEAAbbott GmbH & Co. KG111
已完成
3 期
A Multicentre, Randomised, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plaque Psoriasis (Ps)10014982NL-OMON37563AbbVie B.V.10
进行中（未招募）
不适用
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.Chronic Plaque PsoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2009-013072-52-CZAbbVie Deutschland GmbH & Co. KG111