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A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: Adalimumab - Low Dose (Biological); Adalimumab - Standard Dose (Biological); Methotrexate (Drug); Adalimumab - Open-Label (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
David A Williams, MD, Study Director, Affiliation: AbbVie

Summary

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Psoriasis Area and Severity Index (PASI) 75

Physician's Global Assessment of Disease Activity (PGA) 0, 1

Adverse Events

Secondary outcome:

Psoriasis Area and Severity Index (PASI) 90

Psoriasis Area and Severity Index (PASI) 100

Children's Dermatology Life Quality Index

Change from baseline in the Paediatric Quality of Life Inventory

Physician's Global Assessment of Disease Activity 0,1

Time to Loss of Disease Control

Eligibility

Minimum age: 4 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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:

- Physician's Global Assessment (PGA) ≥ 4

- Body surface area (BSA) involved > 20%

- Very thick lesions with BSA > 10% - Psoriasis Area and Severity Index (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

- Children's Dermatology Life Quality Index (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 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. Methotrexate (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;

Locations and Contacts

Site Reference ID/Investigator# 23114, Brussels 1200, Belgium

Site Reference ID/Investigator# 43256, Ghent 9000, Belgium

Site Reference ID/Investigator# 23115, Mons 7000, Belgium

Site Reference ID/Investigator# 23120, Calgary T2G 1B1, Canada

Site Reference ID/Investigator# 23119, Markham L3P 1A8, Canada

Site Reference ID/Investigator# 44718, Montreal H3T 1C5, Canada

Site Reference ID/Investigator# 42702, Quebec G1J 1X7, Canada

Site Reference ID/Investigator# 46608, Saskatoon S7N 0W8, Canada

Site Reference ID/Investigator# 23117, St. John's A1A 5E8, Canada

Site Reference ID/Investigator# 42703, Vancouver V6H 3V4, Canada

Site Reference ID/Investigator# 43239, Waterloo N2J 1C4, Canada

Site Reference ID/Investigator# 43238, Winnipeg R3C 0N2, Canada

Site Reference ID/Investigator# 69705, Recoleta, Chile

Site Reference ID/Investigator# 69704, Vitacura, Chile

Site Reference ID/Investigator# 45002, Brno 62500, Czech Republic

Site Reference ID/Investigator# 45003, Prague 2 121 00, Czech Republic

Site Reference ID/Investigator# 66803, Usti nad Labem 40113, Czech Republic

Site Reference ID/Investigator# 43985, Berlin 10117, Germany

Site Reference ID/Investigator# 43984, Dresden 01307, Germany

Site Reference ID/Investigator# 23143, Frankfurt am Main 60590, Germany

Site Reference ID/Investigator# 42642, Hamburg 22149, Germany

Site Reference ID/Investigator# 45442, Mainz 55131, Germany

Site Reference ID/Investigator# 42625, Budapest 1089, Hungary

Site Reference ID/Investigator# 42623, Szeged 6720, Hungary

Site Reference ID/Investigator# 44583, Padova 35128, Italy

Site Reference ID/Investigator# 43043, Mexico, D.F. C.P. 06720, Mexico

Site Reference ID/Investigator# 43045, Monterrey, N.L. C.P. 64460, Mexico

Site Reference ID/Investigator# 43046, Zapopan Jalisco C.P. 45190, Mexico

Site Reference ID/Investigator# 69685, Nijmegen 6525 GL, Netherlands

Site Reference ID/Investigator# 43862, Lodz 90-265, Poland

Site Reference ID/Investigator# 44782, Wroclaw 50-368, Poland

Site Reference ID/Investigator# 46422, Alicante 03010, Spain

Site Reference ID/Investigator# 44749, Barcelona 08950, Spain

Site Reference ID/Investigator# 44748, Madrid 28046, Spain

Site Reference ID/Investigator# 45490, Madrid 28009, Spain

Site Reference ID/Investigator# 67564, Sevilla 41013, Spain

Site Reference ID/Investigator# 44857, Zurich 8032, Switzerland

Site Reference ID/Investigator# 43765, Ankara 06100, Turkey

Site Reference ID/Investigator# 44585, Ankara 06018, Turkey

Site Reference ID/Investigator# 44502, Gorukle Bursa 16048, Turkey

Site Reference ID/Investigator# 43763, Istanbul 34390, Turkey

Additional Information

Starting date: December 2010
Last updated: December 19, 2014

Page last updated: August 23, 2015

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