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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01251614
First received: December 1, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Biological: Adalimumab - Low Dose
Biological: Adalimumab - Standard Dose
Drug: Methotrexate
Biological: Adalimumab - Open-Label
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    The proportion of subjects achieving a PASI 75 response, standard dose versus MTX.

  • Physician's Global Assessment of Disease Activity (PGA) 0, 1 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    The proportion of subjects achieving a PGA 0, 1 standard dose versus MTX.

  • Adverse Events [ Time Frame: At every visit from Baseline (Week 0) to final Visit (Week 156) ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence


Secondary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) 90 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    The proportion of subjects achieving a PASI 90, standard dose versus MTX

  • Psoriasis Area and Severity Index (PASI) 100 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    The proportion of subjects achieving a PASI 90, standard dose versus MTX

  • Children's Dermatology Life Quality Index [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    Change from baseline in the Paediatric Quality of Life Inventory (PedsQL), standard dose versus MTX

  • Physician's Global Assessment of Disease Activity 0,1 [ Time Frame: Week 16, Period A ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time from entry into Period B until loss of disease control ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 111
Study Start Date: December 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab - Low Dose Biological: Adalimumab - Low Dose
0.4 mg/kg up to a maximum of 20mg every other week
Other Name: ABT-D2E7 Humira
Experimental: Adalimumab - Standard Dose Biological: Adalimumab - Standard Dose
0.8 mg/kg up to a maximum of 40mg every other week
Other Name: ABT-D2E7 Humira
Active Comparator: Methotrexate Drug: Methotrexate
0.4mg/kg/week up to a maximum of 25 mg per week
Experimental: Adalimumab Open-Label Biological: Adalimumab - Open-Label
0.4 mg/kg up to a maximum of 20 mg every other week or 0.8 mg/kg up to a maximum of 40mg every other week starting at Week 0 in Open-Label Period
Other Name: ABT-D2E7 Humira

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251614

  Show 41 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: David A Williams, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01251614     History of Changes
Other Study ID Numbers: M04-717, 2009-013072-52
Study First Received: December 1, 2010
Last Updated: July 21, 2014
Health Authority: Canada: Health Canada
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health

Keywords provided by AbbVie:
Randomized
Double-blind
Chronic plaque psoriasis
Pediatric

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 15, 2014