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Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis (CHAMPION)

This study has been completed.
Information provided by:
Abbott Identifier:
First received: October 7, 2005
Last updated: July 15, 2008
Last verified: June 2008
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition Intervention Phase
Drug: adalimumab
Drug: MTX
Drug: placebo adalimumab, placebo MTX
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. [ Time Frame: Week 16 ]
  • Safety parameters [ Time Frame: Every Study Visit ]

Secondary Outcome Measures:
  • Physician Global Assessment [ Time Frame: Baseline - Week 16 ]
  • PASI 50/90/100 [ Time Frame: Baseline - Week 16 ]
  • DLQI [ Time Frame: Baseline - Week 16 ]

Enrollment: 271
Study Start Date: July 2005
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg every other week following an 80 mg dose
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: B Drug: MTX
MTX 7.5 to 25 mg once weekly
Placebo Comparator: C Drug: placebo adalimumab, placebo MTX
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
Other Name: placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
  • Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
  • Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
  • Male subjects must hve been vasectomized or practicing birth control.

Exclusion Criteria:

  • Previous systemic anti-TNF therapy.
  • Prior use of MTX.
  • Known hypersensitivity to the constituents of adalimumab.
  • Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
  • Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
  • Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
  • Use of PUVA for at least 4 weeks prior to Baseline.
  • Use of oral or injectable corticosteroids during the study.
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Female subject who is pregnant or breast feeding or considering becoming pregnant.
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Please refer to this study by its identifier: NCT00235820

United States, Illinois
Global Medical Information-Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Study Director: Global Medical Information Abbott
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Beverly Papierello/Director, Clinical Program Management, Abbott Identifier: NCT00235820     History of Changes
Other Study ID Numbers: M04-716
Study First Received: October 7, 2005
Last Updated: July 15, 2008

Keywords provided by Abbott:

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
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 processed this record on April 26, 2017