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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Every Study Visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physician Global Assessment [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
  • PASI 50/90/100 [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
  • DLQI [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Papulosquamous
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 26, 2016