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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00235820
First received: October 7, 2005
Last updated: July 15, 2008
Last verified: June 2008
  Purpose

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
Psoriasis
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
  • adalimumab
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00235820

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

No publications provided

Responsible Party: Beverly Papierello/Director, Clinical Program Management, Abbott
ClinicalTrials.gov 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:
Psoriasis
adalimumab

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

ClinicalTrials.gov processed this record on September 30, 2014