Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00235820
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : July 17, 2008
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date July 17, 2008
Study Start Date  ICMJE July 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
  • Physician Global Assessment [ Time Frame: Baseline - Week 16 ]
  • PASI 50/90/100 [ Time Frame: Baseline - Week 16 ]
  • DLQI [ Time Frame: Baseline - Week 16 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Safety parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title  ICMJE 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
Brief Summary Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: adalimumab
    40 mg every other week following an 80 mg dose
    Other Names:
    • ABT-D2E7
    • Humira
  • Drug: MTX
    MTX 7.5 to 25 mg once weekly
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: adalimumab
  • Active Comparator: B
    Intervention: Drug: MTX
  • Placebo Comparator: C
    Intervention: Drug: placebo adalimumab, placebo MTX
Publications * Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2008)
271
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
250
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00235820
Other Study ID Numbers  ICMJE M04-716
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beverly Papierello/Director, Clinical Program Management, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Medical Information Abbott
PRS Account Abbott
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP