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

• ClinicalTrials.gov Identifier: NCT00235820
• Recruitment Status: Completed
• First Posted: October 12, 2005
• Last Update Posted: July 17, 2008
• Sponsor: Abbott
• Information provided by: Abbott

Tracking Information

• First Submitted Date: October 7, 2005
• First Posted Date: October 12, 2005
• Last Update Posted Date: July 17, 2008
• Study Start Date: July 2005
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 7, 2005): Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.

Current Secondary Outcome Measures (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 (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: Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 15, 2008): 271
• Original Enrollment (submitted: October 7, 2005): 250
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00235820
• Other Study ID Numbers: M04-716
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Beverly Papierello/Director, Clinical Program Management, Abbott
• Study Sponsor: Abbott
• Collaborators: Not Provided

Investigators

• Study Director: Global Medical Information; Abbott

• PRS Account: Abbott
• Verification Date: June 2008