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

Study Description

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

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: adalimumab; Drug: MTX; Drug: placebo adalimumab, placebo MTX	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 271 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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
• Study Start Date: July 2005
• Actual Primary Completion Date: May 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Physician Global Assessment [ Time Frame: Baseline - Week 16 ]
2. PASI 50/90/100 [ Time Frame: Baseline - Week 16 ]
3. DLQI [ Time Frame: Baseline - Week 16 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Beverly Papierello/Director, Clinical Program Management, Abbott
• ClinicalTrials.gov Identifier: NCT00235820
• Other Study ID Numbers: M04-716
• First Posted: October 12, 2005
• Last Update Posted: July 17, 2008
• Last Verified: June 2008

Keywords provided by Abbott:

Psoriasis; adalimumab

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents