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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
adalimumab
MTX
placebo adalimumab, placebo MTX
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, adalimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Global Medical Information-Abbott

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Safety parameters

Secondary Outcome Measures

Physician Global Assessment
PASI 50/90/100
DLQI

Full Information

First Posted
October 7, 2005
Last Updated
July 15, 2008
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00235820
Brief Title
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
CHAMPION
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, adalimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg every other week following an 80 mg dose
Intervention Type
Drug
Intervention Name(s)
MTX
Intervention Description
MTX 7.5 to 25 mg once weekly
Intervention Type
Drug
Intervention Name(s)
placebo adalimumab, placebo MTX
Other Intervention Name(s)
placebo
Intervention Description
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
Primary Outcome Measure Information:
Title
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Time Frame
Week 16
Title
Safety parameters
Time Frame
Every Study Visit
Secondary Outcome Measure Information:
Title
Physician Global Assessment
Time Frame
Baseline - Week 16
Title
PASI 50/90/100
Time Frame
Baseline - Week 16
Title
DLQI
Time Frame
Baseline - Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information-Abbott
City
Abbott Park
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26547918
Citation
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.
Results Reference
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Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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