CHAMPION: Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Details
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A
|
Drug: adalimumab
40 mg every other week following an 80 mg dose
Other Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. [Week 16]
- Safety parameters [Every Study Visit]
Secondary Outcome Measures
- Physician Global Assessment [Baseline - Week 16]
- PASI 50/90/100 [Baseline - Week 16]
- DLQI [Baseline - Week 16]
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Global Medical Information-Abbott | Abbott Park | Illinois | United States | 60064 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Global Medical Information, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M04-716