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

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235820
• Other study ID #: M04-716
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: July 15, 2008
• Start date: July 2005

Study information

• Verified date: June 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• adalimumab
40 mg every other week following an 80 mg dose
• MTX
MTX 7.5 to 25 mg once weekly
• placebo adalimumab, placebo MTX
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)

Locations

Country	Name	City	State
United States	Global Medical Information-Abbott	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.		Week 16	No
Primary	Safety parameters		Every Study Visit	Yes
Secondary	Physician Global Assessment		Baseline - Week 16	No
Secondary	PASI 50/90/100		Baseline - Week 16	No
Secondary	DLQI		Baseline - Week 16	No