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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00235820

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: adalimumab Drug: MTX Drug: placebo adalimumab, placebo MTX	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate Adalimumab BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: Every Study Visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Physician Global Assessment [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
PASI 50/90/100 [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]
DLQI [ Time Frame: Baseline - Week 16 ] [ Designated as safety issue: No ]

Enrollment:	271
Study Start Date:	July 2005
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: adalimumab 40 mg every other week following an 80 mg dose
B: Active Comparator	Drug: MTX MTX 7.5 to 25 mg once weekly
C: Placebo Comparator	Drug: placebo adalimumab, placebo MTX placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235820

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

Responsible Party:	Abbott ( Beverly Papierello/Director, Clinical Program Management )
Study ID Numbers:	M04-716
Study First Received:	October 7, 2005
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00235820
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Psoriasis
adalimumab

Study placed in the following topic categories:

Folic Acid
Skin Diseases
Psoriasis

Methotrexate
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009