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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: adalimumab (Drug); MTX (Drug); placebo adalimumab, placebo MTX (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

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

Primary outcome:

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

Safety parameters

Secondary outcome:

Physician Global Assessment

PASI 50/90/100

DLQI

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Global Medical Information-Abbott, Abbott Park, Illinois 60064, United States
Additional Information

Starting date: July 2005
Last updated: July 15, 2008

Page last updated: August 23, 2015

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