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

NCT ID: NCT00235820

Last Updated: 2008-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Keywords

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Psoriasis adalimumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

adalimumab

Intervention Type DRUG

40 mg every other week following an 80 mg dose

B

Group Type ACTIVE_COMPARATOR

MTX

Intervention Type DRUG

MTX 7.5 to 25 mg once weekly

C

Group Type PLACEBO_COMPARATOR

placebo adalimumab, placebo MTX

Intervention Type DRUG

placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)

Interventions

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adalimumab

40 mg every other week following an 80 mg dose

Intervention Type DRUG

MTX

MTX 7.5 to 25 mg once weekly

Intervention Type DRUG

placebo adalimumab, placebo MTX

placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)

Intervention Type DRUG

Other Intervention Names

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ABT-D2E7 Humira placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information-Abbott

Abbott Park, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26547918 (View on PubMed)

Other Identifiers

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M04-716

Identifier Type: -

Identifier Source: org_study_id