Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life

NCT ID: NCT01169987

Last Updated: 2016-07-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-03-31

Brief Summary

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This observational study will document to what extent in daily clinical practice Humira (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and reasons for restarting Humira therapy will be noted. An evaluation will be performed of the effect of the disease on quality of life and work productivity.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Treated with Adalimumab

Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment is initiated. All medications will be prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients \> or = 18 years
* Patient with chronic plaque psoriasis
* Patient newly initiated on Humira
* Patient compliant with Humira Summary of Product Characteristics
* Patient compliant with Belgian reimbursement criteria of Humira in plaque psoriasis
* Patient has signed informed consent

Exclusion Criteria

* Patients having any of the contraindications mentioned in the Summary of Product Characteristics Humira
* Patients not willing to sign informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Veeda Clinical Research

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simonne Lens, MD

Role: STUDY_DIRECTOR

AbbVie sa

Related Links

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Other Identifiers

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P12-129

Identifier Type: -

Identifier Source: org_study_id

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