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

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

Condition(s) targeted: Psoriasis

Phase: N/A

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Simonne Lens, MD, Study Director, Affiliation: AbbVie sa

Summary

This study will document to what extent in daily clinical practice Humira 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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

% of patients on continuous Humira therapy

% of patients on intermittent Humira therapy

% of patients who permanently discontinued Humira therapy

Secondary outcome:

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI))

Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA))

Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA))

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters

Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters

Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira.

Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira.

Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira.

Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira.

Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira.

Laboratory parameters

Safety parameters (serious adverse events) for Humira

Laboratory parameters

Safety parameters (serious adverse events) for Humira

Laboratory parameters

Safety parameters (serious adverse events) for Humira

Laboratory parameters

Safety parameters (serious adverse events) for Humira

laboratory parameters

Safety parameters (serious adverse events) for Humira

Laboratory parameters

Safety parameters (serious adverse events) for Humira

Metabolic syndrome parameters

Metabolic syndrome parameters

Metabolic syndrome parameters

Metabolic syndrome parameters

Metabolic syndrome parameters

Metabolic syndrome parameters

Detailed description: This observational study will document to what extent in daily clinical practice Humira therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. Since psoriasis might be a very invalidating disease with a strong impact on the daily life of the patient, an evaluation will be performed of the effect of the disease on Quality of Life and Work Productivity.

Eligibility

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

Criteria:

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

Locations and Contacts

Site Reference ID/Investigator# 38243, Aalst 9300, Belgium

Site Reference ID/Investigator# 39043, Aarschot 3200, Belgium

Site Reference ID/Investigator# 38238, Antwerp 2018, Belgium

Site Reference ID/Investigator# 38235, Baudour 7331, Belgium

Site Reference ID/Investigator# 67643, Beerse 2340, Belgium

Site Reference ID/Investigator# 72833, Brugge, Sint Kruis 8310, Belgium

Site Reference ID/Investigator# 38226, Brussels 1200, Belgium

Site Reference ID/Investigator# 38227, Brussels 1070, Belgium

Site Reference ID/Investigator# 38236, Brussels 1000, Belgium

Site Reference ID/Investigator# 38230, Dendermonde 9200, Belgium

Site Reference ID/Investigator# 27342, Edegem 2650, Belgium

Site Reference ID/Investigator# 38241, Geel 2440, Belgium

Site Reference ID/Investigator# 74854, Genappe 1470, Belgium

Site Reference ID/Investigator# 38237, Genk 3600, Belgium

Site Reference ID/Investigator# 38223, Ghent 9000, Belgium

Site Reference ID/Investigator# 38229, Ghent 9000, Belgium

Site Reference ID/Investigator# 38231, Ghent 9000, Belgium

Site Reference ID/Investigator# 39042, Hassalt 3500, Belgium

Site Reference ID/Investigator# 38250, Huy 4500, Belgium

Site Reference ID/Investigator# 38244, Kortrijk 8500, Belgium

Site Reference ID/Investigator# 38245, Lede 9340, Belgium

Site Reference ID/Investigator# 38224, Liege 4000, Belgium

Site Reference ID/Investigator# 38242, Lummen 3560, Belgium

Site Reference ID/Investigator# 38252, Marche-en-Famenne 6900, Belgium

Site Reference ID/Investigator# 38234, Mons 7000, Belgium

Site Reference ID/Investigator# 38246, Mons 7000, Belgium

Site Reference ID/Investigator# 38253, Montigny-le-Tilleul 6110, Belgium

Site Reference ID/Investigator# 38233, Namur 5000, Belgium

Site Reference ID/Investigator# 38247, Nivelles 1400, Belgium

Site Reference ID/Investigator# 38248, Nivelles 1400, Belgium

Site Reference ID/Investigator# 38239, Sint-Truiden 3800, Belgium

Site Reference ID/Investigator# 54884, Stavelot 4970, Belgium

Site Reference ID/Investigator# 54882, Thuin 6530, Belgium

Site Reference ID/Investigator# 38249, Verlaine 4537, Belgium

Site Reference ID/Investigator# 38232, Waregem 8790, Belgium

Additional Information

Starting date: May 2010
Last updated: April 7, 2015

Page last updated: August 23, 2015

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