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NCT01169987 Clinical Trial

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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01169987
Other study ID # P12-129
Secondary ID
Status Completed
Phase N/A
First received July 13, 2010
Last updated April 7, 2015
Start date May 2010
Est. completion date March 2015

Study information
Verified date April 2015
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Site Reference ID/Investigator# 38243 Aalst
Belgium Site Reference ID/Investigator# 39043 Aarschot
Belgium Site Reference ID/Investigator# 38238 Antwerp
Belgium Site Reference ID/Investigator# 38235 Baudour
Belgium Site Reference ID/Investigator# 67643 Beerse
Belgium Site Reference ID/Investigator# 72833 Brugge, Sint Kruis
Belgium Site Reference ID/Investigator# 38226 Brussels
Belgium Site Reference ID/Investigator# 38227 Brussels
Belgium Site Reference ID/Investigator# 38236 Brussels
Belgium Site Reference ID/Investigator# 38230 Dendermonde
Belgium Site Reference ID/Investigator# 27342 Edegem
Belgium Site Reference ID/Investigator# 38241 Geel
Belgium Site Reference ID/Investigator# 74854 Genappe
Belgium Site Reference ID/Investigator# 38237 Genk
Belgium Site Reference ID/Investigator# 38223 Ghent
Belgium Site Reference ID/Investigator# 38229 Ghent
Belgium Site Reference ID/Investigator# 38231 Ghent
Belgium Site Reference ID/Investigator# 39042 Hassalt
Belgium Site Reference ID/Investigator# 38250 Huy
Belgium Site Reference ID/Investigator# 38244 Kortrijk
Belgium Site Reference ID/Investigator# 38245 Lede
Belgium Site Reference ID/Investigator# 38224 Liege
Belgium Site Reference ID/Investigator# 38242 Lummen
Belgium Site Reference ID/Investigator# 38252 Marche-en-Famenne
Belgium Site Reference ID/Investigator# 38234 Mons
Belgium Site Reference ID/Investigator# 38246 Mons
Belgium Site Reference ID/Investigator# 38253 Montigny-le-Tilleul
Belgium Site Reference ID/Investigator# 38233 Namur
Belgium Site Reference ID/Investigator# 38247 Nivelles
Belgium Site Reference ID/Investigator# 38248 Nivelles
Belgium Site Reference ID/Investigator# 38239 Sint-Truiden
Belgium Site Reference ID/Investigator# 54884 Stavelot
Belgium Site Reference ID/Investigator# 54882 Thuin
Belgium Site Reference ID/Investigator# 38249 Verlaine
Belgium Site Reference ID/Investigator# 38232 Waregem

Sponsors (2)
Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott) Veeda Clinical Research

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary % of patients on continuous Humira therapy Month 24/ Early Termination visit No
Primary % of patients on intermittent Humira therapy Month 24/ Early Termination visit No
Primary % of patients who permanently discontinued Humira therapy Month 24/ Early Termination visit No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) At Month 0 No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) At Month 0 No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) At Month 0 No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) closest to Month 3 No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) closest to Month 3 No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) closest to Month 3 No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) closest to Month 6 No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) closest to Month 6 No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) closest to Month 6 No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) closest to Month 12 No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) closest to Month 12 No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) closest to Month 12 No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) closest to Month 18 No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) closest to Month 18 No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) closest to Month 18 No
Secondary Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) closest to Month 24/Early Termination visits No
Secondary Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) closest to Month 24/Early Termination visits No
Secondary Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) closest to Month 24/Early Termination visits No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters At Month 0 No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters At Month 0 No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters closest to Month 3 No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters closest to Month 3 No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters closest to Month 6 No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters closest to Month 6 No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters closest to Month 12 No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters closest to Month 12 No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters closest to Month 18 No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters closest to Month 18 No
Secondary Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters closest to Month 24/Early Termination visits No
Secondary Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters closest to Month 24/Early Termination visits No
Secondary Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. At Month 3 No
Secondary Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. closest to Month 6 No
Secondary Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. closest to Month 12 No
Secondary Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. closest to Month 18 No
Secondary Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. closest to Month 24 No
Secondary Laboratory parameters At Month 0 Yes
Secondary Safety parameters (serious adverse events) for Humira At Month 0 Yes
Secondary Laboratory parameters closest to Month 3 Yes
Secondary Safety parameters (serious adverse events) for Humira closest to Month 3 Yes
Secondary Laboratory parameters closest to Month 6 Yes
Secondary Safety parameters (serious adverse events) for Humira closest to Month 6 Yes
Secondary Laboratory parameters closest to Month 12 Yes
Secondary Safety parameters (serious adverse events) for Humira closest to Month 12 Yes
Secondary laboratory parameters closest to Month 18 Yes
Secondary Safety parameters (serious adverse events) for Humira closest to Month 18 Yes
Secondary Laboratory parameters closest to Month 24/Early Termination visits Yes
Secondary Safety parameters (serious adverse events) for Humira closest to Month 24/Early Termination visits Yes
Secondary Metabolic syndrome parameters At Month 0 No
Secondary Metabolic syndrome parameters closest to Month 3 No
Secondary Metabolic syndrome parameters closest to Month 6 No
Secondary Metabolic syndrome parameters closest to Month 12 No
Secondary Metabolic syndrome parameters closest to Month 18 No
Secondary Metabolic syndrome parameters closest to Month 24/Early Termination visits No
See also
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Completed NCT04841187 - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting NCT03927352 - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis Phase 3
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Recruiting NCT06027034 - Effectiveness of a Digital Health Application for Psoriasis N/A
Not yet recruiting NCT06050330 - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study N/A
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Completed NCT03998683 - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis Phase 3
Terminated NCT03556202 - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06077331 - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT04316585 - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants Phase 1
Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Completed NCT05003531 - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Phase 2

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