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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01169987
First received: July 13, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • % of patients on continuous Humira therapy [ Time Frame: Month 24/ Early Termination visit ] [ Designated as safety issue: No ]
  • % of patients on intermittent Humira therapy [ Time Frame: Month 24/ Early Termination visit ] [ Designated as safety issue: No ]
  • % of patients who permanently discontinued Humira therapy [ Time Frame: Month 24/ Early Termination visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Psoriasis Area and Severity Index (PASI)) [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Body Surface Area (BSA)) [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]
  • Clinical evaluations: Psoriasis endpoints (Physician's Global Assessment (PGA)) [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Patient reported outcomes ( Dermatology Life Quality Index (DLQI)) :Quality of life parameters [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]
  • Patient reported outcomes (Work Productivity and Activity Impairment -Psoriasis (WPAI-PSO) : Work Productivity parameters [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]
  • Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. [ Time Frame: At Month 3 ] [ Designated as safety issue: No ]
  • Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Reasons for interrupting or permanently discontinuing Humira and reasons for restarting Humira. [ Time Frame: closest to Month 24 ] [ Designated as safety issue: No ]
  • Laboratory parameters [ Time Frame: At Month 0 ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: At Month 0 ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: closest to Month 3 ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: closest to Month 3 ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: closest to Month 6 ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: closest to Month 6 ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: closest to Month 12 ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: closest to Month 12 ] [ Designated as safety issue: Yes ]
  • laboratory parameters [ Time Frame: closest to Month 18 ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: closest to Month 18 ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: Yes ]
  • Safety parameters (serious adverse events) for Humira [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: Yes ]
  • Metabolic syndrome parameters [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Metabolic syndrome parameters [ Time Frame: closest to Month 3 ] [ Designated as safety issue: No ]
  • Metabolic syndrome parameters [ Time Frame: closest to Month 6 ] [ Designated as safety issue: No ]
  • Metabolic syndrome parameters [ Time Frame: closest to Month 12 ] [ Designated as safety issue: No ]
  • Metabolic syndrome parameters [ Time Frame: closest to Month 18 ] [ Designated as safety issue: No ]
  • Metabolic syndrome parameters [ Time Frame: closest to Month 24/Early Termination visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with chronic plaque psoriasis treated with Humira.
Patients with chronic plaque psoriasis in whom 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with psoriasis followed in university or peripheral hospitals or peripheral private practices with experience in psoriasis patient care.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169987

Locations
Belgium
Site Reference ID/Investigator# 38243
Aalst, Belgium, 9300
Site Reference ID/Investigator# 39043
Aarschot, Belgium, 3200
Site Reference ID/Investigator# 38238
Antwerp, Belgium, 2018
Site Reference ID/Investigator# 38235
Baudour, Belgium, 7331
Site Reference ID/Investigator# 67643
Beerse, Belgium, 2340
Site Reference ID/Investigator# 72833
Brugge, Sint Kruis, Belgium, 8310
Site Reference ID/Investigator# 38227
Brussels, Belgium, 1070
Site Reference ID/Investigator# 38226
Brussels, Belgium, 1200
Site Reference ID/Investigator# 38236
Brussels, Belgium, 1000
Site Reference ID/Investigator# 38230
Dendermonde, Belgium, 9200
Site Reference ID/Investigator# 27342
Edegem, Belgium, 2650
Site Reference ID/Investigator# 38241
Geel, Belgium, 2440
Site Reference ID/Investigator# 74854
Genappe, Belgium, 1470
Site Reference ID/Investigator# 38237
Genk, Belgium, 3600
Site Reference ID/Investigator# 38223
Gent, Belgium, 9000
Site Reference ID/Investigator# 38229
Ghent, Belgium, 9000
Site Reference ID/Investigator# 38231
Ghent, Belgium, 9000
Site Reference ID/Investigator# 39042
Hassalt, Belgium, 3500
Site Reference ID/Investigator# 38250
Huy, Belgium, 4500
Site Reference ID/Investigator# 38244
Kortrijk, Belgium, 8500
Site Reference ID/Investigator# 38245
Lede, Belgium, 9340
Site Reference ID/Investigator# 38224
Liege, Belgium, 4000
Site Reference ID/Investigator# 38242
Lummen, Belgium, 3560
Site Reference ID/Investigator# 38252
Marche-en-Famenne, Belgium, 6900
Site Reference ID/Investigator# 38246
Mons, Belgium, 7000
Site Reference ID/Investigator# 38234
Mons, Belgium, 7000
Site Reference ID/Investigator# 38253
Montigny-le-Tilleul, Belgium, 6110
Site Reference ID/Investigator# 38233
Namur, Belgium, 5000
Site Reference ID/Investigator# 38247
Nivelles, Belgium, 1400
Site Reference ID/Investigator# 38248
Nivelles, Belgium, 1400
Site Reference ID/Investigator# 38239
Sint-Truiden, Belgium, 3800
Site Reference ID/Investigator# 54884
Stavelot, Belgium, 4970
Site Reference ID/Investigator# 54882
Thuin, Belgium, 6530
Site Reference ID/Investigator# 38249
Verlaine, Belgium, 4537
Site Reference ID/Investigator# 38232
Waregem, Belgium, 8790
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research
Investigators
Study Director: Simonne Lens, MD AbbVie sa
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01169987     History of Changes
Other Study ID Numbers: P12-129
Study First Received: July 13, 2010
Last Updated: July 22, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by AbbVie:
Multicenter study

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 27, 2014