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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, Brussels
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01169987
First received: July 13, 2010
Last updated: April 19, 2013
Last verified: April 2013
History of Changes

July 13, 2010
April 19, 2013
May 2010
January 2015   (final data collection date for primary outcome measure)
  • % 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 ]
Same as current
Complete list of historical versions of study NCT01169987 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life
Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with psoriasis followed in university or peripheral hospitals or peripheral private practices with experience in psoriasis patient care
Psoriasis
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01169987
P12-129
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research, Brussels
Study Director: Simonne Lens, MD AbbVie SA
AbbVie
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP