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

This study has been completed.
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: June 13, 2016
Last verified: June 2016

July 13, 2010
June 13, 2016
May 2010
March 2015   (final data collection date for primary outcome measure)
Adalimumab Treatment Retention Status [ Time Frame: Month 24/ Early Termination visit ] [ Designated as safety issue: No ]
Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.
  • % 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 ]
Complete list of historical versions of study NCT01169987 on ClinicalTrials.gov Archive Site
  • Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months) ] [ Designated as safety issue: No ]
    The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories "Clear/Minimal" or "Mild/Moderate/Severe/Very Severe (M/Md/S/VS)," and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status [ Time Frame: Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months) ] [ Designated as safety issue: No ]
    Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).
  • 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 ]
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 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.
Not Provided
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
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
March 2015
March 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 to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium
 
NCT01169987
P12-129
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research
Study Director: Simonne Lens, MD AbbVie sa
AbbVie
June 2016

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