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:
AbbVie (prior sponsor, Abbott)
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
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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
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# 38236 | |
| Brussels, Belgium, 1000 | |
| Site Reference ID/Investigator# 38226 | |
| Brussels, Belgium, 1200 | |
| Site Reference ID/Investigator# 38227 | |
| Brussels, Belgium, 1070 | |
| 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# 38229 | |
| Ghent, Belgium, 9000 | |
| Site Reference ID/Investigator# 38223 | |
| 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# 74853 | |
| Lasne (Plancenoit), Belgium, 1380 | |
| 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# 38234 | |
| Mons, Belgium, 7000 | |
| Site Reference ID/Investigator# 38246 | |
| 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, Brussels
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: | April 19, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by AbbVie:
|
Multicenter study |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Adalimumab |
Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013