Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)

Moderate-to-severe Chronic Plaque Psoriasis Clinical Trial

— PROMISE  

Official title:

Post-authorization, Observational Study to Evaluate the Effectiveness of Adalimumab (HUMIRA®) on Moderate-severe Psoriasis Under Conditions of Routine Clinical Practice in Spain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076192
• Other study ID #: P11-067
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: December 1, 2015
• Start date: February 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.

Description:

PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 18 years of age or older.

• Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use.

• Patient gives informed consent in writing.

Exclusion Criteria:

• Patients who cannot be treated in accordance with the local product label

• Patient participating or going to participate in a clinical trial during the study follow-up

• Patient with difficulties for adequately reading, understanding and completing a questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Moderate-to-severe Chronic Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	IMS Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)	PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)	PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)	PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)	PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)	PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Mean Change From Baseline in Body Surface Area (BSA) Affected	Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Primary	Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)	The PGA was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.	Baseline, month 1 and every 3 months the first year and every 6 months up to month 24	No
Secondary	Mean Change From Baseline in Dermatology Life Quality Index (DLQI)	DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.	Baseline and every 6 months up to month 24	No
Secondary	Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)	The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.	Baseline and every 6 months up to month 24	No
Secondary	Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)	WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.	Baseline and every 6 months up to month 24	No
Secondary	Number of Participants With Adverse Events of Special Interest (AESIs)	AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.	From time of informed consent to the final visit after 2 years of observation	Yes
Secondary	Number of Participants With Serious Adverse Events (SAEs)	SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion.; See the Reported Adverse Events Section for more details.	From time of informed consent to the final visit after 2 years of observation	Yes

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