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

NCT01076192 | Completed Results

• 1 other identifier: P11-067
• Study Type: observational
• Target: 547
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Keywords

Moderate Psoriasis; Psoriasis; Severe Psoriasis; Adalimumab; Effectiveness; Safety; Clinical practice

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (5)

• Mean Change From Baseline in Dermatology Life Quality Index (DLQI)

  Baseline and every 6 months up to month 24

• Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)

  Baseline and every 6 months up to month 24

• Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)

  Baseline and every 6 months up to month 24

• Number of Participants With Adverse Events of Special Interest (AESIs)

  From time of informed consent to the final visit after 2 years of observation

• Number of Participants With Serious Adverse Events (SAEs)

  From time of informed consent to the final visit after 2 years of observation

Study Arms (1)

Moderate-to-severe chronic plaque psoriasis

Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with moderate-to-severe chronic plaque psoriasis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• IMS Health: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Cristina Sancho Sanchez, PharmD

  Abbvie Farmaceutica, S.L.U. Spain

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 6, 2016
• Results First Posted: January 6, 2016

Record last verified: 2015-12