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Trial record 7 of 479 for:    PROMISE

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

This study has been completed.
Sponsor:
Collaborator:
IMS Health
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01076192
First received: February 24, 2010
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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.

Condition
Moderate-to-severe Chronic Plaque Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Body Surface Area (BSA) Affected [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA) [ Time Frame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS) [ Time Frame: Baseline and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) [ Time Frame: Baseline and every 6 months up to month 24 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From time of informed consent to the final visit after 2 years of observation ] [ Designated as safety issue: Yes ]
    AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From time of informed consent to the final visit after 2 years of observation ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 547
Study Start Date: February 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate-to-severe chronic plaque psoriasis
Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice

Detailed 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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with moderate-to-severe chronic plaque psoriasis
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076192

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
IMS Health
Investigators
Study Director: Cristina Sancho Sanchez, PharmD Abbvie Farmaceutica, S.L.U. Spain
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01076192     History of Changes
Other Study ID Numbers: P11-067 
Study First Received: February 24, 2010
Results First Received: September 25, 2015
Last Updated: December 1, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by AbbVie:
Moderate Psoriasis
Psoriasis
Severe Psoriasis
Adalimumab
Effectiveness
Safety
Clinical practice

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2016