Clinical trial NCT01076192: Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate-to-severe Chronic Plaque Psoriasis
Keywords: Moderate Psoriasis
Psoriasis
Severe Psoriasis
Adalimumab
Effectiveness
Safety
Clinical practice
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: IMS Health
First posted: 2010-02-26
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with moderate-to-severe chronic plaque psoriasis

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.

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 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

Primary outcomes:
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Mean Change From Baseline in Body Surface Area (BSA) Affected
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
measure: Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)
timeFrame: Baseline, month 1 and every 3 months the first year and every 6 months up to month 24
Secondary outcomes:
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and every 6 months up to month 24
measure: Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)
timeFrame: Baseline and every 6 months up to month 24
measure: Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
timeFrame: Baseline and every 6 months up to month 24
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From time of informed consent to the final visit after 2 years of observation
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From time of informed consent to the final visit after 2 years of observation
Other outcomes:
Locations:
Study officials:
affiliation: Abbvie Farmaceutica, S.L.U. Spain
name: Cristina Sancho Sanchez, PharmD
role: STUDY_DIRECTOR
References: