Moderate-to-severe Chronic Plaque PsoriasisPROMISENCT01076192
Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)
An observational study of Moderate-to-severe Chronic Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-severe Chronic Plaque Psoriasis
- How many people
- 547 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with moderate-to-severe chronic plaque psoriasis
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
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.
Read the 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).
- Keywords
- Moderate Psoriasis, Psoriasis, Severe Psoriasis, Adalimumab, Effectiveness, Safety, Clinical practice
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe chronic plaque psoriasis | Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline and every 6 months up to month 24
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.
Measured: From time of informed consent to the final visit after 2 years of observation
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.
Measured: From time of informed consent to the final visit after 2 years of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate-to-severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IMS Health
- Responsible party
- Sponsor
- Investigators
- Cristina Sancho Sanchez, PharmD, Study director, Abbvie Farmaceutica, S.L.U. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076192
- Sponsor's protocol ID
- P11-067
- Acronym
- PROMISE
- Status last verified
- Dec 2015
- First submitted
- 24 Feb 2010
- Last updated
- 6 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01076192
- Acronym / sponsor ID
- PROMISE / P11-067
- Keywords
- Moderate Psoriasis, Psoriasis, Severe Psoriasis, Adalimumab, Effectiveness, Safety, Clinical practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- IMS Health
- Study start
- Feb 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 6 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe chronic plaque psoriasis | – | –Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with moderate-to-severe chronic plaque psoriasis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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
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.
5 secondary outcomes
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and every 6 months up to month 24
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
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From time of informed consent to the final visit after 2 years of observation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Sancho Sanchez, PharmD study director
Abbvie Farmaceutica, S.L.U. Spain
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Chronic Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.