PsoriasisPhase 4NCT01511315
The Quality of Life Study in Psoriasis Patients After Ustekinumab Treatment
A Phase 4 study testing Ustekinumab in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Subjects are non-immunocompromised males or females 18 years of age or older
- Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis
- Subject diagnosed at least 6 months prior to entering the study
- Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal)
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
- Are considered eligible according to the following tuberculosis (TB) screening criteria:
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- Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
- Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
- Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB.
- Have a chest radiograph both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
- Subject meets concomitant medication requirements or agrees to complete a washout for restricted medications prior to starting the study.
- Washout Period :
- Must not have initiated or changed any other medications that could affect psoriasis (e.g. beta blockers, lithium salts, antimalarials) within the 4 week period prior to Week 0 or during the study
- Subjects must not have received immunosuppressive, chemotherapy and/or systemic therapy including oral calcineurin inhibitors (such as cyclosporine), retinoids (Vitamin A and analogues), Methotrexate, Azathioprine, 6-thioguanine, Mycophenolate mofetil (MMF), Hydroxyurea, or cytokines (such as interferon-gamma) within the 4 week period prior to Week 0 or during the study
- Subjects must not have received phototherapy (broadband or narrow-band UVB) within the 2 week period prior to Week 0 or during the study.
- Subjects must not have received photochemotherapy (PUVA) within the 4 week period prior to week 0 or during the study
- Subjects must not have received TNF-α inhibitors (such as infliximab, etanercept, adalimumab) within the 12 week period prior to Week 0 or during the study
- Subjects must not have received alefacept within the 12 week period prior to Week 0 or during the study.
- Subjects must not have received ustekinumab within the 12 week period prior to Week 0 or during the study.
- Subjects must not have received treatment with an investigational drug within the previous 4 weeks or 5 half-lives prior to Week 0 (whichever is longer) or participation in another clinical trial within the 4 week period prior to Week 0 or during the study
Who cannot join
- Subject is younger than 18 years of age.
- Subject has less than 10% body surface involvement of his/her psoriasis.
- Subjects with erythrodermic, pustular, or guttate psoriasis
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits
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- Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline.
- Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening.
- Refer to inclusion criteria for information regarding eligibility with a history of latent TB.
- Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
- Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of malignancy or current active infection, including TB.
- Have had a nontuberculous mycobacterial infection or opportunistic infection (eg. Cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
- History of immune compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV, Hepatitis B, and/or Hepatitis C during screening procedures.
- Subject has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
- Subject has a history of or ongoing drug or alcohol abuse
- Subject is not willing to comply with wash-out requirements (see above)
- Subject is known, or suspected of being unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: A Single-Center, Open-Label Study to Assess Change in Psychosocial and Occupational Dimensions With Ustekinumab Treatment of Moderate-to-Severe Psoriasis Evaluated With the Psychological General Well Being (PGWB), Work Productivity and Activity Impairment (WPAI), Psoriasis Quality of Life-12 Items (PQOL-12), and Dermatology Life Quality Index (DLQI)
This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.
Read the detailed description
The primary objective of this study is to demonstrate improvement in psoriasis patient quality of life after 36 weeks with ustekinumab through the use of validated dermatologic and non-dermatologic psychometric instruments.
- Conditions
- Psoriasis
- Being tested
- Ustekinumab
- Keywords
- Moderate to severe psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab | Experimental | Not described Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.
The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Measured: Baseline, 36 weeks
Secondary outcomes (6)
Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline
The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Measured: Baseline, 12 and 24 weeks
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline
The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)
Measured: Baseline, 36 Weeks
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline
The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient's own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.
Measured: Baseline, 12, 24, and 36 Weeks
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline
The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.
Measured: Baseline, 12, 24, and 36 Weeks
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36
The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.
Measured: Weeks 12, 24, and 36
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36
The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.
Measured: Weeks 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 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 PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511315
- Sponsor's protocol ID
- Stelara QoL
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2012
- Last updated
- 12 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study to Assess Change in Psychosocial and Occupational Dimensions With Ustekinumab Treatment of Moderate-to-Severe Psoriasis Evaluated With the Psychological General Well Being (PGWB), Work Productivity and Activity Impairment (WPAI), Psoriasis Quality of Life-12 Items (PQOL-12), and Dermatology Life Quality Index (DLQI)
- ClinicalTrials.gov ID
- NCT01511315
- Acronym / sponsor ID
- Stelara QoL
- Conditions
- Psoriasis
- Keywords
- Moderate to severe psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Posted 12 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.
Detailed description
The primary objective of this study is to demonstrate improvement in psoriasis patient quality of life after 36 weeks with ustekinumab through the use of validated dermatologic and non-dermatologic psychometric instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab | Experimental | Drug: Ustekinumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects are non-immunocompromised males or females 18 years of age or older
- Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis
- Subject diagnosed at least 6 months prior to entering the study
- Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal)
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
Key exclusion criteria (17 listed)
- Subject is younger than 18 years of age.
- Subject has less than 10% body surface involvement of his/her psoriasis.
- Subjects with erythrodermic, pustular, or guttate psoriasis
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabBiologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. | Drug | Ustekinumab |
Primary outcome
Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.
Time frame: Baseline, 36 weeks
The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
6 secondary outcomes
Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline
Time frame: Baseline, 12 and 24 weeks
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline
Time frame: Baseline, 36 Weeks
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline
Time frame: Baseline, 12, 24, and 36 Weeks
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline
Time frame: Baseline, 12, 24, and 36 Weeks
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36
Time frame: Weeks 12, 24, and 36
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36
Time frame: Weeks 12, 24, and 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ustekinumab in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
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 21 inclusion and 17 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 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?
Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline. (time frame: Baseline, 36 weeks). 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 12 Feb 2016.