PsoriasisPhase 4NCT03718299
A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
A Phase 4 study testing Injections of tildrakizumab in people with Psoriasis, run by Sun Pharmaceutical Industries Limited at 2 sites in United States.
Trial summary
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Injections of tildrakizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2019to 5 Nov 2021
- 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 ≥3% total body surface area plaque psoriasis.
- Subjects are candidates for phototherapy or systemic therapy.
- Subject must be diagnosed at least 6 months prior to entering the study.
- Females must be surgically sterile, postmenopausal for >5 years, or using a highly effective form of birth control (<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is younger than 18 years of age.
- Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
- Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
- Subject is currently enrolled in an investigational drug or device study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 02
Grandville, Michigan, 49418
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.
- Conditions
- Psoriasis
- Being tested
- Injections of tildrakizumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injections of tildrakizumabDrug
given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
| Study group | Role | What they receive |
|---|---|---|
| tildrakizumab 100 mg | Other | Not described Receives: Drug: Injections of tildrakizumab |
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 From Baseline in Psychological General Well-Being Scale
The Psychological General Well-Being scale 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.
The values reported are change in score from baseline.
Measured: baseline, week 28 and week 52
Secondary outcomes (19)
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
The Psychological General Well-Being scale 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.
The values reported are change in score from baseline.
Measured: baseline, weeks 4, 8, 12, 16, 40, 64
Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment.
Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life
Measured: week 64
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment.
Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Measured: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment.
Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Measured: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment.
Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Measured: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Changes From Baseline in Percent Affected Body Surface Area
The percent BSA affected with psoriasis will be estimated at each study visit. The investigator may use the estimate that 1% BSA is equivalent to the area of the subject's closed hand (palm with fingers held together).
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Change From Baseline in Static Physician's Global Assessment
The sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5 with higher scores indicating greater severity.
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
The metric of BSA x sPGA is a multiplication of the percentage BSA covered and the sPGA score.
The scale range for the sPGA is 0 to 5. The scale range for BSA in this study was >=3% (inclusion criterion), which means that it has to be at least 3%, and it can be as high as 100% hypothetically. So the minimum score for sPGA x BSA = 0, and the maximum score is 5 x 100 = 500. So the range for sPGA x BSA in this study was 0 to 500.
The BSA has a range of 0% to 100% where higher percentages indicate a worse outcome or worse disease
The sPGA has a range of 0 (clear) to 5 (severe) where higher values indicate a worse outcome or worse disease.
sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5. BSA covered is reported as percent of body surface area covered. Total score for BSA x sPGA ranges from 0 to 500 with higher scores indicating greater severity.
Measured: weeks 4, 8, 12, 16, 28, 40, 52, 64
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
The PASI is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI analyzes the four regions of the body (head, trunk, upper and lower limbs). It ranges from 0 to 72 with higher scores indicating greater severity.
Measured: baseline, weeks 4,16, 28 and 52
Change From Baseline in Itch-Numeric Rating Scale
The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch
Measured: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Change From Baseline in Scaling-Numeric Rating Scale
The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'.
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Change From Baseline in Pain-Numeric Rating Scale
The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Itch Score of 0
The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Measured: weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Scaling Score of 0
The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Pain Score of 0
The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable.
For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100.
Measured: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
The WPAI is a validated, subject-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism, presenteeism, total activity impairment , and total work productivity impairment. Each WPAI score is expressed as impairment percentages (0-100), with higher scores indicating greater impairment (worse outcomes).
Measured: baseline, weeks 16, 28, 40, 52, 64
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
The TSQM is a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The TSQM domain scores range from 0-100 with higher scores representing higher satisfaction on that domain
Measured: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
The Tildrakizumab Overall Satisfaction Scale is an 11-point simple, self-administered numeric rating scale. Subjects indicate their overall satisfaction by circling the integer that best describes their experience on a scale. A score of 0 indicates 'not satisfied' and 10 indicates 'extremely satisfied'.
Measured: weeks 4, 8, 12, 16, 28, 40, 52, 64
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
The Patient Happiness with Psoriasis Control assessment is an 11-point simple, self- administered numeric rating scale ranging in score from 0 to 10 that is administered at each visit.
Subjects indicate their overall happiness with psoriasis control by circling the integer that best describes their experience on a scale. A score of 0 indicates 'extremely unhappy'. A score of 10 indicates 'extremely happy'.
Measured: weeks 4, 8, 12, 16, 28, 40, 52, 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start16 Jul 2019
- Primary completion2 Nov 2021
- Study completion5 Nov 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718299
- Sponsor's protocol ID
- TIL2018-1
- Status last verified
- Aug 2022
- First submitted
- 15 Oct 2018
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhutani T, Koo J, Heim J, Bhatia N, Mathew J, Ferro T, Vasquez JG. Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Apr;14(4):1019-1025. doi: 10.1007/s13555-024-01131-1. Epub 2024 Apr 4.
PubMed 38575729
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03718299
- Acronym / sponsor ID
- TIL2018-1
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Posted 23 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tildrakizumab 100 mg | Other | Drug: Injections of tildrakizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are non-immunocompromised males or females 18 years of age or older.
- Subjects have ≥3% total body surface area plaque psoriasis.
- Subjects are candidates for phototherapy or systemic therapy.
- Subject must be diagnosed at least 6 months prior to entering the study.
- Females must be surgically sterile, postmenopausal for >5 years, or using a highly effective form of birth control (<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test.
Key exclusion criteria (5 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is younger than 18 years of age.
- Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
- Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
- Subject is currently enrolled in an investigational drug or device study.
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 |
|---|---|---|
| Injections of tildrakizumabgiven at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52 | Drug | tildrakizumab 100 mg |
Primary outcome
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
Time frame: baseline, week 28 and week 52
The Psychological General Well-Being scale 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. The values reported are change in score from baseline.
19 secondary outcomes
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time
Time frame: baseline, weeks 4, 8, 12, 16, 40, 64
Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time
Time frame: week 64
Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5
Time frame: Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64
Changes From Baseline in Percent Affected Body Surface Area
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Change From Baseline in Static Physician's Global Assessment
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time
Time frame: baseline, weeks 4,16, 28 and 52
Change From Baseline in Itch-Numeric Rating Scale
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Change From Baseline in Scaling-Numeric Rating Scale
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Change From Baseline in Pain-Numeric Rating Scale
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Itch Score of 0
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Scaling Score of 0
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Proportion of Patients With Pain Score of 0
Time frame: Weeks 4, 8, 12, 16, 28, 40, 52, and 64
Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time
Time frame: baseline, weeks 16, 28, 40, 52, 64
Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64
Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38575729Bhutani T, Koo J, Heim J, Bhatia N, Mathew J, Ferro T, Vasquez JG. Improvements in Psoriasis-Related Work Productivity with Tildrakizumab: Results from a Phase 4 Real-World Study in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Apr;14(4):1019-1025. doi: 10.1007/s13555-024-01131-1. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injections of tildrakizumab in people with Psoriasis, run by Sun Pharmaceutical Industries Limited at 2 sites 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 5 inclusion and 5 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 23 Feb 2023). 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 From Baseline in Psychological General Well-Being Scale (time frame: baseline, week 28 and week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718299, which also lists 1 linked publication.
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 23 Feb 2023.