PsoriasisNCT02330380
Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
An observational study of Psoriasis and Inflammation, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis, Inflammation
- What is being tested?
- Methotrexate, Ustekinumab and Etanercept
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psoriasis patients
Who may be able to join
- Subjects ages 18-65 years old
- Diagnosis of moderate-to-severe plaque psoriasis
- Plaque affects ≥ 10% of subject's body surface area (BSA)
- Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin
- Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment):
- Discontinue systemic therapies for at least 4 weeks
- Discontinue topical therapies for at least 2 weeks
- Discontinue phototherapies for at least 2 weeks
Who cannot join
- Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period
- Subjects with a critical illness or who are immunocompromised
- Weight is 400lbs or greater
- Subjects who are currently pregnant or breastfeeding
- Subjects who have metal implants
- Subjects who have a pacemaker, stent, or artificial heart valve
Show all 12Show fewer
- History of clinically significant hematological, renal or liver disease
- Patients with known co-morbidities that raise biomarkers such as:
- History of myocardial infarction (MI)
- History of cerebrovascular accident (CVA)
- Significant atherosclerosis (defined as the presence of any carotid plaque; or carotid intimal media thickness (cIMT) >75th percentile for age; or the presence of coronary artery calcium score>100)
- Poorly controlled diabetes (elevated HbA1c > 8.5)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events.
The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time.
Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.
- Conditions
- Psoriasis, Inflammation
- Being tested
- Methotrexate, Ustekinumab, Etanercept, Adalimumab, Acitretin
- Keywords
- psoriasis, comparative effects, inflammation
- Medical subject headings
- Psoriasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Subjects will receive Methotrexate as detailed in the "Group" description.
UstekinumabDrug
Subjects will receive Ustekinumab as detailed in the "Group" description.
EtanerceptDrug
Subjects will receive Etanercept as detailed in the "Group" description.
AdalimumabDrug
Subjects will receive Adalimumab as detailed in the "Group" description.
AcitretinDrug
Subjects will receive Acitretin as detailed in the "Group" description.
UVB Excimer LaserOther
Subjects will receive UVB Excimer Laser therapy as detailed in the "Group" description.
Narrowband UVBOther
Subjects will receive Narrowband UVB as detailed in the "Group" description.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Methotrexate will be dosed weekly. Methotrexate is given as a single, weekly dose and is will be started at 15mg after a first week test dose of 2.5 mg to minimize side effects and achieve efficacy. Weekly dosages will be 15mg. Receives: Drug: Methotrexate | |
| Ustekinumab | Ustekinumab is given as a subcutaneous injection of 45mg if the patient is <100Kg or 90mg if the patient is >100Kg at weeks 0, 4, 16, and every 12 weeks thereafter. Receives: Drug: Ustekinumab | |
| Etanercept | Etanercept will be given in the first 3 months of treatment as 50 mg twice a week (3 or 4 days apart). After 3 months, a reduced dose of 50 mg will be given once per week. Receives: Drug: Etanercept | |
| Adalimumab | Adalimumab will be given in a dose of 40 mg subcutaneously every other week. Receives: Drug: Adalimumab | |
| Acitretin | Acetretin will be prescribed as daily with 25mg if the patient is <80Kg or 35mg if the patient is >80Kg. Receives: Drug: Acitretin | |
| UVB Excimer Laser | Dose determination will be determined by a physician per standard-of-care by performing a Sunburn Test/Minimal Erythemal Dose Test, or by visually evaluating the patient's skin type and thickness of psoriasis plaque. Initial laser dose will be 1-4X the MED depending on the thickness of the plaque. Escalation will be 25-50% increase in dose per treatment if there is no residual erythema, 25% increase per treatment if there is mild residual erythema, and 0% increase per treatment if there is moderate residual erythema. Investigators also have the option to skip a treatment, if there is above moderate erythema, or significant patient discomfort. Patients will receive treatment twice a week. Receives: Other: UVB Excimer Laser | |
| Narrowband UVB | Narrowband UVB (311nm) will be used to treat patients 3X per week with 311nm of UVB light. Uninvolved areas of skin will be covered where possible to minimize excess sun exposure. Patients will be tested for their minimal erythemal dose (MED), after which, based upon Fitzpatrick Scale skin type, a patient will typically beginning with 1-2 minutes based on skin type and gradually increased by 10-15% per treatment dose as tolerated. Receives: Other: Narrowband UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker assessment
The biomarkers examined throughout the study will be assessed. And, an integrated assessment of biomarker behavior over time will be performed. Biomarkers examined will include High sensitivity C-reactive protein (hsCRP), Myeloperoxidase (MPO), resistin, adiponectin and leptin.
Measured: 52 weeks
Secondary outcomes (4)
Changes in coronary artery calcification scoring
Coronary Artery Calcification Scoring (CACS) will be performed at the first and final visits for the study.
Measured: 52 weeks
Changes in PET-MRI
Patients who enroll in this study will receive two PET/MRI scans. The first one will be done prior to beginning their psoriasis therapy during Visit 1 and the second PET/MRI will be done during the Final Visit.
Measured: 52 weeks
Clinical improvement
Psoriasis Area Severity Index (PASI) and Static Physician Global Assessment (sPGA) will be performed throughout the study to monitor clinical improvement.
Measured: 52 weeks
Changes in skin biopsies
In some patients, two 4-6mm punch biopsies will be obtained after the washout period has been observed, one from a psoriasis lesion and one from an adjacent, uninvolved area. Two 4-6mm punch biopsies will also be obtained during the final visit, one from a psoriasis lesion and one from an adjacent, uninvolved area.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Principal investigator, Neil Korman, University Hospitals Cleveland Medical Center
- Investigators
- Neil Korman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330380
- Sponsor's protocol ID
- 04-13-21
- Status last verified
- Oct 2017
- First submitted
- 30 Dec 2014
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
PubMed 20713833Ho SG, Yeung CK, Chan HH. Methotrexate versus traditional Chinese medicine in psoriasis: a randomized, placebo-controlled trial to determine efficacy, safety and quality of life. Clin Exp Dermatol. 2010 Oct;35(7):717-22. doi: 10.1111/j.1365-2230.2009.03693.x.
PubMed 19925489Flytstrom I, Stenberg B, Svensson A, Bergbrant IM. Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial. Br J Dermatol. 2008 Jan;158(1):116-21. doi: 10.1111/j.1365-2133.2007.08284.x. Epub 2007 Nov 6.
PubMed 17986302Heydendael VM, Spuls PI, Opmeer BC, de Borgie CA, Reitsma JB, Goldschmidt WF, Bossuyt PM, Bos JD, de Rie MA. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003 Aug 14;349(7):658-65. doi: 10.1056/NEJMoa021359.
PubMed 12917302Reich K, Sinclair R, Roberts G, Griffiths CE, Tabberer M, Barker J. Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis. Curr Med Res Opin. 2008 May;24(5):1237-54. doi: 10.1185/030079908x291985. Epub 2008 Mar 19.
PubMed 18355421Atteno M, Peluso R, Costa L, Padula S, Iervolino S, Caso F, Sanduzzi A, Lubrano E, Del Puente A, Scarpa R. Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs. Clin Rheumatol. 2010 Apr;29(4):399-403. doi: 10.1007/s10067-009-1340-7.
PubMed 20066450Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, Unnebrink K, Kaul M, Camez A; CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008 Mar;158(3):558-66. doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
PubMed 18047523Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
PubMed 21576552Gelfand JM, Wan J, Callis Duffin K, Krueger GG, Kalb RE, Weisman JD, Sperber BR, Stierstorfer MB, Brod BA, Schleicher SM, Bebo BF Jr, Troxel AB, Shin DB, Steinemann JM, Goldfarb J, Yeung H, Van Voorhees AS. Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting. Arch Dermatol. 2012 Apr;148(4):487-94. doi: 10.1001/archdermatol.2012.370.
PubMed 22508874
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
- ClinicalTrials.gov ID
- NCT02330380
- Acronym / sponsor ID
- 04-13-21
- Conditions
- Psoriasis, Inflammation
- Keywords
- psoriasis, comparative effects, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
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 prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events.
The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time.
Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | – | Drug: MethotrexateMethotrexate will be dosed weekly. Methotrexate is given as a single, weekly dose and is will be started at 15mg after a first week test dose of 2.5 mg to minimize side effects and achieve efficacy. Weekly dosages will be 15mg. |
| Ustekinumab | – | Drug: UstekinumabUstekinumab is given as a subcutaneous injection of 45mg if the patient is <100Kg or 90mg if the patient is >100Kg at weeks 0, 4, 16, and every 12 weeks thereafter. |
| Etanercept | – | Drug: EtanerceptEtanercept will be given in the first 3 months of treatment as 50 mg twice a week (3 or 4 days apart). After 3 months, a reduced dose of 50 mg will be given once per week. |
| Adalimumab | – | Drug: AdalimumabAdalimumab will be given in a dose of 40 mg subcutaneously every other week. |
| Acitretin | – | Drug: AcitretinAcetretin will be prescribed as daily with 25mg if the patient is <80Kg or 35mg if the patient is >80Kg. |
| UVB Excimer Laser | – | Other: UVB Excimer LaserDose determination will be determined by a physician per standard-of-care by performing a Sunburn Test/Minimal Erythemal Dose Test, or by visually evaluating the patient's skin type and thickness of psoriasis plaque. Initial laser dose will be 1-4X the MED depending on the thickness of the plaque. Escalation will be 25-50% increase in dose per treatment if there is no residual erythema, 25% increase per treatment if there is mild residual erythema, and 0% increase per treatment if there is moderate residual erythema. Investigators also have the option to skip a treatment, if there is above moderate erythema, or significant patient discomfort. Patients will receive treatment twice a week. |
| Narrowband UVB | – | Other: Narrowband UVBNarrowband UVB (311nm) will be used to treat patients 3X per week with 311nm of UVB light. Uninvolved areas of skin will be covered where possible to minimize excess sun exposure. Patients will be tested for their minimal erythemal dose (MED), after which, based upon Fitzpatrick Scale skin type, a patient will typically beginning with 1-2 minutes based on skin type and gradually increased by 10-15% per treatment dose as tolerated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psoriasis patients
Key inclusion criteria (8 listed)
- Subjects ages 18-65 years old
- Diagnosis of moderate-to-severe plaque psoriasis
- Plaque affects ≥ 10% of subject's body surface area (BSA)
- Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin
- Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment):
Key exclusion criteria (12 listed)
- Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period
- Subjects with a critical illness or who are immunocompromised
- Weight is 400lbs or greater
- Subjects who are currently pregnant or breastfeeding
- Subjects who have metal implants
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 |
|---|---|---|
| MethotrexateSubjects will receive Methotrexate as detailed in the "Group" description. | Drug | Methotrexate |
| UstekinumabSubjects will receive Ustekinumab as detailed in the "Group" description. | Drug | Ustekinumab |
| EtanerceptSubjects will receive Etanercept as detailed in the "Group" description. | Drug | Etanercept |
| AdalimumabSubjects will receive Adalimumab as detailed in the "Group" description. | Drug | Adalimumab |
| AcitretinSubjects will receive Acitretin as detailed in the "Group" description. | Drug | Acitretin |
| UVB Excimer LaserSubjects will receive UVB Excimer Laser therapy as detailed in the "Group" description. | Other | UVB Excimer Laser |
| Narrowband UVBSubjects will receive Narrowband UVB as detailed in the "Group" description. | Other | Narrowband UVB |
Primary outcome
Biomarker assessment
Time frame: 52 weeks
The biomarkers examined throughout the study will be assessed. And, an integrated assessment of biomarker behavior over time will be performed. Biomarkers examined will include High sensitivity C-reactive protein (hsCRP), Myeloperoxidase (MPO), resistin, adiponectin and leptin.
4 secondary outcomes
Changes in coronary artery calcification scoring
Time frame: 52 weeks
Changes in PET-MRI
Time frame: 52 weeks
Clinical improvement
Time frame: 52 weeks
Changes in skin biopsies
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 20713833Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
- Background: PubMed 19925489Ho SG, Yeung CK, Chan HH. Methotrexate versus traditional Chinese medicine in psoriasis: a randomized, placebo-controlled trial to determine efficacy, safety and quality of life. Clin Exp Dermatol. 2010 Oct;35(7):717-22. doi: 10.1111/j.1365-2230.2009.03693.x.
- Background: PubMed 17986302Flytstrom I, Stenberg B, Svensson A, Bergbrant IM. Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial. Br J Dermatol. 2008 Jan;158(1):116-21. doi: 10.1111/j.1365-2133.2007.08284.x. Epub 2007 Nov 6.
- Background: PubMed 12917302Heydendael VM, Spuls PI, Opmeer BC, de Borgie CA, Reitsma JB, Goldschmidt WF, Bossuyt PM, Bos JD, de Rie MA. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003 Aug 14;349(7):658-65. doi: 10.1056/NEJMoa021359.
- Background: PubMed 18355421Reich K, Sinclair R, Roberts G, Griffiths CE, Tabberer M, Barker J. Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis. Curr Med Res Opin. 2008 May;24(5):1237-54. doi: 10.1185/030079908x291985. Epub 2008 Mar 19.
- Background: PubMed 20066450Atteno M, Peluso R, Costa L, Padula S, Iervolino S, Caso F, Sanduzzi A, Lubrano E, Del Puente A, Scarpa R. Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs. Clin Rheumatol. 2010 Apr;29(4):399-403. doi: 10.1007/s10067-009-1340-7.
- Background: PubMed 18047523Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, Unnebrink K, Kaul M, Camez A; CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008 Mar;158(3):558-66. doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
- Background: PubMed 21576552Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
- Background: PubMed 22508874Gelfand JM, Wan J, Callis Duffin K, Krueger GG, Kalb RE, Weisman JD, Sperber BR, Stierstorfer MB, Brod BA, Schleicher SM, Bebo BF Jr, Troxel AB, Shin DB, Steinemann JM, Goldfarb J, Yeung H, Van Voorhees AS. Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting. Arch Dermatol. 2012 Apr;148(4):487-94. doi: 10.1001/archdermatol.2012.370.
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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.
Neil Korman, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Inflammation, run by University Hospitals Cleveland Medical Center 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 8 inclusion and 12 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 13 Oct 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarker assessment (time frame: 52 weeks). 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 NCT02330380, which also lists 9 linked publications.
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 13 Oct 2017.