PsoriasisNCT00800982
Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis
A study testing Narrow band (310-312 nm) ultraviolet light B phototherapy and etanercept in people with Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Narrow band (310-312 nm) ultraviolet light B phototherapy and etanercept
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonimmunocompromised males or females 18 years of age or older.
- Must be able to read, understand, and speak basic English.
- Body Surface Area (BSA) involvement of greater than 10%.
- Psoriasis Area and Severity Index greater than 10.
- Obese defined as having a Body Mass Index greater than 30.
- Eligible for systemic therapy, particularly etanercept, and Narrow Band Ultraviolet B in the opinion of the investigator.
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- Sign and date the appropriate written informed consent and Health Insurance Portability and Accountability Act authorization
- Negative urine pregnancy test within 7 days before the first dose of etanercept in all women (except those surgically sterile or at least 5 years postmenopausal).
- No evidence of active or latent tuberculosis based on a negative Purified Protein Derivative skin test. Patients with documentation of adequately treated tuberculosis may be enrolled.
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
- Willing and able to self-administer subcutaneous injections or to have a qualified person available to administer subcutaneous injections
- Agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject
- Meets concomitant medication washout requirements
Who cannot join
- Erythrodermic, pustular, or guttate psoriasis
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Known sensitivity to any component of the study medications.
- 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.
- Evidence of latent or active hepatitis B infection as indicated by positive HBsAg test during the screening visit.
- Personal or first degree family history of neurologic disease.
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- 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.
- History of any Tumor Necrosis Factor-α inhibitor use including etanercept, infliximab, and adalimumab within 4 weeks of starting study drug.
- History of non-cutaneous malignancy within the past 5 years.
- History of drug or alcohol abuse. Substance abuse must clearly be documented so those patients with a remote and minor history of drug/alcohol use will still have an opportunity to participate in the study.
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Plans to receive any live vaccines during the study.
- Evidence of photosensitivity disorder (i.e. polymorphous light eruption).
- Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing.
- Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0
- Cannot commit to all the assessments required by the protocol
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
- Cannot or do not wish to comply with the protocol washout requirements (please see section below entitled "Washout Period Prior to Week 0).
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, Pilot Study to Evaluate the Efficacy and Tolerability of Narrow Band UVB Phototherapy in Enhancing Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque-Type Psoriasis
This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients.
Read the detailed description
In Phase I, all subjects will receive etanercept's induction dose, 50 mg twice a week, for a total of 12 weeks. In Phase II, all subjects will receive etanercept's maintenance dose, 50 mg once a week, during Weeks 12-24. Those subjects randomized to the treatment arm will receive NB-UVB phototherapy 3 times a week during Phase II. In order to ensure homogeneity between the NB-UVB arm and non-NB-UVB arm, subjects will be randomized according to their Body Mass Index (BMI). The Psoriasis Area Severity Index (PASI) score and Physician Global Assessment (PGA) will be calculated at each visit to determine the effectiveness of the etanercept and NB-UVB treatment during both phases of the study. The hypothesis is that the combination of NB-UVB phototherapy three times a week and etanercept maintenance dose (50 mg once a week) will enhance the efficacy of the maintenance dose alone in obese patients (BMI >30) with moderate to severe psoriasis.
- Conditions
- Psoriasis
- Being tested
- Narrow band (310-312 nm) ultraviolet light B phototherapy, etanercept
- Keywords
- Obese patients (BMI>30), Patients with 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.
Narrow band (310-312 nm) ultraviolet light B phototherapyProcedure or surgery
Also called nb-UVB, nbUVB, narrowband UVB
Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff
etanerceptDrug
Also called Enbrel
Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Etanercept only) | Active comparator | Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat. Receives: Drug: etanercept |
| 2 (Etanercept + nb-UVB) | Experimental | Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff. Receives: Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy; Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.
Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
Measured: Weeks 12-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2012
- Study completionMar 2012
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Koo, MD, Principal investigator, UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800982
- Sponsor's protocol ID
- KOO - ENBREL-2008
- Other IDs
- H5939-31693-01
- Status last verified
- Mar 2013
- First submitted
- 13 May 2008
- Last updated
- 7 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Park KK, Wu JJ, Koo J. A randomized, 'head-to-head' pilot study comparing the effects of etanercept monotherapy vs. etanercept and narrowband ultraviolet B (NB-UVB) phototherapy in obese psoriasis patients. J Eur Acad Dermatol Venereol. 2013 Jul;27(7):899-906. doi: 10.1111/j.1468-3083.2012.04611.x. Epub 2012 Jun 15.
PubMed 22702846
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Tolerability of Narrow Band UVB Phototherapy in Enhancing Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT00800982
- Acronym / sponsor ID
- KOO - ENBREL-2008
- Conditions
- Psoriasis
- Keywords
- Obese patients (BMI>30), Patients with moderate to severe psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 7 May 2013
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 single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients.
Detailed description
In Phase I, all subjects will receive etanercept's induction dose, 50 mg twice a week, for a total of 12 weeks. In Phase II, all subjects will receive etanercept's maintenance dose, 50 mg once a week, during Weeks 12-24. Those subjects randomized to the treatment arm will receive NB-UVB phototherapy 3 times a week during Phase II. In order to ensure homogeneity between the NB-UVB arm and non-NB-UVB arm, subjects will be randomized according to their Body Mass Index (BMI). The Psoriasis Area Severity Index (PASI) score and Physician Global Assessment (PGA) will be calculated at each visit to determine the effectiveness of the etanercept and NB-UVB treatment during both phases of the study. The hypothesis is that the combination of NB-UVB phototherapy three times a week and etanercept maintenance dose (50 mg once a week) will enhance the efficacy of the maintenance dose alone in obese patients (BMI >30) with moderate to severe psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Etanercept only) | Active comparator | Drug: etanerceptSubjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat. |
| 2 (Etanercept + nb-UVB) | Experimental | Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy, Drug: etanerceptSubjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Nonimmunocompromised males or females 18 years of age or older.
- Must be able to read, understand, and speak basic English.
- Body Surface Area (BSA) involvement of greater than 10%.
- Psoriasis Area and Severity Index greater than 10.
- Obese defined as having a Body Mass Index greater than 30.
Key exclusion criteria (19 listed)
- Erythrodermic, pustular, or guttate psoriasis
- Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- Known sensitivity to any component of the study medications.
- 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.
- Evidence of latent or active hepatitis B infection as indicated by positive HBsAg test during the screening visit.
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 |
|---|---|---|
| Narrow band (310-312 nm) ultraviolet light B phototherapyAlso: nb-UVB, nbUVB, narrowband UVBNarrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff | Procedure or surgery | 2 (Etanercept + nb-UVB) |
| etanerceptAlso: EnbrelEtanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. | Drug | 1 (Etanercept only), 2 (Etanercept + nb-UVB) |
Primary outcome
Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.
Time frame: Weeks 12-24
Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22702846Park KK, Wu JJ, Koo J. A randomized, 'head-to-head' pilot study comparing the effects of etanercept monotherapy vs. etanercept and narrowband ultraviolet B (NB-UVB) phototherapy in obese psoriasis patients. J Eur Acad Dermatol Venereol. 2013 Jul;27(7):899-906. doi: 10.1111/j.1468-3083.2012.04611.x. Epub 2012 Jun 15.
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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.
John Koo, MD principal investigator
UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band (310-312 nm) ultraviolet light B phototherapy and etanercept 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 13 inclusion and 19 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 7 May 2013. 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?
Yes. Results are posted in the registry (first posted 7 May 2013). 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?
Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below. (time frame: Weeks 12-24). 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 NCT00800982, 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 7 May 2013.