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PsoriasisPhase 4NCT00791765

Moderate to Severe Plaque Psoriasis With Scalp Involvement

A Phase 4 study testing Etanercept in people with Psoriasis, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
No sites listed yet
Study dates
Oct 2008to Mar 2010
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

  • Must provide written informed consent before any study-specific procedure
  • Be male or female greater than or equal to 18 years of age at time of screening
  • Has stable moderate to severe plaque psoriasis for at least 6 months
  • Affected body surface area (BSA) greater than or equal to 10%
  • Psoriasis Area and Severity Index (PASI) score greater than or equal to 10
  • At least 30 percent affected scalp surface area
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  • Psoriasis Scalp Severity Index (PSSI) score greater than or equal to 15
  • Candidate for systemic therapy or phototherapy in the opinion of the investigator
  • Negative test for hepatitis B surface antigen, hepatitis C antibody, and Human Immunodeficiency Virus (HIV)
  • Negative serum pregnancy test for female subjects (unless 3 years post menopausal or surgically sterile)
  • Willing to use medically acceptable form of birth control for duration of study
  • Negative Purified Protein Derivative (PPD) within 30 days prior to first dose of study drug

Who cannot join

  • Any active infection
  • Significant concurrent medical conditions, including: Insulin dependent diabetes mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable angina pectoris; Uncontrolled hypertension; Severe pulmonary disease [requiring oxygen therapy or hospitalization]; Systemic lupus erythematosus; Multiple sclerosis or any other demyelinating disease; Active malignancy
  • Any condition, in opinion of study doctor, that might cause this study to be detrimental to subject
  • History of cancer within 5 years before first dose of study drug
  • Skin conditions other than psoriasis that would interfere with evaluations of the effect of study medications on psoriasis
  • Presence of guttate, erythrodermic or pustular psoriasis
Show all 15Show fewer
  • Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of study drug
  • Use of tar shampoos within 14 days of first dose of study drug
  • Use of following therapies within 28 days of first dose of study drug: IV or oral cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra
  • Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (TNF) biologic therapies within 3 months of the first dose of study drug. Prior anti-TNF use will not be permitted if discontinued due to lack of efficacy, an adverse event, or non-compliance.
  • Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug
  • Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) of randomization
  • Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count less than 125,000/mm^3, white blood cell count less than 3,500 cells/mm^3, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results
  • Patient is pregnant or breast feeding
  • Presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Treating Scalp Involvement in Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.

Conditions
Psoriasis
Being tested
Etanercept, Placebo
Keywords
Scalp, Psoriasis, Plaque Psoriasis, Skin Diseases, Moderate to severe plaque psoriasis, etanercept
Medical subject headings
Psoriasis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptBiological

    Also called Enbrel®

    Etanercept for subcutaneous injection.

  • PlaceboBiological

    Placebo for subcutaneous injection.

Study groups in NCT00791765
Study groupRoleWhat they receive
Placebo BIW/Etanercept 50 mg BIWExperimentalParticipants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
Receives: Biological: Etanercept; Biological: Placebo
Etanercept 50 mg BIW/Etanercept 50 mg QWExperimentalParticipants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
Receives: Biological: Etanercept; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12

    The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.

    Measured: Baseline and Week 12

Secondary outcomes (3)

  1. Percentage of Participants With PSSI 75% Response at Week 12

    Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.

    Measured: Baseline and Week 12

  2. Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12

    Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.

    Measured: Baseline and Week 24

  3. Patient Satisfaction With Treatment at Week 12

    This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from "very dissatisfied" to "very satisfied") to indicate his or her level of satisfaction with the medication's control of psoriasis.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2010
  4. Study completionMar 2010

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00791765
Sponsor's protocol ID
20080014
Status last verified
Jul 2014
First submitted
14 Nov 2008
Last updated
23 Jul 2014

Publications

  • Bagel J, Lynde C, Tyring S, Kricorian G, Shi Y, Klekotka P. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012 Jul;67(1):86-92. doi: 10.1016/j.jaad.2011.07.034. Epub 2011 Oct 20.

    PubMed 22014541

  • Tyring S, Bagel J, Lynde C, Klekotka P, Thompson EH, Gandra SR, Shi Y, Kricorian G. Patient-reported outcomes in moderate-to-severe plaque psoriasis with scalp involvement: results from a randomized, double-blind, placebo-controlled study of etanercept. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):125-8. doi: 10.1111/j.1468-3083.2011.04394.x. Epub 2011 Dec 21. No abstract available.

    PubMed 22188302

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etanercept in people with Psoriasis, run by Amgen.

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 12 inclusion and 15 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 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 7 Nov 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?

Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12 (time frame: Baseline and Week 12). 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 NCT00791765, which also lists 2 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 23 Jul 2014.

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