PsoriasisPhase 3NCT00111449
Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
A Phase 3 study testing Etanercept in people with Psoriasis, run by Amgen.
Trial summary
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with 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
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
About this study
Official title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
- Conditions
- Psoriasis
- Being tested
- Etanercept
- Keywords
- Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe
- Medical subject headings
- Psoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Secondary outcomes (9)
Dermatology Live Quality Index (DLQI) response at week 12
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Psoriasis pain (VAS) at week 12
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Adverse events, infections injection site reactions during long-term therapy
Serious adverse events and infections during long-term therapy
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2005 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111449
- Sponsor's protocol ID
- 20030117
- Status last verified
- May 2013
- First submitted
- 20 May 2005
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Krishnan R, Cella D, Leonardi C, Papp K, Gottlieb AB, Dunn M, Chiou CF, Patel V, Jahreis A. Effects of etanercept therapy on fatigue and symptoms of depression in subjects treated for moderate to severe plaque psoriasis for up to 96 weeks. Br J Dermatol. 2007 Dec;157(6):1275-7. doi: 10.1111/j.1365-2133.2007.08205.x. Epub 2007 Oct 4. No abstract available.
PubMed 17916204Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006 Jan 7;367(9504):29-35. doi: 10.1016/S0140-6736(05)67763-X.
PubMed 16399150Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26. doi: 10.1001/archderm.143.6.719.
PubMed 17576937Papp K, Poulin Y, Vieira A, Shelton J, Poulin-Costello M. Disease characteristics in patients with and without psoriatic arthritis treated with etanercept. J Eur Acad Dermatol Venereol. 2014 May;28(5):581-9. doi: 10.1111/jdv.12138. Epub 2013 Mar 7.
PubMed 23465037
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
- ClinicalTrials.gov ID
- NCT00111449
- Acronym / sponsor ID
- 20030117
- Conditions
- Psoriasis
- Keywords
- Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jun 2003
- First posted
- 23 May 2005 (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.
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Etanercept | Drug | – |
Primary outcome
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
9 secondary outcomes
Dermatology Live Quality Index (DLQI) response at week 12
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Psoriasis pain (VAS) at week 12
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Adverse events, infections injection site reactions during long-term therapy
Serious adverse events and infections during long-term therapy
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
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 15 May 2013.
- Results publication: PubMed 17916204Krishnan R, Cella D, Leonardi C, Papp K, Gottlieb AB, Dunn M, Chiou CF, Patel V, Jahreis A. Effects of etanercept therapy on fatigue and symptoms of depression in subjects treated for moderate to severe plaque psoriasis for up to 96 weeks. Br J Dermatol. 2007 Dec;157(6):1275-7. doi: 10.1111/j.1365-2133.2007.08205.x. Epub 2007 Oct 4. No abstract available.
- Results publication: PubMed 16399150Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006 Jan 7;367(9504):29-35. doi: 10.1016/S0140-6736(05)67763-X.
- Results publication: PubMed 17576937Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26. doi: 10.1001/archderm.143.6.719.
- Derived from this study: PubMed 23465037Papp K, Poulin Y, Vieira A, Shelton J, Poulin-Costello M. Disease characteristics in patients with and without psoriatic arthritis treated with etanercept. J Eur Acad Dermatol Venereol. 2014 May;28(5):581-9. doi: 10.1111/jdv.12138. Epub 2013 Mar 7.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 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?
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 15 May 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.. 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 NCT00111449, which also lists 4 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 15 May 2013.