PsoriasisPhase 3NCT00111436
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
A Phase 3 study testing Etanercept in people with Psoriasis, run by Amgen.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jul 2005
- 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
Who may be able to join
- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)
Who cannot join
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- Pregnant or breast-feeding females
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
About this study
Official title: An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
- Conditions
- Psoriasis
- Being tested
- Etanercept
- Keywords
- Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe, extension
- 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
Enbrel 50 mg once weekly or 50 mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 50 mg | Experimental | 50 mg once weekly Receives: Drug: Etanercept |
| 100 mg | Experimental | 50 mg twice weekly Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events, including infectious episodes
Measured: 72 weeks
Changes from baseline in laboratory values
Measured: 72 weeks
Secondary outcomes (5)
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
Measured: 72 weeks
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
Measured: 72 weeks
Patient Global Assessment of psoriasis
Measured: 72 weeks
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
Measured: 72 weeks
Changes from baseline in SF-36 Health Survey scores
Measured: 72 weeks
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 startApr 2003
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111436
- Sponsor's protocol ID
- 20030115
- Status last verified
- Apr 2013
- First submitted
- 20 May 2005
- Last updated
- 26 Apr 2013
- Results posted
- No
Publications
Elewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x.
PubMed 17199580Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37.
PubMed 20684143
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
- ClinicalTrials.gov ID
- NCT00111436
- Acronym / sponsor ID
- 20030115
- Conditions
- Psoriasis
- Keywords
- Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe, extension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Apr 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- 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 evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mg | Experimental | Drug: Etanercept50 mg once weekly |
| 100 mg | Experimental | Drug: Etanercept50 mg twice weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)
Key exclusion criteria (3 listed)
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- Pregnant or breast-feeding females
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
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 |
|---|---|---|
| EtanerceptEnbrel 50 mg once weekly or 50 mg twice weekly | Drug | 100 mg, 50 mg |
Primary outcome
Subject incidence of adverse events, including infectious episodes
Time frame: 72 weeks
Changes from baseline in laboratory values
Time frame: 72 weeks
5 secondary outcomes
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
Time frame: 72 weeks
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
Time frame: 72 weeks
Patient Global Assessment of psoriasis
Time frame: 72 weeks
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
Time frame: 72 weeks
Changes from baseline in SF-36 Health Survey scores
Time frame: 72 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 26 Apr 2013.
- Results publication: PubMed 17199580Elewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x.
- Results publication: PubMed 20684143Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37.
- AmgenTrials clinical trials websiteLink 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?
The sponsor lists 1 inclusion and 3 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 26 Apr 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?
Subject incidence of adverse events, including infectious episodes (time frame: 72 weeks). The study lists 2 primary outcomes in all. 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 NCT00111436, 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 26 Apr 2013.