InflammationPhase 3NCT00121615
Study of Etanercept in the Treatment of Psoriasis in Adult Subjects
A Phase 3 study testing etanercept in people with Inflammation and Psoriasis, run by Amgen.
Trial summary
The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Psoriasis
- What is being tested?
- etanercept
- How many people
- 391 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to 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: - Subjects who completed study 20030115 or 20030117 qualify to enroll into this study (provided that they meet all inclusion/exclusion criteria). - Heterosexually active men and women of child-bearing potential must agree to use a medically acceptable form of contraception throughout the study. - Subject or designee must have the ability to self-inject investigational product. - Subject must be capable of understanding and giving written voluntary informed consent. - Negative serum pregnancy test less than or equal to 14 days prior to the first dose of investigational product in all female subjects (except those surgically sterile or at least 5 years postmenopausal) Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the baseline visit - Any adverse event or infection at the time of the baseline visit or at any time during the previous etanercept psoriasis study which, in the opinion of Amgen or the Investigator, would preclude participation in the study - Presence of a serious infection less than or equal to 30 days prior to the baseline visit - Evidence of skin conditions at the baseline visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis - Previous receipt of anti-TNF agent(s) other than etanercept - Receipt of any investigational product(s), other than etanercept, less than or equal to 30 days prior to first dose of investigational product in this study - Receipt of anti-CD4 or diphtheria IL-2 fusion protein less than or equal to 24 weeks prior to first dose of investigational product in this study - Psoralen and ultraviolet A (PUVA) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Ultraviolet A (UVA) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Ultraviolet B (UVB) light therapy less than or equal to 14 days prior to first dose of investigational product in this study - Receipt of any other systemic psoriasis therapy or oral or parenteral corticosteroids less than or equal to 14 days prior to first dose of investigational product in this study - Pregnant or breast-feeding females - Significant concurrent medical conditions prior to enrollment, including: uncontrolled hypertension (defined as systolic blood pressure measurement of greater than 180 mm Hg or an untreated diastolic blood pressure of greater than 110 mm Hg); myocardial infarction less than or equal to 52 weeks prior to baseline visit; unstable angina pectoris; uncompensated congestive heart failure; severe pulmonary disease requiring hospitalization or supplemental oxygen therapy; diagnosis of multiple sclerosis or any other demyelinating disease; insulin-dependent diabetes mellitus; history of cancer (other than in-situ cervical cancer or resected cutaneous basal cell or squamous cell carcinoma) less than or equal to 5 years prior to administration of first dose of investigational product; open cutaneous ulcers; known human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) positive; any condition that might cause this study to be detrimental to the subject, in the judgment of the investigator.
About this study
Official title: An Open-Label, Long-Term Extension Study to Assess the Safety and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.
- Conditions
- Inflammation, Psoriasis
- Being tested
- etanercept
- Keywords
- Clinical Trials
- Medical subject headings
- Inflammation, Psoriasis
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.
Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
Secondary outcomes (1)
Longitudinal changes from baseline for the Physician and Patient Global Assessments and DLQI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 391 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121615
- Sponsor's protocol ID
- 20040216
- Status last verified
- Mar 2009
- First submitted
- 30 Jun 2005
- Last updated
- 6 Mar 2009
- Results posted
- No
Publications
Papp KA, Poulin Y, Bissonnette R, Bourcier M, Toth D, Rosoph L, Poulin-Costello M, Setterfield M, Syrotuik J. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012 Feb;66(2):e33-45. doi: 10.1016/j.jaad.2010.07.026. Epub 2010 Sep 17.
PubMed 20850895
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. 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 and Efficacy of Etanercept in the Treatment of Psoriasis in Adult Subjects
- ClinicalTrials.gov ID
- NCT00121615
- Acronym / sponsor ID
- 20040216
- Conditions
- Inflammation, Psoriasis
- Keywords
- Clinical Trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2004
- First posted
- 21 Jul 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 objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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
Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.
1 secondary outcome
Longitudinal changes from baseline for the Physician and Patient Global Assessments and DLQI
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 6 Mar 2009.
- Derived from this study: PubMed 20850895Papp KA, Poulin Y, Bissonnette R, Bourcier M, Toth D, Rosoph L, Poulin-Costello M, Setterfield M, Syrotuik J. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012 Feb;66(2):e33-45. doi: 10.1016/j.jaad.2010.07.026. Epub 2010 Sep 17.
- 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 Inflammation and 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 6 Mar 2009. 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 serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.. 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 NCT00121615, 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 6 Mar 2009.