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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.

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 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.

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.

What is being measured

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

  1. Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Secondary outcomes (1)
  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.

  1. First posted21 Jul 2005 (estimated)
  2. Study startOct 2004

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
391 participants
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

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.

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