- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322580
An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients (DERM)
December 1, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen
The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.
Study Overview
Study Type
Observational
Enrollment (Actual)
56
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)
Description
Inclusion Criteria:
- Age from 18 years on, male or female
- Established diagnosis of psoriasis
- Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.
- Patients who give informed consent for this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Psoriasis patients who receive Enbrel® therapy
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
trough serum etanercept concentration
Time Frame: one year
|
one year
|
anti-etanercept serum concentration
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2016
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- S56818
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on etanercept
-
EMSWithdrawnRheumatoid ArthritisBrazil
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedAnkylosing Spondylitis
-
LG Life SciencesCompletedHealthyKorea, Republic of
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...CompletedAnkylosing SpondylitisChina
-
Shanghai Celgen Bio-Pharmaceutical Co.,LtdUnknownPsoriasis | Plaque PsoriasisChina
-
AmgenCompletedArthritis, Rheumatoid; Arthritis, PsoriaticUnited States, Puerto Rico
-
Sun Yat-sen UniversityCompleted
-
AmgenCompletedRheumatoid Arthritis | Plaque PsoriasisUnited States, Canada
-
Samsung Bioepis Co., Ltd.CompletedRheumatoid ArthritisPoland, United Kingdom