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A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Rheumatologisches MVZ Dresden GmbH im Gesundheitszentrum Dresden - Klotzsche (GZDK)
Dresden, Sachsen, 01109 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of RA, axSpA, PsA or PsO

- No prior treatment with etanercept and eligibility for treatment with etanercept
according to the summary of product characteristics.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- The contraindications, special warnings, and precautions according to the summary of
product characteristics for etanercept shall apply.

- The additional documentation of the patient in another post-marketing study with
etanercept is not permitted.

NCT02486302
Pfizer
Recruiting
A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

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Descriptive Information
Brief TitleA Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
Official TitleA PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT
Brief SummaryThe purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAmbulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
Condition
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Axial Spondyloarthritis
  • Plaque Psoriasis
InterventionDrug: Etanercept
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Study Groups/CohortsObservation Group
Intervention: Drug: Etanercept
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 29, 2019)
1534
Original Estimated Enrollment
 (submitted: June 30, 2015)
2100
Actual Study Completion DateDecember 11, 2017
Actual Primary Completion DateDecember 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of RA, axSpA, PsA or PsO
  • No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.

Exclusion Criteria:

  • The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
  • The additional documentation of the patient in another post-marketing study with etanercept is not permitted.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02486302
Other Study ID NumbersB1801385
ADEQUATE ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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