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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 August 9, 2018

FOR MORE INFORMATION
Study Location
Private Practice Maltzahn
Goettingen, Niedersachsen, 37073 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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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.
A 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
The 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, psoriatic arthritis, axial spondyloarthritis, or plaque psoriasis. 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,
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Axial Spondyloarthritis
  • Plaque Psoriasis
Drug: Etanercept
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Observation Group
Intervention: Drug: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2100
December 21, 2017
December 21, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Germany
 
 
NCT02486302
B1801385
ADEQUATE ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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