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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

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NCT02378506

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
MHAT Plovdiv
Plovdiv, , 4000 Bulgaria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
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

- Moderate to severe active disease with presence of at least 4 tender joints and 4
swollen joints.

- Either the patient or a designee must be capable of administering the subcutaneous
injection of study drug.

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

- Prior treatment with etanercept.

- Presence of active infection or active or untreated tuberculosis.

NCT02378506
Pfizer
Completed
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis, Rheumatoid
Biological: etanercept
50mg subcutaneous, once weekly, 24 weeks
Experimental: ETN 50mg QW
Intervention: Biological: etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
June 2016
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
  • Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

  • Prior treatment with etanercept.
  • Presence of active infection or active or untreated tuberculosis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Croatia,   Germany,   Greece,   Hungary,   Poland,   Serbia,   Slovakia,   South Africa
Russian Federation
 
NCT02378506
B1801359
2013-004569-16 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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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[email protected]



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