Etanercept SFP in RA Patients

NCT00413452

Last updated date
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1-800-718-1021

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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

- Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA

- Naïve to etanercept therapy

- Able to self-inject investigational product or have a designee who can do so

- Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained

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


- Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days
befor 1st dose of investigational product


- Receipt of MTX witin 30 days of 1st dose of investigational product


- Receipt of an other investigational drug within 30 days of 1st dose


- Receipt of TNF inhibitor therapy within 90 days of 1st dose


- Receipt of cyclophosphamide within 6 mo of 1st dose


- Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum
recommended dose in the product info sheet


- Current use of insulin


- gnificant concurrent medical condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE Etanercept SFP in RA Patients
Official Title  ICMJE Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.
Brief Summary Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Etanercept
50 mg once weekly
Study Arms  ICMJE Experimental: 50 mg
50 mg once weekly
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 Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2008)
224
Original Enrollment  ICMJE
 (submitted: December 15, 2006)
200
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
  • Naïve to etanercept therapy
  • Able to self-inject investigational product or have a designee who can do so
  • Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria
  • Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
  • Receipt of MTX witin 30 days of 1st dose of investigational product
  • Receipt of an other investigational drug within 30 days of 1st dose
  • Receipt of TNF inhibitor therapy within 90 days of 1st dose
  • Receipt of cyclophosphamide within 6 mo of 1st dose
  • Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
  • Current use of insulin
  • gnificant concurrent medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00413452
Other Study ID Numbers  ICMJE 20060104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP