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Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Lyon, , 69437 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Rheumatoid Arthritis, Rheumatoid Arthritis, 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

- Diagnosis of early rheumatoid arthritis.

- Methotrexate (MTX) naive.

- Active early rheumatoid arthritis at the time of enrollment.

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

- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
inhibitors, or other biologic agents.

- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within
4 weeks before baseline.

- Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at
baseline.

NCT00913458
Pfizer
Completed
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

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Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
Official Title  ICMJE A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Brief SummaryStudy to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Active Rheumatoid Arthritis
  • Arthritis, Rheumatoid
  • Rheumatoid Arthritis
Intervention  ICMJE Drug: etanercept
Other Name: Enbrel
Study Arms  ICMJE Experimental: 1
etanercept + methotrexate; etanercept + methotrexate
Intervention: Drug: etanercept
Publications *


*   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: January 11, 2013)
306
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
300
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion DateJune 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of early rheumatoid arthritis.
  • Methotrexate (MTX) naive.
  • Active early rheumatoid arthritis at the time of enrollment.

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
  • Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
  • Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
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 France,   Germany,   Ireland,   Italy,   Monaco,   Netherlands,   Poland,   Qatar,   Romania,   Russian Federation,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913458
Other Study ID Numbers  ICMJE 0881X1-4524
B1801020
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2014

ICMJE     Data element required by the

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

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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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