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Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

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NCT00913458

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Lyon, , 69437 France
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.
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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Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate
Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Active Rheumatoid Arthritis
  • Arthritis, Rheumatoid
  • Rheumatoid Arthritis
Drug: etanercept
Other Name: Enbrel
Experimental: 1
etanercept + methotrexate; etanercept + methotrexate
Intervention: Drug: etanercept


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
December 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Ireland,   Italy,   Monaco,   Netherlands,   Poland,   Qatar,   Romania,   Russian Federation,   Spain,   Switzerland,   United Kingdom
 
 
NCT00913458
0881X1-4524
B1801020
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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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