Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

NCT00913458

Last updated date
Study Location
Pfizer Investigational Site
Lyon, , 69437, France
Contact
1-800-718-1021

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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.

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Active Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid ArthritisStudy Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis NCT00913458
  1. Lyon,
  2. Montpellier Cedex 05,
  3. Paris Cedex 13,
  4. Paris Cedex 14,
  5. Paris,
  6. Strasbourg Cedex,
  7. Toulouse Cedex 9,
  8. Vogelsang, Gommern
  9. Elmshorn,
  10. Halle,
  11. Halle,
  12. Hamburg-Altona,
  13. Hamburg,
  14. Ludwigsfelde,
  15. Muenchen,
  16. Osnabrueck,
  17. Rostock,
  18. Wuerzburg,
  19. Zerbst,
  20. Dublin,
  21. Pavia,
  22. Pisa,
  23. Monaco,
  24. Amsterdam, Noord Holland
  25. Haarlem,
  26. Heerlen,
  27. Bydgoszczy,
  28. Poznan,
  29. Torun,
  30. Ustron,
  31. Warsawa,
  32. Warszawa,
  33. Wroclaw,
  34. Zyrardow,
  35. Doha,
  36. Bucharest,
  37. Bucuresti,
  38. Bucuresti,
  39. Bucuresti,
  40. Bucuresti,
  41. Targu Mures,
  42. Yaroslavl,
  43. Oviedo, Asturias
  44. Barcelona,
  45. Barcelona,
  46. La Coruna,
  47. Madrid,
  48. Valencia,
  49. St. Gallen, SG
  50. Chur,
  51. Lausanne,
  52. Wigan, Lancaster
  53. Harrogate, North Yorkshire
  54. Dudley, West Midlands
  55. Leeds, West Yorkshire
  56. London,
  57. Manchester,
  58. Newcastle Upon Tyne,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.
Detailed Description Not 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 Date June 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014

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