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Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

- Subjects who completed the previous double-blind,randomized study.

- Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who
can do so.

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

- Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before
week 0 evaluation.

- Clinically relevant concurrent medical events including: uncompensated congestive
heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating
diseases, presence or history of confirmed blood dyscrasias, cancer or history of
cancer, serious infection within 1 month of test article administration or active
infection at week 0.

NCT00252668
Pfizer
Completed
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

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Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Etanercept
  • Drug: Methotrexate
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2005
Not Provided

Inclusion Criteria:

  • Subjects who completed the previous double-blind,randomized study.
  • Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.

Exclusion Criteria:

  • Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.
  • Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00252668
0881A1-101631
B1801221
0881A1-400
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Sweden, Denmark and Norway, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Greece, [email protected]
Principal Investigator: Trial Manager For Czech Republic, [email protected]
Principal Investigator: Trial Manager For Romania, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Spain, Italy, Portugal, the Netherlands, and Finland, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2011

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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