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A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

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NCT00484237

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Goshogawara, Aomori, 037-0053 Japan
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.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Presence of >6 swollen joints and >6 tender joints

- Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)

- Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

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

- Previous treatment with etanercept, antibody to TNF?, or other TNF? inhibitors

- Received investigational drugs within 6 months of the baseline visit

- Received intra-articular hyaluronic acid injections within 4 weeks of the baseline
visit

NCT00484237
Pfizer
Completed
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

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A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: etanercept
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
80
December 2007
Not Provided

Inclusion Criteria:

  • Presence of >6 swollen joints and >6 tender joints
  • Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
  • Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

  • Previous treatment with etanercept, antibody to TNF?, or other TNF? inhibitors
  • Received investigational drugs within 6 months of the baseline visit
  • Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00484237
0881A1-3324
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
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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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