Back to resultsA Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
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 TNFα, or other TNFα inhibitors
- Received investigational drugs within 6 months of the baseline visit
- Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Sites / Locations
Outcomes
Primary Outcome Measures
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
Secondary Outcome Measures
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
Full Information
NCT ID
NCT00484237
First Posted
June 7, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00484237
Brief Title
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
etanercept
Primary Outcome Measure Information:
Title
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
Secondary Outcome Measure Information:
Title
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 TNFα, or other TNFα inhibitors
Received investigational drugs within 6 months of the baseline visit
Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Goshogawara
State/Province
Aomori
ZIP/Postal Code
037-0053
Country
Japan
City
Choseigun
State/Province
Chiba
ZIP/Postal Code
299-4301
Country
Japan
City
Yotsukaido
State/Province
Chiba
ZIP/Postal Code
284-0003
Country
Japan
City
Fukushima City
State/Province
Fukushima
ZIP/Postal Code
960-8251
Country
Japan
City
Higashihiroshima
State/Province
Hiroshima
ZIP/Postal Code
790-0002
Country
Japan
City
Katoh
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
City
Sendai-City
State/Province
Miyagi
ZIP/Postal Code
982-0032
Country
Japan
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
City
Nagano
ZIP/Postal Code
380-0928
Country
Japan
City
Oita
ZIP/Postal Code
870-0823
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
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