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

NCT ID: NCT00484237

Last Updated: 2007-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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etanercept

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Goshogawara, Aomori, Japan

Site Status

Choseigun, Chiba, Japan

Site Status

Yotsukaidō, Chiba, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Fukushima, Fukushima, Japan

Site Status

Higashihiroshima, Hiroshima, Japan

Site Status

Katoh, Hyōgo, Japan

Site Status

Sagamihara, Kanagawa, Japan

Site Status

Kumamoto, Kumamoto, Japan

Site Status

Sendai, Miyagi, Japan

Site Status

Nagano, Nagano, Japan

Site Status

Sasebo, Nagasaki, Japan

Site Status

Ōita, Oita Prefecture, Japan

Site Status

Countries

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Japan

Other Identifiers

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0881A1-3324

Identifier Type: -

Identifier Source: org_study_id