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Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study

NCT ID: NCT00522184

Last Updated: 2007-08-29

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-11-30

Brief Summary

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Intra-articular injection of etanercept in patient suffering from rheumatoid arthritis: a double-blind randomized study for evaluation of efficacy and safety of etanercept versus intra-articular steroid injection in acute synovitis (knee,wrist,ankle,elbow)

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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intra-articular injection acute synovitis etanercept

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

patient receiving etanercept intra-articular injection

Group Type EXPERIMENTAL

intra-articular injection of etanercept

Intervention Type PROCEDURE

2

patient receiving steroid intra-articular injection

Group Type ACTIVE_COMPARATOR

intra-articular injection of steroid

Intervention Type PROCEDURE

Interventions

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intra-articular injection of etanercept

Intervention Type PROCEDURE

intra-articular injection of steroid

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* must be able to understand the information about the study
* diagnosis of rheumatoid arthritis for 6 month at least
* suffering for 2 weeks at least
* with evaluation of pain over 4/10
* with stable DMARDs treatment for three month at least

Exclusion Criteria

* infection or surgery on the target joint
* treated with infliximab,adalimumab or anakinra
Minimum Eligible Age

18 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 collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Principal Investigators

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Christian H ROUX

Role: PRINCIPAL_INVESTIGATOR

Rheumatology department, Nice

Locations

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Rheumatology department, Hopital Archet I

Nice, , France

Site Status

Countries

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France

Other Identifiers

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02-PP-04

Identifier Type: -

Identifier Source: org_study_id