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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

intra-articular injection of etanercept

intra-articular injection of steroid

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring intra-articular injection, acute synovitis, etanercept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rheumatology department, Hopital Archet I

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patient receiving etanercept intra-articular injection

patient receiving steroid intra-articular injection

Outcomes

Primary Outcome Measures

Pain

Secondary Outcome Measures

Full Information

NCT ID

NCT00522184

First Posted

August 27, 2007

Last Updated

August 27, 2007

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00522184

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

intra-articular injection, acute synovitis, etanercept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patient receiving etanercept intra-articular injection

Arm Title

Arm Type

Active Comparator

Arm Description

patient receiving steroid intra-articular injection

Intervention Type

Procedure

Intervention Name(s)

intra-articular injection of etanercept

Intervention Type

Procedure

Intervention Name(s)

intra-articular injection of steroid

Primary Outcome Measure Information:

Title

Pain

Time Frame

every month during six month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian H ROUX

Organizational Affiliation

Rheumatology department, Nice

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rheumatology department, Hopital Archet I

City

Nice

ZIP/Postal Code

06000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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