NCT00522184

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

First QC Date

August 27, 2007

Last Update Submit

March 26, 2026

Conditions

Rheumatoid Arthritis

Keywords

intra-articular injectionacute synovitisetanercept

Outcome Measures

Primary Outcomes (1)

  • Pain

    every month during six month

Study Arms (2)

1

EXPERIMENTAL

patient receiving etanercept intra-articular injection

Procedure: intra-articular injection of etanercept

2

ACTIVE COMPARATOR

patient receiving steroid intra-articular injection

Procedure: intra-articular injection of steroid

Interventions

intra-articular injection of etanerceptPROCEDURE
1
intra-articular injection of steroidPROCEDURE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • infection or surgery on the target joint
  • treated with infliximab,adalimumab or anakinra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology department, Hopital Archet I

Nice, 06000, France

Location

Related Publications (1)

  • Roux CH, Breuil V, Valerio L, Amoretti N, Brocq O, Albert C, Grisot C, Allam Y, Chevalier P, Pradier C, Euller-Ziegler L. Etanercept compared to intraarticular corticosteroid injection in rheumatoid arthritis: double-blind, randomized pilot study. J Rheumatol. 2011 Jun;38(6):1009-11. doi: 10.3899/jrheum.100828. Epub 2011 Mar 16.

    PMID: 21406499RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christian H ROUX

    Rheumatology department, Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

February 1, 2005

Study Completion

November 1, 2006

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)