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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522184
• Other study ID #: 02-PP-04
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2007
• Last updated: August 27, 2007
• Start date: February 2005
• Est. completion date: November 2006

Study information

• Verified date: August 2007
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• intra-articular injection of etanercept

• intra-articular injection of steroid

Locations

Country	Name	City	State
France	Rheumatology department, Hopital Archet I	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		every month during six month