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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT00522184
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 1.6

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Procedure: intra-articular injection of etanercept; Procedure: intra-articular injection of steroid	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2005
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 patient receiving etanercept intra-articular injection	Procedure: intra-articular injection of etanercept
Active Comparator: 2 patient receiving steroid intra-articular injection	Procedure: intra-articular injection of steroid

Outcome Measures

Primary Outcome Measures

1. Pain [every month during six month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology department, Hopital Archet I	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice
• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Christian H ROUX, Rheumatology department, Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00522184
• Other Study ID Numbers: 02-PP-04
• First Posted: Aug 29, 2007
• Last Update Posted: Aug 29, 2007
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: intra-articular injection; acute synovitis; etanercept
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Etanercept

Study Results

No Results Posted as of Aug 29, 2007