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

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ClinicalTrials.gov Identifier: NCT00522184
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : August 29, 2007
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Centre Hospitalier Universitaire de Nice

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 Type : Interventional  (Clinical Trial)
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 : February 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

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



Primary Outcome Measures :
  1. Pain [ Time Frame: every month during six month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522184


Locations
France
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

ClinicalTrials.gov Identifier: NCT00522184     History of Changes
Other Study ID Numbers: 02-PP-04
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007

Keywords provided by Centre Hospitalier Universitaire de Nice:
intra-articular injection
acute synovitis
etanercept

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors