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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522184
First Posted: August 29, 2007
Last Update Posted: August 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Centre Hospitalier Universitaire de Nice
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Procedure: intra-articular injection of etanercept Procedure: intra-articular injection of steroid Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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

Enrollment: 34
Study Start Date: February 2005
Study Completion Date: November 2006
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00522184     History of Changes
Other Study ID Numbers: 02-PP-04
First Submitted: August 27, 2007
First Posted: August 29, 2007
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


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