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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:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00522184
First received: August 27, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Etanercept
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00522184     History of Changes
Other Study ID Numbers: 02-PP-04
Study First Received: August 27, 2007
Last Updated: August 27, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Synovitis
Stress, Psychological
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Behavioral Symptoms
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013