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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:


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
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, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014