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Evaluation of The Efficacy And Safety of Intra-Articular Etanercept in Patients With Refractory Knee Joint Synovitis

This study has been completed.
Wyeth is now a wholly owned subsidiary of Pfizer
Azienda Ospedaliera di Padova
Information provided by:
University of Padova Identifier:
First received: May 14, 2008
Last updated: May 15, 2008
Last verified: May 2008
To assess the therapeutic efficacy, of the clinical response of intraarticular (IA) etanercept (E) 12.5 mg or placebo (P: NaCl) injections into single knee arthritic joint of patients with refractory knee joint synovitis (KJS), administered once every two week, for eight weeks, with cross over after 2 weeks, in two groups of randomly assigned patients, for whom traditional systemic disease-modifying antirheumatic drugs (DMARDs) is insufficient or inappropriate. The primary outcome measure is the Thompson articular index of KJS disease activity.

Condition Intervention Phase
Persistent Knee Joint Synovitis Drug: etanercept Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of The Efficacy And Safety of Intra-Articular Etanercept in Patients With Refractory Knee Joint Synovitis: a Placebo Controlled, Single-Blind, Crossover-Trial, With Randomisation of Treatment Sequence

Resource links provided by NLM:

Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Thompson articular index [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Knee Joint Articular Index [ Time Frame: 2 weeks ]

Enrollment: 31
Study Start Date: April 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: etanercept
    etanercept 12.5mg, intraarticular injection administered once every two weeks for an eight week period
    Other Name: Enbrel
    Drug: placebo
    Placebo (NaCl) 0.5 ml intraarticular injection
    Other Name: NaCl
  Show Detailed Description


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

Inclusion Criteria:

  • Male or female patients 18 years of age or older and of legal age of consent.
  • A negative serum pregnancy test at screening and use of a medically acceptable form of contraception starting at screening and continuing throughout the study, is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).
  • Meet the 1987 American Rheumatism Association (ARA) revised criteria for Rheumatoid Arthritis(RA) and generally accepted criteria for psoriatic (PsA) or spondyloarthritides (SpA).
  • Meet the following criteria at both the screening visit and the baseline visit:

    • Refractory KJS defined by the presence of: Persistence of active synovitis of the knee (characterized by pain, tenderness and effusion), which had proved resistant to at least 6 months second-line DMARD therapy
    • Failure drug therapy with at least one DMARD and/or anti-TNFα biologic agent, and/or systemic or IA corticosteroid treatment. (Drug failure is defined as a drug discontinuation because of lack of clinical efficacy or intolerable adverse effects).
  • Normal chest X-ray as clinically indicated.
  • Provide written informed consent.
  • In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.

Exclusion Criteria:

  • Uncooperative patients with a history of poor compliance.
  • Known hypersensitivity to etanercept or any of its components.
  • Known significant concurrent medical disease including:

    • cancer or history of cancer (other than resected basal cell carcinoma of the skin)
    • congestive heart failure
    • myocardial infarction within 12 months of the screening visit
    • uncontrolled angina pectoris
    • active infection
    • sepsis or at risk of sepsis
    • severe pulmonary disease
    • known HIV infection
    • liver function abnormality (SGOT/AST, SGPT/ALT: greater than two times the upper limit of normal); liver cirrhosis or fibrosis
    • renal disease (creatinine level >175umol/L)
    • leukopenia (white blood cells <3.5 x 109/L)
    • thrombocytopenia (<1.25 x 1011/L)
    • haemoglobin </= 8.5 g/dL
  • Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient.
  • Use of any investigational drug within four weeks of the screening visit.
  • In the opinion of the investigator, the patient shows persistent signs of immunosuppression.
  • Receipt of any live attenuated vaccine within eight weeks before the screening visit.
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Please refer to this study by its identifier: NCT00678782

Centro Multidisciplinare di Day Surgery, Azienda Ospedaliera di Padova, Ospedale Busonera, via Gattamelata 64
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Wyeth is now a wholly owned subsidiary of Pfizer
Azienda Ospedaliera di Padova
Principal Investigator: Ugo Fiocco, MD, PhD University of Padova
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Ugo Fiocco, Centro Multidisciplinare di Day Surgery, Azienda Ospedaliera di Padova Identifier: NCT00678782     History of Changes
Other Study ID Numbers: E-IA-02
Study First Received: May 14, 2008
Last Updated: May 15, 2008

Keywords provided by University of Padova:
rheumatoid arthritis
psoriatic arthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors processed this record on September 21, 2017