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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Collaborators: Azienda Ospedaliera di Padova; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept

Criteria

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
• 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.