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

NCT00678782 | Completed Phase 2 DMC

• 1 other identifier: E-IA-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Knee Joint Synovitis

Keywords

knee; synovitis; arthritis; rheumatoid arthritis; psoriatic arthritis; spondyloarthropathies; intraarticular; etanercept

Outcome Measures

Primary Outcomes (1)

• Thompson articular index

  2 weeks

Secondary Outcomes (1)

• Knee Joint Articular Index

  2 weeks

Interventions

etanercept DRUG

etanercept 12.5mg, intraarticular injection administered once every two weeks for an eight week period

Also known as: Enbrel

placebo DRUG

Placebo (NaCl) 0.5 ml intraarticular injection

Also known as: NaCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Padova: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator
• Azienda Ospedaliera di Padova: collaborator

Study Sites (1)

Centro Multidisciplinare di Day Surgery, Azienda Ospedaliera di Padova, Ospedale Busonera, via Gattamelata 64

Padua, 35128, Italy

Location

Related Publications (2)

• Fiocco U, Sfriso P, Oliviero F, Lunardi F, Calabrese F, Scagliori E, Cozzi L, Di Maggio A, Nardacchione R, Molena B, Felicetti M, Gazzola K, Stramare R, Rubaltelli L, Accordi B, Costa L, Roux-Lombard P, Punzi L, Dayer JM. Blockade of intra-articular TNF in peripheral spondyloarthritis: its relevance to clinical scores, quantitative imaging and synovial fluid and synovial tissue biomarkers. Joint Bone Spine. 2013 Mar;80(2):165-70. doi: 10.1016/j.jbspin.2012.06.016. Epub 2012 Aug 3.

  PMID: 22867975 DERIVED

• Fiocco U, Oliviero F, Sfriso P, Calabrese F, Lunardi F, Scagliori E, Rubaltelli L, Stramare R, Di Maggio A, Nardacchione R, Cozzi L, Molena B, Felicetti M, Gazzola K, Lo Nigro A, Accordi B, Roux-Lombard P, Dayer JM, Punzi L. Synovial biomarkers in psoriatic arthritis. J Rheumatol Suppl. 2012 Jul;89:61-4. doi: 10.3899/jrheum.120246.

  PMID: 22751595 DERIVED

MeSH Terms

Conditions

Synovitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Ugo Fiocco, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

IT (1)