Last updated on October 2016

Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cutaneous | Chronic Cutaneous | Lupus Erythematosus | Discoid
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other:
    Adults aged 18-80 years old.
    Have at least one active DLE lesion, either diagnosed by skin biopsy or confirmation
    by Dermatologist/ Rheumatologist.
    Patients with DLE only and SLE patients with DLE are included.
    Have refractory disease to an anti-malarial for at least 3 months as assessed by
    Patients receiving anti-malarials must have been receiving them for at least 3 months
    prior to Screening, with a stable dose regimen for at least 28 days (±1 day) prior to
    Baseline (the first study drug administration)
    Ability to provide an informed consent.
    All male and female patients biologically capable of having children must agree to
    use a reliable method of contraception for the duration of the study and for a period
    of 3 weeks after their final dose of study drug. Acceptable methods of contraception
    are surgical sterilisation, oral, implantable or injectable hormonal methods,
    intrauterine devices or barrier contraceptives.

You may not be eligible for this study if the following are true:

  • Any prior treatment with TNF-blockade therapies.
    Intramuscular or intra-dermal corticosteroid within 28 days of the Screening visit.
    Corticosteroid of greater than 10mg prednisolone daily equivalent, or change in oral
    teroid dose within 28 days prior to Baseline Visit.
    A change in the dose of other immunosuppressant including methotrexate, azathioprine
    and mycophenolate mofetil within 28 days (±1 day) prior to Baseline Visit.
    Concomitant therapies with any alkylating agents (e.g. cyclophosphamide,
    chlorambucil), other immunosuppressant including sulfasalazine and leflunomide, other
    biological agent particularly anakinra and abatacept and other experimental drug. If
    patients are on any of these, they need to be off therapies for at least 28 days
    prior to Baseline Visit to allow for washout.
    Evidence of an immunosuppressive state, including an active HIV infection,
    agammaglobulinaemias, T-cell deficiencies or Human T cell Lymphotrophic Virus Type 1
    Chronic active infection such as hepatitis B or hepatitis C and tuberculosis.
    Patients with latent tuberculosis may be included if treated with chemoprophylaxis
    for at least 2 months before starting the study and to continue chemoprophylaxis for
    a total of 6 months.
    History of cancer within the last 5 years except for squamous or basal cell skin
    carcinoma that has been completely excised and treated cervical carcinoma in situ.
    Demyelinating diseases.
    Moderate to severe heart failure based on New York Heart Association (NYHA)
    functional class III and IV.
    Planned surgery within the study period which is expected to require omission of
    tudy medication of 28 days or more.
    Receipt of live attenuated vaccine within 28 days prior to the Baseline Visit.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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