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A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

Description

Brief Summary
The purpose of this registry is to collect additional information regarding the side effects and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). Information will be collected on serious events that are not that common or may only be seen with long-term treatment. These events include death, cancers, serious infections and other infections of interest, and serious mental health problems. Information on the effectiveness of BENLYSTA will also be collected.


Detailed Description
The registry will enroll 2 groups of patients. One group will include patients who are currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA). For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all patients will continue to be followed regardless of changes in their lupus medicines until study completion. Physicians will manage the patient in accordance with their medical judgment and standard of care. Data will be collected at enrollment and at 6 month intervals for 5 years.

Phase

N/A

Inclusion and Exclusion Criteria

  • Clinical diagnosis of active SLE.
  • Autoantibody-positive.
  • Current SLE treatment includes BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics). Key

  • Have received treatment with an investigational agent within the past year.
  • Are currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation trial in which belimumab is used as an investigational agent.
  • Have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
  • Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine) or only steroids.

Sites

  • California

    • GSK Investigational Site, Glendale, California, 91204
    • GSK Investigational Site, Los Angeles, California, 90048
    • GSK Investigational Site, Covina, California, 91723
    • GSK Investigational Site, West Hills, California, 91307
    • GSK Investigational Site, Upland, California, 91786
    • GSK Investigational Site, Thousand Oaks, California, 91360
    • GSK Investigational Site, Murrieta, California, 92563
    • GSK Investigational Site, Bakersfield, California, 93301
    • GSK Investigational Site, San Diego, California, 92108
    • GSK Investigational Site, La Mesa, California, 92020
  • Arizona

    • GSK Investigational Site, Goodyear, Arizona, 85395
    • GSK Investigational Site, Phoenix, Arizona, 85032
    • GSK Investigational Site, Tucson, Arizona, 85712
  • Idaho

    • GSK Investigational Site, Meridian, Idaho, 83642
  • Oklahoma

    • GSK Investigational Site, Oklahoma City, Oklahoma, 73103
    • GSK Investigational Site, Oklahoma City, Oklahoma, 73104
    • GSK Investigational Site, Edmond, Oklahoma, 73013
  • Texas

    • GSK Investigational Site, Austin, Texas, 78758
    • GSK Investigational Site, Waco, Texas, 76708
    • GSK Investigational Site, Plano, Texas, 75023
    • GSK Investigational Site, Houston, Texas, 77062
  • Louisiana

    • GSK Investigational Site, Lake Charles, Louisiana, 70601
  • Missouri

    • GSK Investigational Site, St. Louis, Missouri, 63110
  • Illinois

    • GSK Investigational Site, Morton Grove, Illinois, 60053
    • GSK Investigational Site, Chicago, Illinois, 60612
  • Indiana

    • GSK Investigational Site, South Bend, Indiana, 46601
  • Michigan

    • GSK Investigational Site, Lansing, Michigan, 48917
  • Georgia

    • GSK Investigational Site, Marietta, Georgia, 30060
  • France

    • GSK Investigational Site, Bondy, 93140
    • GSK Investigational Site, Lille cedex, 59037
    • GSK Investigational Site, Paris, 75013
  • Slovakia

    • GSK Investigational Site, Banksa Bystrica, 97401
  • Baden-Wuerttemberg

    • GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, 69121
  • Hessen

    • GSK Investigational Site, Bad Nauheim, Hessen, 61231
Presentado por SC CTSI