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AbbVie M23-699 (SELECT SLE)

Lupus

To see if adding study drug to background SLE medications improves SLE. 

Study 1 & 2 are identical but run separately.

Study 1 (500 ptps) - 52 weeks - receive active study drug or fake drug.

Study 2 (500 ptps) - 52 weeks - receive active study drug or fake drug.

Study 3 - 52 weeks extension (receive real drug but are randomly re-assigned to 15 mg or 30 mg once a day.

One safety follow-up visit, or phone call if a visit is not possible, 30 days after the last dose of study drug.

The study drug is a pill, taken once a day by mouth.

Assessments include lupus assessments by the study doctor, blood and urine tests, heart tracing (ECG), questionnaires that ask about lupus and how it affects quality of life.

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Conditions de participation

  • Sexe:

    Any

  • Âges admissibles:

    18 to 63

Critères de participation

Inclusion Criteria:
Lupus for at least 24 weeks.

On stable background SLE medications at least 60 days before baseline visit, with stable doses at least 14 days before baseline visit (permitted medications are dictated by the protocol).
Exclusion Criteria:
Cannot be pregnant or breastfeeding during the study or for 30 days after last dose of study drug.
History of two or more episodes of shingles.
HIV positive, active Hepatitis or Active Tuberculosis.
Stroke, heart attack, cardia stenting or bypass surgery, or a blood clot within the last 6 months.
Organ transplant.
Past gastric bypass surgery (gastric banding IS permitted).
History of cancer (except basal or squamous cell skin cancer, or cancer of the cervix - if it has been treated/cured.

Lieu de l'étude

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Edna Hutchings

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780-492-8290
Étude parrainée par
University of Alberta
Participants recherchés
Plus d'informations
ID de l'étude: Pro00139308