An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Status: | Recruiting |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 76 |
Updated: | 4/6/2019 |
Start Date: | January 9, 2018 |
End Date: | April 9, 2020 |
Contact: | Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term
safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who
have completed Study GA30044 (NCT02908100) up to 48 weeks.
safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who
have completed Study GA30044 (NCT02908100) up to 48 weeks.
Inclusion Criteria:
- Able to comply with the study protocol, in the investigator's judgment
- Completion of Study GA30044 up to 48 weeks
- Acceptable safety and tolerability during Study GA30044 as determined by the
investigator
Exclusion Criteria:
- Met protocol-defined treatment-stopping criteria during Study GA30044
- An adverse event in Study GA30044 that required permanent discontinuation of study
drug
- In the opinion of the investigator, any new, significant, uncontrolled comorbidity or
new clinical manifestation (related to SLE or not) that requires medications not
allowed in this protocol; or could put the participant at undue risk from a safety
perspective
- Any uncontrolled or clinically significant laboratory abnormality that would affect
safety, interpretation of study data, or the participant's participation in the study
in the opinion of the investigator in consultation with the Medical Monitor
We found this trial at
27
sites
New York University School of Medicine NYU School of Medicine has a proud history that...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Manhasset, New York 11031
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