Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Genentech |
---|---|
Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00541749 |
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: rhuMAb IFNalpha |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Jorn Drappa, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | IFN3958g |
Study First Received: | October 7, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00541749 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SLE |
Interferon-alpha Anti-Infective Agents Autoimmune Diseases Immunologic Factors Lupus Erythematosus, Systemic |
Lupus Interferons Connective Tissue Diseases Interferon Alfa-2a Antiviral Agents |
Interferon-alpha Anti-Infective Agents Autoimmune Diseases Immunologic Factors Immune System Diseases Lupus Erythematosus, Systemic |
Therapeutic Uses Physiological Effects of Drugs Connective Tissue Diseases Antiviral Agents Pharmacologic Actions |