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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00657189 |
The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.
Condition | Intervention | Phase |
---|---|---|
Lupus |
Drug: MEDI-545 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus |
Estimated Enrollment: | 80 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MEDI-545
|
Drug: MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
|
2: Experimental
MEDI-545
|
Drug: MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
|
3: Experimental
MEDI-545
|
Drug: MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
|
4: Experimental
MEDI-545
|
Drug: MEDI-545
100 mg every week × 13 doses
|
5: Placebo Comparator
Placebo
|
Drug: Placebo
SC Placebo every week × 13 doses
|
The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Have received the following medications within 28 days before randomization:
Have received fluctuating doses of the following within 28 days before randomization:
At screening blood tests (within 28 days before randomization), any of the following:
Contact: Mick Ribeiro | 301-398-0000 | ribeirom@medimmune.com |
Contact: Helene Mortimer | 301-398-0000 | mortimerh@medimmune.com |
United States, Alabama | |
Pinnacle Research Group, LLC | Recruiting |
Anniston, Alabama, United States, 36207 | |
Contact: Monique Welch 256-236-0055 willmonique@bellsouth.net | |
Principal Investigator: Vishala Chindalore, MD | |
United States, California | |
Talbert Medical Group | Recruiting |
Huntington Beach, California, United States, 92646 | |
Contact: Teresa Falcon 714-968-0068 teresa.falcon@talbertmedical.com | |
Principal Investigator: Wesley T. Mizutani, MD | |
United States, Connecticut | |
University of Connecticut Health Center Division of Rheumatology | Not yet recruiting |
Farmington, Connecticut, United States, 06030-5353 | |
Contact: Kim Schwartz 860-679-2589 kschwartz@uchc.edu | |
Principal Investigator: Naomi Rothfield, MD | |
United States, Florida | |
Clinical Research of West Florida, Inc. | Recruiting |
Clearwater, Florida, United States, 33765-2616 | |
Contact: Lynn Merriam 727-466-0078 lmerriam@crwf.com | |
Principal Investigator: Robert Levin, MD | |
Ocala Rheumatology Research Center | Not yet recruiting |
Ocala, Florida, United States, 34474 | |
Contact: Tracey Langley 352-861-6931 | |
Principal Investigator: Stephen Bookbinder, M.D. | |
United States, Georgia | |
Marrietta Rheumatology | Not yet recruiting |
Marietta, Georgia, United States, 30060 | |
Contact: Nancy Green 770-205-6144 ngreen@csi-research.com | |
Principal Investigator: Mohammed Abubaker, M.D. | |
Not yet recruiting | |
Decatur, Georgia, United States, 30033 | |
Contact: Dena Hatzp 1-404-296-4911 | |
Principal Investigator: Jefrey Lieberman, MD | |
Emory Univ., Div. of Rheumatology | Not yet recruiting |
Atlanta, Georgia, United States, 30303 | |
Contact: Karla Caylor 404-616-7553 | |
Principal Investigator: S. Sam Limm, M.D. | |
United States, Indiana | |
Tri-State Arthritis & Rheumatology Research, LLC | Recruiting |
Evansville, Indiana, United States, 47714 | |
Contact: Pamela Dorsey, LPN 812-437-2330 pedorsey@sigecom.net | |
Principal Investigator: Moges Sisay, MD | |
United States, Maryland | |
The Johns Hopkins University Rheumatology Faculty Practice School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Merriam Eljanne, PhD 410-614-1574 meljann1@jhmi.edu | |
Principal Investigator: Michelle Petri, MD | |
United States, New Jersey | |
Fisher Clinical Research | Not yet recruiting |
Haddon Heights, New Jersey, United States, 08035 | |
Contact: Crystal Behm 856-547-8004 crystal@markfishermd.com | |
Principal Investigator: Mark Fisher, MD | |
United States, North Carolina | |
Carolina Bone & Joint P.A. | Recruiting |
Charlotte, North Carolina, United States, 28210 | |
Contact: Laura Crawford 704-541-3055 ext 239 ccrawford@bonesrus.org | |
Principal Investigator: Jane Box, MD | |
United States, Ohio | |
Cincinnati Rheumatic Disease Study Group, Inc. | Not yet recruiting |
Cincinnati, Ohio, United States, 45219 | |
Contact: Laurie Alexander 513-558-5538 | |
Principal Investigator: Michael Luggen, M.D. | |
United States, Oklahoma | |
Oklahoma Medical Research Foundation | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Fredonna Carthen 405-271-8000 ext 34808 fredonna-carthen@omrf.ouhsc.edu | |
Principal Investigator: Joan T. Merrill, MD | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | Recruiting |
Duncansville, Pennsylvania, United States, 16635 | |
Contact: Brenda Earnest 814-693-0030 Brendaearnest1125@yahoo.com | |
Principal Investigator: Alan Kivitz, MD | |
United States, Texas | |
Texas Research Center | Not yet recruiting |
Sugarland, Texas, United States, 77479 | |
Contact: Darlynne Sanchez 281-980-8135 dsanchez@texasresearchmd.net | |
Principal Investigator: Angela McCain, MD |
Study Director: | Dominique Ethgen, M.D. | MedImmune LLC |
Responsible Party: | MedImmune LLC ( Dominique Ethgen, M.D. ) |
Study ID Numbers: | MI-CP179 |
Study First Received: | April 9, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00657189 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Interferon-alpha Antibodies Autoimmune Diseases Lupus Erythematosus, Systemic |
Interferons Connective Tissue Diseases Interferon Alfa-2a Immunoglobulins |
Immune System Diseases |