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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | Facet Biotech |
ClinicalTrials.gov Identifier: | NCT00109161 |
This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis |
Estimated Enrollment: | 270 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | October 2006 |
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Abnormal hematology, as defined by the following laboratory values: *Hemoglobin ≤8.5 g/dL, *Lymphocytes
Use of any of the following: *Any of the following types of live virus vaccine from 4 weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines, however, by household contacts does not affect the eligibility of patients to enroll or continue in the study; *Systemic corticosteroids, adrenocorticotropic hormone, or plasma exchange within 4 weeks before the baseline MRI scan (no more than 72 hours before Day 0); *Azathioprine, mycophenolate mofetil, methotrexate, glatiramer acetate, or intravenous immune globulin within 6 months before randomization; *An immunomodulatory agent within 6 months before randomization, except for interferon-beta products required per protocol; *An investigational agent within 6 months before randomization unless this agent is non-immunomodulatory and the medical monitor or steering committee rules that its use is acceptable on the theoretical basis of a lapse of at least 5 serum half-lives since administration of the last possible dose;
Principal Investigator: | Richard Dickson, M.D. | Wenatchee Valley Medical Center |
Principal Investigator: | Steven Pugh, M.D. | Rockwood Clinic, PS |
Principal Investigator: | Daniel Wynn, M.D. | Consultants in Neurology |
Principal Investigator: | Theodore J. Phillips, M.D. | The MS Center at Texas Neurology |
Principal Investigator: | Joanna Cooper | Sutter East Bay Medical Foundation |
Principal Investigator: | James R. Storey | Upstate Clinical Research |
Principal Investigator: | Malcolm Gottesman, M.D. | Winthrop University Hospital |
Principal Investigator: | Herman Sullivan, M.D. | Michigan Medical P.C. Neurology |
Principal Investigator: | Timothy Vollmer, M.D. | St. Joseph's Hospital and Medical Center, Phoenix |
Principal Investigator: | Jeffery Dunn, M.D. | MS Hub Medical Group |
Principal Investigator: | S. Mitchell Freedman, M.D. | Raleigh Neurology Associates |
Principal Investigator: | Joseph Herbert, M.D. | Hospital for Joint Diseases, MS Care Center |
Principal Investigator: | Omar Khan, M.D. | Wayne State University MS Center |
Principal Investigator: | Marcelo Kremenchutzky, M.D. | London Health Sciences Centre |
Principal Investigator: | Sharon Lynch, M.D. | CLMC Neurology |
Principal Investigator: | Alireza Minagar, M.D. | Louisiana State University Health Sciences Center |
Principal Investigator: | Jeffrey English, M.D. | The Multiple Sclerosis Center of Atlanta |
Principal Investigator: | Andrew Goodman, M.D. | University of Rochester |
Principal Investigator: | Michael Kaufman, M.D. | MS Center/CMC |
Principal Investigator: | Florian P. Thomas, M.D. | St. Louis University Hospital |
Principal Investigator: | Clyde Markowitz, M.D. | University of Pennsylvania |
Principal Investigator: | Jayne Martin, M.D. | Michigan State University |
Principal Investigator: | Maria Melanson, M.D. | Health Sciences Center |
Principal Investigator: | MaryAnn Picone, M.D. | Gimble MS Center |
Principal Investigator: | Christopher Bever, M.D | Maryland Center for MS |
Principal Investigator: | Gregg G. Blevins, M.D. | University of Alberta |
Principal Investigator: | Kasper Lloyd, M.D. | MS Center at Dartmouth |
Principal Investigator: | Yves Lapierrre, M.D. | Montreal Neurological Institute |
Principal Investigator: | John W. Rose, M.D. | University of Utah CAMT |
Principal Investigator: | Michael Yeung, M.D. | Foothills Medical Centre |
Principal Investigator: | Neil Lava, M.D. | Albany Medical College |
Principal Investigator: | Jonathan L. Carter, M.D. | Mayo Clinic |
Principal Investigator: | Francois Jacques, M.D. | Clinique SEP/NM |
Principal Investigator: | William Honeycutt, M.D. | Neurology Associates, P.A. |
Principal Investigator: | Istvan Pirko, M.D. | University of Cincinnati |
Principal Investigator: | Ed Fox, M.D. | Central Texas Neurology |
Study ID Numbers: | DAC-1012 |
Study First Received: | April 22, 2005 |
Last Updated: | August 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00109161 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis, MS, CNS, Daclizumab |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases |
Daclizumab Demyelinating Autoimmune Diseases, CNS Sclerosis Immunosuppressive Agents Autoimmune Diseases of the Nervous System Immunoglobulins |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Daclizumab Nervous System Diseases Physiological Effects of Drugs Sclerosis |
Immunosuppressive Agents Pharmacologic Actions Antibodies, Monoclonal Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |