Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
NCT ID: NCT00109161
Last Updated: 2008-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2005-04-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of MS by McDonald criteria.
* EDSS \<7.0.
* On stable IFN-beta regimen for at least 6 months.
* The occurrence of either of the following within 9 months prior to screening: ≥1 MS relapse OR A qualifying MRI, defined as an MRI that showed at least one confirmed Gd-CEL of the brain or spinal cord, was performed independently of the study while the patient was on a stable IFN-beta regimen, and is deemed acceptable by the central reader.
* For females, women of non-childbearing potential or women of childbearing potential who provide a negative serum pregnancy test at screen and within 24 hours of first dose of study drug, and who agree to use effective contraception during the Treatment and Follow-up periods of the study.
* Willing and able to comply with the protocol, provision of informed consent in accordance with institutional and regulatory guidelines, and, for US sites only, authorization to use protected health information.
Exclusion Criteria
* Non-ambulatory patient.
* Clinically significant abnormality on screening ECG.
* Malignancy within the past 5 years, except for adequately treated non-melanoma skin carcinoma or in situ carcinoma of the cervix.
* History of HIV infection, positive serology for HBV (hepatitis B virus) or HCV (hepatitis C virus).
* Varicella (VZV) or herpes zoster virus infection, or any severe viral infection, within 6 weeks before screening or exposure to VZV within 21 days of screening.
* Abnormal hematology, as defined by the following laboratory values: \*Hemoglobin ≤8.5 g/dL, \*Lymphocytes ≤1.0 x 10\^9/L, \*Platelets ≤100 x 10\^9/L, \*Neutrophils ≤1.5 x 10\^9/L.
* Significant organ dysfunction, including but not limited to cardiac, renal, liver, non-MS related CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic dysfunction, or other disease or condition, which in the opinion of the PI (principal investigator) would make the patient an unsuitable candidate for the study. Guidelines for levels of unacceptable dysfunction include: \*creatinine ≥1.6 mg/dL; \*AST and ALT ≥2.5 times upper limit of normal (ULN); \*alkaline phosphatase ≥2.5 times ULN; \*history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to randomization.
* 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; \*A monoclonal antibody (eg, Rituxan®/ Rituximab) within 6 months before randomization; \*Daclizumab at any time prior to randomization; \*Cladribine, mitoxantrone, cyclophosphamide, CamPath® (alemtuzumab), natalizumab (TYSABRI®/Antegren) or other drugs targeting alpha 4 integrin, total lymphoid irradiation, or bone marrow transplant at any time
* Patients for whom MRI is contraindicated, ie, have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed.
* Primary progressive MS.
* Clinically unstable for 30 days before randomization (Patients who experienced a relapse, with or without steroid treatment, during the screening period may be re-screened after 30 days.)
* Elective surgery performed from 2 weeks prior to randomization or scheduled through Week 44
* Infection (viral, fungal, bacterial) requiring hospitalization or IV antibiotics within 8 weeks before randomization.
18 Years
55 Years
ALL
No
Sponsors
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PDL BioPharma, Inc.
INDUSTRY
Principal Investigators
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Richard Dickson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wenatchee Valley Medical Center
Steven Pugh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rockwood Clinic, PS
Daniel Wynn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Consultants in Neurology
Theodore J. Phillips, M.D.
Role: PRINCIPAL_INVESTIGATOR
The MS Center at Texas Neurology
Joanna Cooper
Role: PRINCIPAL_INVESTIGATOR
Sutter East Bay Medical Foundation
James R. Storey
Role: PRINCIPAL_INVESTIGATOR
Upstate Clinical Research
Malcolm Gottesman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Winthrop University Hospital
Herman Sullivan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Michigan Medical P.C. Neurology
Timothy Vollmer, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Hospital and Medical Center, Phoenix
Jeffery Dunn, M.D.
Role: PRINCIPAL_INVESTIGATOR
MS Hub Medical Group
S. Mitchell Freedman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Raleigh Neurology Associates
Joseph Herbert, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital for Joint Diseases, MS Care Center
Omar Khan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wayne State University MS Center
Marcelo Kremenchutzky, M.D.
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Sharon Lynch, M.D.
Role: PRINCIPAL_INVESTIGATOR
CLMC Neurology
Alireza Minagar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center
Jeffrey English, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Multiple Sclerosis Center of Atlanta
Andrew Goodman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Michael Kaufman, M.D.
Role: PRINCIPAL_INVESTIGATOR
MS Center/CMC
Florian P. Thomas, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Louis University Hospital
Clyde Markowitz, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Jayne Martin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Michigan State University
Maria Melanson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Health Sciences Center
MaryAnn Picone, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gimble MS Center
Christopher Bever, M.D
Role: PRINCIPAL_INVESTIGATOR
Maryland Center for MS
Gregg G. Blevins, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Kasper Lloyd, M.D.
Role: PRINCIPAL_INVESTIGATOR
MS Center at Dartmouth
Yves Lapierrre, M.D.
Role: PRINCIPAL_INVESTIGATOR
Montreal Neurological Institute
John W. Rose, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah CAMT
Michael Yeung, M.D.
Role: PRINCIPAL_INVESTIGATOR
Foothills Medical Centre
Neil Lava, M.D.
Role: PRINCIPAL_INVESTIGATOR
Albany Medical College
Jonathan L. Carter, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Francois Jacques, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinique SEP/NM
William Honeycutt, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neurology Associates, P.A.
Istvan Pirko, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Ed Fox, M.D.
Role: PRINCIPAL_INVESTIGATOR
Central Texas Neurology
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation
Berkeley, California, United States
Neurology Associates, P.A.
Maitland, Florida, United States
The Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States
Consultants in Neurology
Northbrook, Illinois, United States
KUMC Neurology
Kansas City, Kansas, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Maryland Center for MS
Baltimore, Maryland, United States
Wayne State University MS Center
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Michigan Medical P.C. Neurology
Grand Rapids, Michigan, United States
St. Louis University Hospital
St Louis, Missouri, United States
MS Center at Dartmouth
Lebanon, New Hampshire, United States
Gimble MS Center
Teaneck, New Jersey, United States
Upstate Clinical Research
Albany, New York, United States
Albany Medical Center
Albany, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Hospital for Joint Diseases, MS Care Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
MS Center/CMC Meyers Park
Charlotte, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The MS Center at Texas Neurology
Dallas, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
University of Utah CAMT
Salt Lake City, Utah, United States
MS Hub Medical Group
Seattle, Washington, United States
Rockwood Clinic, PS
Spokane, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Foothills Medical Centre-MS Research Program
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Clinique SEP/NM
Gatineau, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Countries
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References
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Wynn D, Kaufman M, Montalban X, Vollmer T, Simon J, Elkins J, O'Neill G, Neyer L, Sheridan J, Wang C, Fong A, Rose JW; CHOICE investigators. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010 Apr;9(4):381-90. doi: 10.1016/S1474-4422(10)70033-8. Epub 2010 Feb 15.
Other Identifiers
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DAC-1012
Identifier Type: -
Identifier Source: org_study_id