Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis

NCT00109161 | Completed Phase 2

• 1 other identifier: DAC-1012
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 36

Brief Summary

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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, CNS, Daclizumab

Outcome Measures

Primary Outcomes (1)

• Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients

Secondary Outcomes (3)

• Pharmacokinetics

• Immunogenicity

• Clinical improvement

Interventions

Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female age 18 to 55 years, inclusive.
• 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.

You may not qualify if:

• Pregnant or breast-feeding woman.
• 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.

Sponsors & Collaborators

• PDL BioPharma, Inc.: lead

Study Sites (36)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85013, United States

Location

Sutter East Bay Medical Foundation

Berkeley, California, 94705, United States

Location

Neurology Associates, P.A.

Maitland, Florida, 32751, United States

Location

The Multiple Sclerosis Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

Consultants in Neurology

Northbrook, Illinois, 60062, United States

Location

KUMC Neurology

Kansas City, Kansas, 66160, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Maryland Center for MS

Baltimore, Maryland, 21201, United States

Location

Wayne State University MS Center

Detroit, Michigan, 48201, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Michigan Medical P.C. Neurology

Grand Rapids, Michigan, 49525, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

MS Center at Dartmouth

Lebanon, New Hampshire, 03756, United States

Location

Gimble MS Center

Teaneck, New Jersey, 07666, United States

Location

Upstate Clinical Research

Albany, New York, 12205, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Hospital for Joint Diseases, MS Care Center

New York, New York, 10003, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MS Center/CMC Meyers Park

Charlotte, North Carolina, 28207, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The MS Center at Texas Neurology

Dallas, Texas, 75214, United States

Location

Central Texas Neurology

Round Rock, Texas, 78681, United States

Location

University of Utah CAMT

Salt Lake City, Utah, 84108, United States

Location

MS Hub Medical Group

Seattle, Washington, 98101, United States

Location

Rockwood Clinic, PS

Spokane, Washington, 99202, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801, United States

Location

Foothills Medical Centre-MS Research Program

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G-2C8, Canada

Location

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Clinique SEP/NM

Gatineau, Quebec, PQ J8Y 1W7, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Related Publications (1)

• 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.

  PMID: 20163990 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Daclizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2005
• First Posted: April 25, 2005
• Study Start: April 1, 2005
• Study Completion: October 1, 2006
• Last Updated: August 5, 2008

Record last verified: 2008-08

Locations

US (30); CA (6)