Ofatumumab Dose-finding in RRMS Patients - Full Text View

Sponsor:	Genmab
Collaborator:	GlaxoSmithKline
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00640328

Purpose

Ofatumumab is a fully human monoclonal antibody that targets a unique epitope on the CD20 molecule on the surface of B lymphocytes. Ofatumumab has been administered to several more than 500 patients in various indications.

The purpose of the trial is to investigate the safety (Part A) and the dose response of three doses of ofatumumab compared to placebo (Part B) in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The dose response as well as the effect of redosing of three doses of ofatumumab compared with placebo is explored on the brain disease activity as measured by MRI scans in adults with RRMS.

For clarification: In Part A the patients are treated in cohorts of increasing doses of ofatumumab, whereas in Part B patients will be randomised to one of three ofatumumab dose groups or placebo.

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: ofatumumab/placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-finding Trial of Ofatumumab in RRMS Patients

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Ofatumumab

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:

Safety and dose response of three doses of ofatumumab compared to placebo. The dose response will be determined on disease activity (lesions) as measured by MRI scans of the brain in subjects with RRMS. [ Time Frame: 6 months (efficacy/dose response - Part B, Safety - Part A) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluated the safety, pharmacokinetic profile and efficacy of ofatumumab compared to placebo in RRMS patients [ Time Frame: Safety (2 years), Efficacy (6 months/12 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	324
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part B - I: Experimental Parallel groups	Drug: ofatumumab/placebo 2 treatment courses (2x2 I.V. infusions) with a 6 month interval
Part B - II: Placebo Comparator Parallel groups	Drug: ofatumumab/placebo 2 treatment courses (2x2 I.V. infusions) with a 6 month interval

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments
Subject Diagnosed with Relapsing Remitting MS, as defined by McDonald Criteria
Age 18- 55 (both included)
Recent history of relapses in the subjects medical record
Expanded Disability Status Scale (EDSS) score at screening between 0 and 5.0
Female patients must be either post menopausal, surgically incapable for bearing children or willing to practicing an acceptable birthcontrol e.g. hormonal contraceptive, vaginal ring, intrauterine device during the study and for a period of 1 year following the last dose of trial drug. Female of reproductive potential must have a negative pregnancy test at screening prior to entry in the trial treatment period.

Exclusion Criteria:

Subjects diagnosed with secondary progressive, primary progressive or progressive relapsing MS or Neuromyelitis optica
Interferons or glatiramer acetate within the past 3 months
Patients who are unable to undergo MRI scan
Female subjects who are pregnant, breast feeding or planning to become pregnant during the trial
Additional protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640328

Locations

Czech Republic
MS Centre of Neurology Department, Hospital Teplice
Teplice, Czech Republic, 415 29
Czech Republic, Praha
MS centre of neurology clinic, Faculty policlinic
Praha 2, Praha, Czech Republic, 128 08
Denmark
Danish Multiple Sclerosis Research Centre, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Poland
Institute of Psychiatry and Neurology
Warszawa, Poland, 04-749
Department of Neurology, Medical University of Lodz
Lodz, Poland, 91-153
Serbia
Clinical Centre Nis, Clinic for Neurology
Nis, Serbia, 18000
Military Medical Academy, Clinic for Neurology
Belgrade, Serbia, 11 000
Clinical Centre of Serbia, Institute of Neurology
Belgrade, Serbia, 11 000
Sweden
Neuroimmunology Unit, Karolinska Hospital
Stockholm, Sweden, S-171 76
United Kingdom, Liverpool
The Waltn Centre for Neurology & Neurosurgery NHS Trust. Clinical Trials Unit
Fazakerley, Liverpool, United Kingdom, L97LJ

Sponsors and Collaborators

Genmab

GlaxoSmithKline

Investigators

Principal Investigator:

Per Soelberg Sørensen, Professor

Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark

More Information

No publications provided

Responsible Party:	Genmab A/S ( Cecilia Ericson, Lead Clinical Research Associate )
Study ID Numbers:	GEN414, GEN414
Study First Received:	March 18, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00640328 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committees; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium:Lead Ethics Committee and Local Ethics Committee; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Serbia: Ethics Committees; Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Czech Republic: Ethics Committees; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Poland: Ethics Committees

Keywords provided by Genmab:

RRMS
Ofatumumab
Genmab

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 08, 2010