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Sponsors and Collaborators: |
Genmab GlaxoSmithKline |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00640328 |
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 |
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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 |
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 |
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Part B - I: Experimental
Parallel groups
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Drug: ofatumumab/placebo
2 treatment courses (2x2 I.V. infusions) with a 6 month interval
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Part B - II: Placebo Comparator
Parallel groups
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Drug: ofatumumab/placebo
2 treatment courses (2x2 I.V. infusions) with a 6 month interval
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Majken Westergaard, PhD | +4570202728 | m.westergaard@genmab.com |
Belgium | |
Algemeen Ziekenhuis Sint-Jan Neurologie | Withdrawn |
Brugge, Belgium, 8000 | |
Czech Republic | |
MS Centre of Neurology Department, Hospital Teplice | Recruiting |
Teplice, Czech Republic, 415 29 | |
Contact: Johan Kristianson, Lead CRA + 45 7020 2728 | |
Czech Republic, Praha | |
MS centre of neurology clinic, Faculty policlinic | Recruiting |
Praha 2, Praha, Czech Republic, 128 08 | |
Contact: Johan Kristianson, Lead CRA + 45 70202728 | |
Denmark | |
Danish Multiple Sclerosis Research Centre, Copenhagen University Hospital | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Johan Kristianson, Lead CRA +45 7020 2728 | |
Poland | |
Institute of Psychiatry and Neurology | Recruiting |
Warszawa, Poland, 04-749 | |
Contact: Johan Kristianson, Lead CRA + 45 70202728 | |
Department of Neurology, Medical University of Lodz | Recruiting |
Lodz, Poland, 91-153 | |
Contact: Johan Kristianson, Lead CRA + 45 70202728 | |
Serbia | |
Clinical Centre Nis, Clinic for Neurology | Recruiting |
Nis, Serbia, 18000 | |
Contact: Johan Kristianson, Lead CRA + 45 7020 2728 | |
Military Medical Academy, Clinic for Neurology | Recruiting |
Belgrade, Serbia, 11 000 | |
Contact: Johan Kristianson, Lead CRA + 45 7020 2728 | |
Clinical Centre of Serbia, Institute of Neurology | Recruiting |
Belgrade, Serbia, 11 000 | |
Contact: Johan Kristianson, Lead CRA + 45 7020 2728 | |
Sweden | |
Neuroimmunology Unit, Karolinska Hospital | Recruiting |
Stockholm, Sweden, S-171 76 | |
Contact: Johan Kristianson, Lead CRA +45 70202728 | |
United Kingdom | |
Royal Hallamshire Hospital, Department of Neurology | Recruiting |
Sheffield, United Kingdom, S10 2JF | |
Contact: Ellen Spellman, PhD, Project Manager + 44 (0)1438 342428 | |
United Kingdom, Liverpool | |
The Waltn Centre for Neurology & Neurosurgery NHS Trust. Clinical Trials Unit | Recruiting |
Fazakerley, Liverpool, United Kingdom, L97LJ | |
Contact: Ellen Spellman, PhD, Project Manager + 44 (0) 1438342428 |
Principal Investigator: | Per Soelberg Sørensen, Professor | Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark |
Responsible Party: | Genmab A/S ( Majken Westergaard, International Clinical Trial Manager ) |
Study ID Numbers: | GEN414, GEN414 |
Study First Received: | March 18, 2008 |
Last Updated: | June 3, 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 |
RRMS Ofatumumab Genmab |
Signs and Symptoms Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
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 |