| March 18, 2008 |
| June 3, 2009 |
| April 2008 |
| September 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00640328 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Ofatumumab Dose-Finding in RRMS Patients |
| A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Finding Trial of Ofatumumab in RRMS Patients |
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. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Relapsing Remitting Multiple Sclerosis |
| Drug: ofatumumab/placebo |
- Experimental: Parallel groups
- Placebo Comparator: Parallel groups
|
| |
| |
| Recruiting |
| 324 |
| September 2012 |
| September 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 55 Years |
| No |
|
|
| Belgium, Czech Republic, Denmark, Poland, Serbia, Sweden, United Kingdom |
| |
| NCT00640328 |
| Majken Westergaard, International Clinical Trial Manager, Genmab A/S |
| GEN414, GEN414 |
| Genmab |
| GlaxoSmithKline |
| Principal Investigator: |
Per Soelberg Sørensen, Professor |
Danish Multiple Sclerosis Research Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark |
|
|
| Genmab |
| June 2009 |
