Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
NCT ID: NCT01405820
Last Updated: 2015-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
290 participants
INTERVENTIONAL
2011-08-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
NCT00027300
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
NCT00559702
Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT01440101
Natalizumab Subcutaneous Immunogenicity and Safety Study
NCT02142192
Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
NCT01416155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Natalizumab 300 mg Intravenous (IV) Every 4 Weeks
Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks
Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
natalizumab SC
natalizumab for Subcutaneous Injection
Natalizumab 300 mg IV Every 12 Weeks
Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
IV Placebo
Intravenous placebo to natalizumab
Natalizumab 300 mg SC Every 12 Weeks
Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
natalizumab SC
natalizumab for Subcutaneous Injection
SC Placebo
Subcutaneous placebo to natalizumab
Natalizumab 150 mg IV Every 12 Weeks
Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
IV Placebo
Intravenous placebo to natalizumab
Natalizumab 150 mg SC Every 12 Weeks
Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
natalizumab IV
natalizumab for IV Infusion
natalizumab SC
natalizumab for Subcutaneous Injection
SC Placebo
Subcutaneous placebo to natalizumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
natalizumab IV
natalizumab for IV Infusion
natalizumab SC
natalizumab for Subcutaneous Injection
IV Placebo
Intravenous placebo to natalizumab
SC Placebo
Subcutaneous placebo to natalizumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects of childbearing potential must practice effective contraception during the study
* A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)
* Free of MS relapse for 12 months prior to randomization
* Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.
* In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse.
Exclusion Criteria
* Positive for anti-natalizumab antibodies at screening
* MRI positive for Gd-enhancing lesions at study entry
* Subjects for whom MRI is contraindicated
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease
* History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin)
* History of transplantation or any anti-rejection therapy
* History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug
* A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time
* Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Brasschaat, , Belgium
Research Site
Liège, , Belgium
Research Site
Overpelt, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Amiens, , France
Research Site
Besançon, , France
Research Site
Bron, , France
Research Site
Lille, , France
Research Site
Montpellier, , France
Research Site
Nantes, , France
Research Site
Nice, , France
Research Site
Paris, , France
Research Site
Rennes, , France
Research Site
Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Andernach, , Germany
Research Site
Bamberg, , Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Bonn, , Germany
Research Site
Dresden, , Germany
Research Site
Emmendingen, , Germany
Research Site
Erbach im Odenwald, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Heidelberg, , Germany
Research Site
Jena, , Germany
Research Site
Mainz, , Germany
Research Site
Marburg, , Germany
Research Site
München, , Germany
Research Site
Neuburg am Inn, , Germany
Research Site
Regensburg, , Germany
Research Site
Tübingen, , Germany
Research Site
Ulm, , Germany
Research Site
Wermsdorf, , Germany
Research Site
Bari, , Italy
Research Site
Catania, , Italy
Research Site
Cefalù, , Italy
Research Site
Chieti, , Italy
Research Site
Florence, , Italy
Research Site
Gallarate, , Italy
Research Site
L’Aquila, , Italy
Research Site
Milan, , Italy
Research Site
Montichiari, , Italy
Research Site
Napoli, , Italy
Research Site
Orbassano, , Italy
Research Site
Padua, , Italy
Research Site
Palermo, , Italy
Research Site
Pavia, , Italy
Research Site
Pozzilli, , Italy
Research Site
Roma, , Italy
Research Site
Sassari, , Italy
Research Site
Torino, , Italy
Research Site
Barcelona, , Spain
Research Site
Donostia / San Sebastian, , Spain
Research Site
Girona, , Spain
Research Site
Lleida, , Spain
Research Site
Málaga, , Spain
Research Site
Murcia, , Spain
Research Site
Oviedo, , Spain
Research Site
Pamplona, , Spain
Research Site
Santa Cruz de Tenerife, , Spain
Research Site
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-024000-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
101MS206
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.