Clinical trials: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin [KLH]) and a recall antigen (tetanus toxoid [Td])…
- Trial name
- NCT00536120
- Testing
- BG00002 (natalizumab), keyhole limpet hemocyanin (KLH), tetanus diphtheria toxoid vaccine (Td)
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing Forms
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
- Trial name
- NCT01585766
- Testing
- MEDI-551 30 MG-IV, MEDI-551 60 MG-SC, MEDI-551 100 MG-IV
- Where
- 16 sites in United States, Poland and 2 more
- Volunteers
- 56 people
- Sponsor
- MedImmune LLC
Multiple Sclerosis
Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
- Trial name
- RNF (NCT00110396)
- Testing
- Interferon-beta-1a FBS-free/HSA-free
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- EMD Serono
Multiple Sclerosis
Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate
The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated…
- Trial name
- GATEWAYII (NCT01569451)
- Testing
- Rituximab, Glatiramer Acetate
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Colorado, Denver
Relapsing Multiple Sclerosis (RMS)
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV…
- Trial name
- ULTIMATE II (NCT03277248)
- Testing
- Ublituximab, Teriflunomide
- Where
- 13 sites in United States
- Volunteers
- 545 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
- Trial name
- NCT01199861
- Testing
- Fingolimod, Seasonal influenza vaccine, Tetanus toxoid vaccine
- Where
- 25 sites in Belgium, Canada and 7 more
- Volunteers
- 138 people
- Sponsor
- Novartis
Relapsing Forms of Multiple Sclerosis
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program.
- Trial name
- NCT01201356
- Testing
- Fingolimod
- Where
- 458 sites in United States, Argentina and 36 more
- Volunteers
- 4,125 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing Multiple Sclerosis (RMS)
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV…
- Trial name
- ULTIMATE 1 (NCT03277261)
- Testing
- Ublituximab, Teriflunomide
- Where
- 14 sites in United States
- Volunteers
- 549 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary…
- Trial name
- GEMINI 2 (NCT04410991)
- Testing
- Tolebrutinib, Teriflunomide HMR1726
- Where
- 186 sites in United States, Argentina and 26 more
- Volunteers
- 899 people
- Sponsor
- Sanofi
Multiple Sclerosis
A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)
The goal of this study was to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the treatment of multiple sclerosis (MS).
- Trial name
- ONWARD (NCT00436826)
- Testing
- Cladribine, Interferon-beta (IFN-beta)
- Where
- 39 sites in United States, Italy and 2 more
- Volunteers
- 172 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
ACTH in Progressive Forms of MS
This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting…
- Conditions
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Trial name
- NCT01950234
- Testing
- ACTH
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of Minnesota
Multiple Sclerosis
Natalizumab High Titer Immunogenicity and Safety
The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with…
- Trial name
- NCT00516893
- Testing
- BG00002-E (natalizumab high titer)
- Where
- 13 sites in United States
- Volunteers
- 113 people
- Sponsor
- Biogen
Multiple Sclerosis
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Primary Objective: To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS) participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA treatment, for future Deoxyribonucleic…
- Trial name
- LEMTRADA-ITP (NCT03784898)
- Testing
- Blood draw for future biomarker analysis
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Genzyme, a Sanofi Company
Multiple Sclerosis, Relapsing-Remitting
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot…
- Trial name
- NCT04121221
- Testing
- GA Depot
- Where
- 112 sites in United States, Belarus and 8 more
- Volunteers
- 1,016 people
- Sponsor
- Mapi Pharma Ltd.
Multiple Sclerosis
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl…
- Trial name
- MITIGATE (NCT02410278)
- Testing
- dimethyl fumarate, montelukast
- Where
- 50 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no…
- Trial name
- NCT05028634
- Testing
- Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine, Seasonal influenza vaccine
- Where
- 33 sites in United States, Germany
- Volunteers
- 63 people
- Sponsor
- Celgene
Relapsing Multiple Sclerosis
Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies
The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex…
- Trial name
- ESCALATE (NCT02241785)
- Testing
- natalizumab
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- Biogen
Relapsing Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary…
- Trial name
- GEMINI 1 (NCT04410978)
- Testing
- Tolebrutinib, Teriflunomide
- Where
- 179 sites in United States, Austria and 22 more
- Volunteers
- 974 people
- Sponsor
- Sanofi
Relapsing Forms of Multiple Sclerosis
A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)
The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF…
- Trial name
- NCT05083923
- Testing
- Diroximel fumarate
- Where
- 52 sites in China, Japan
- Volunteers
- 136 people
- Sponsor
- Biogen
Multiple Sclerosis
Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI
This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.
- Trial name
- BECOME (NCT00176592)
- Testing
- Betaseron, Copaxone
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of Medicine and Dentistry of New Jersey