En förlängningsstudie av Ublituximab hos deltagare med återfallande multipel skleros
En öppen förlängningsstudie av Ublituximab hos patienter med återfallande multipel skleros
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 [NCT03277261]) or TG1101-RMS302 (RMS302 [NCT03277248]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E [NCT03381170]) (United States of America [USA] participants only).
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
-
Grodno, Belarus, 230017
- TG Therapeutics Investigational Trial Site
-
Grodno, Belarus, 320017
- TG Therapeutics Investigational Trial Site
-
Minsk, Belarus, 220114
- TG Therapeutics Investigational Trial Site
-
Minsk, Belarus, 220116
- TG Therapeutics Investigational Trial Site
-
Minsk, Belarus, 220226
- TG Therapeutics Investigational Trial Site
-
-
-
-
California
-
Pasadena, California, Förenta staterna, 91105
- TG Therapeutics Investigational Trial Site
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80045
- TG Therapeutics Investigational Trial Site
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- TG Therapeutics Investigational Trial Site
-
Tampa, Florida, Förenta staterna, 33612
- TG Therapeutics Investigational Trial Site
-
-
Illinois
-
Northbrook, Illinois, Förenta staterna, 60062
- TG Therapeutics Investigational Trial Site
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160
- TG Therapeutics Investigational Trial Site
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48201
- TG Therapeutics Investigational Trial Site
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- TG Therapeutics Investigational Trial Site
-
-
New Jersey
-
Teaneck, New Jersey, Förenta staterna, 07666
- TG Therapeutics Investigational Trial Site
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87131
- TG Therapeutics Investigational Trial Site
-
-
New York
-
Amherst, New York, Förenta staterna, 14266
- TG Therapeutics Investigational Trial Site
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43214
- TG Therapeutics Investigational Trial Site
-
Westerville, Ohio, Förenta staterna, 43081
- TG Therapeutics Investigational Trial Site
-
-
Tennessee
-
Knoxville, Tennessee, Förenta staterna, 37922
- TG Therapeutics Investigational Trial Site
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75246
- TG Therapeutics Investigational Trial Site
-
Frisco, Texas, Förenta staterna, 75034
- TG Therapeutics Investigational Trial Site
-
Round Rock, Texas, Förenta staterna, 78681
- TG Therapeutics Investigational Trial Site
-
San Antonio, Texas, Förenta staterna, 78258
- TG Therapeutics Investigational Trial Site
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98109
- TG Therapeutics Investigational Trial Site
-
-
-
-
-
Tbilisi, Georgien, 00112
- TG Therapeutics Investigational Trial Site
-
Tbilisi, Georgien, 00114
- TG Therapeutics Investigational Trial Site
-
Tbilisi, Georgien, 00159
- TG Therapeutics Investigational Trial Site
-
Tbilisi, Georgien, 00160
- TG Therapeutics Investigational Trial Site
-
Tbilisi, Georgien, 00172
- TG Therapeutics Investigational Trial Site
-
Tbilisi, Georgien, 00179
- TG Therapeutics Investigational Trial Site
-
-
-
-
-
Osijek, Kroatien, 31000
- TG Therapeutics Investigational Trial Site
-
Varaždin, Kroatien, 42000
- TG Therapeutics Investigational Trial Site
-
Zagreb, Kroatien, 10000
- TG Investigational Trial Site
-
-
-
-
-
Katowice, Polen, 40-555
- TG Therapeutics Investigational Trial Site
-
Katowice, Polen, 40-568
- TG Therapeutics Investigational Trial Site
-
Katowice, Polen, 40-684
- TG Therapeutics Investigational Trial Site
-
Krakow, Polen, 31-505
- TG Therapeutics Investigational Trial Site
-
Lodz, Polen, 41-800
- TG Therapeutics Investigational Trial Site
-
Olsztyn, Polen, 10-561
- TG Therapeutics Investigational Trial Site
-
Poznan, Polen, 61-583
- TG Therapeutics Investigational Trial Site
-
Warsaw, Polen, 04-141
- TG Therapeutics Investigational Trial Site
-
Zabrze, Polen, 04-749
- TG Therapeutics Investigational Trial Site
-
-
-
-
-
Arkhangelsk, Ryssland, 163045
- TG Therapeutics Investigational Trial Site
-
Barnaul, Ryssland, 656045
- TG Therapeutics Investigational Trial Site
-
Bryansk, Ryssland, 241033
- TG Therapeutics Investigational Trial Site
-
Chelyabinsk, Ryssland, 454021
- TG Therapeutics Investigational Trial Site
-
Kemerovo, Ryssland, 650066
- TG Therapeutics Investigational Trial Site
-
Krasnoyarsk, Ryssland, 660037
- TG Therapeutics Investigational Trial Site
-
Kursk, Ryssland, 305007
- TG Therapeutics Investigational Trial Site
-
Moscow, Ryssland, 125367
- TG Therapeutics Investigational Trial Site
-
Moscow, Ryssland, 127015
- TG Therapeutics Investigational Trial Site
-
Nizhny Novgorod, Ryssland, 603155
- TG Therapeutics Investigational Trial Site
-
Novosibirsk, Ryssland, 630007
- TG Therapeutics Investigational Trial Site
-
Novosibirsk, Ryssland, 630087
- TG Therapeutics Investigational Trial Site
-
Pyatigorsk, Ryssland, 357538
- TG Therapeutics Investigational Trial Site
-
Saint Petersburg, Ryssland, 197002
- TG Therapeutics Investigational Trial Site
-
Saint Petersburg, Ryssland, 197110
- TG Therapeutics Investigational Trial Site
-
Saint Petersburg, Ryssland, 197376
- TG Therapeutics Investigational Trial Site
-
Saransk, Ryssland, 430032
- TG Therapeutics Investigational Trial Site
-
Smolensk, Ryssland, 214018
- TG Therapeutics Investigational Trial Site
-
Tomsk, Ryssland, 634050
- TG Therapeutics Investigational Trial Site
-
Tyumen, Ryssland, 625000
- TG Therapeutics Investigational Trial Site
-
Ufa, Ryssland, 450005
- TG Therapeutics Investigational Trial Site
-
Yekaterinburg, Ryssland, 620102
- TG Therapeutics Investigational Trial Site
-
-
-
-
-
Belgrade, Serbien, 11000
- TG Therapeutics Investigational Trial Site
-
Kragujevac, Serbien, 34000
- TG Therapeutics Investigational Trial Site
-
-
-
-
-
Cherkasy, Ukraina, 18009
- TG Therapeutics Investigational Trial Site
-
Chernihiv, Ukraina, 14001
- TG Therapeutics Investigational Trial Site
-
Chernihiv, Ukraina, 14029
- TG Therapeutics Investigational Trial Site
-
Chernivtsi, Ukraina, 58002
- TG Therapeutics Investigational Trial Site
-
Ivano-Frankivsk, Ukraina, 76008
- TG Therapeutics Investigational Trial Site
-
Kharkiv, Ukraina, 61058
- TG Therapeutics Investigational Trial Site
-
Kharkiv, Ukraina, 61103
- TG Therapeutics Investigational Trial Site
-
Kharkiv, Ukraina, 61176
- TG Therapeutics Investigational Trial Site
-
Kyiv, Ukraina, 03037
- TG Therapeutics Investigational Trial Site
-
Kyiv, Ukraina, 03115
- TG Therapeutics Investigational Trial Site
-
Lviv, Ukraina, 79000
- TG Therapeutics Investigational Trial Site
-
Lviv, Ukraina, 79010
- TG Therapeutics Investigational Trial Site
-
Odesa, Ukraina, 65009
- TG Therapeutics Investigational Trial Site
-
Poltava, Ukraina, 36011
- TG Therapeutics Investigational Trial Site
-
Ternopil, Ukraina, 46027
- TG Therapeutics Investigational Trial Site
-
Uzhhorod, Ukraina, 88018
- TG Therapeutics Investigational Trial Site
-
Vinnytsia, Ukraina, 21005
- TG Therapeutics Investigational Trial Site
-
Zaporizhia, Ukraina, 69065
- TG Therapeutics Investigational Trial Site
-
Zaporizhia, Ukraina, 96900
- TG Therapeutics Investigational Trial Site
-
Zhytomyr, Ukraina, 10002
- TG Therapeutics Investigational Trial Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Participants must meet the following criteria:
- Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
- Investigator believes may benefit from treatment with ublituximab
- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
Exclusion Criteria:
Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
-
Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- Absolute neutrophil count < 1.5 x 10e3/µL
- Hematocrit < 24%
- Platelet count < 150,000 cell/mm^3
- Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L
-
Active infection
-
Ongoing pregnancy (female participants)
-
Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
-
Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
-
Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
-
Participants with unstable disease activity
-
Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
-
Vaccination with live virus within 2 months of randomization
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ublituximab Infusions
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study. |
Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Annualized Relapse Rate (ARR)
Tidsram: Up to Week 336
|
ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years). |
Up to Week 336
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TG1101-RMS303
- 2019-003625-16 (EudraCT-nummer)
- 2019 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .