Multiple Sclerosis Clinical Trial

A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

Summary

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

View Full Description

Full Description

The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.

View Eligibility Criteria

Eligibility Criteria

Eligibility Criteria:

To be eligible to participate in this trial, patients must meet all of the following criteria:

Completed one of the parent trials
Does not have a condition that would require withdrawal from one of the parent trials
Has no conditions requiring treatment with a prohibited concomitant medication

Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:

At Baseline (Day 1)

CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
Female patients of childbearing potential:

Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.

Acceptable methods of birth control in this study are the following:

Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
Placement of an intrauterine device (IUD)
Placement of an intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner
Sexual abstinence.

Exclusion Criteria:

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

2494

Study ID:

NCT02576717

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 162 Locations for this study

See Locations Near You

Local Institution - 115
Phoenix Arizona, 85004, United States
Local Institution - 118
Phoenix Arizona, 85013, United States
Local Institution - 110
Berkeley California, 94705, United States
Local Institution - 103
Fresno California, 93710, United States
Local Institution - 122
Long Beach California, 90806, United States
Local Institution - 112
Sacramento California, 95817, United States
Local Institution - 120
San Francisco California, 94158, United States
Local Institution - 114
Maitland Florida, 32751, United States
Local Institution - 123
Port Charlotte Florida, 33952, United States
Local Institution - 124
Sunrise Florida, 33351, United States
Local Institution - 147
Tampa Florida, 33609, United States
Local Institution - 137
Golden Valley Minnesota, 55422, United States
Local Institution - 170
Las Vegas Nevada, 89106, United States
Local Institution - 143
Raleigh North Carolina, 27607, United States
Local Institution - 107
Westerville Ohio, 43801, United States
Local Institution - 144
Knoxville Tennessee, 37922, United States
Local Institution - 138
Lubbock Texas, 79410, United States
Local Institution - 179
Round Rock Texas, 78681, United States
Local Institution - 141
Kirkland Washington, 98034, United States
Local Institution - 904
Gomel , 24602, Belarus
Local Institution - 907
Grodno , 23001, Belarus
Local Institution - 902
Minsk , 22002, Belarus
Local Institution - 901
Minsk , 22011, Belarus
Local Institution - 903
Minsk , 22011, Belarus
Local Institution - 905
Vitebsk , 21002, Belarus
Local Institution - 906
Vitebsk , 21003, Belarus
Local Institution - 256
Brugge , 8000, Belgium
Local Institution - 255
Bruxelles , 1200, Belgium
Local Institution - 252
Montegnee , 4420, Belgium
Local Institution - 913
Banja Luka , 51000, Bosnia and Herzegovina
Local Institution - 911
Sarajevo , 71000, Bosnia and Herzegovina
Local Institution - 453
Sofia , 1113, Bulgaria
Local Institution - 454
Sofia , 1113, Bulgaria
Local Institution - 452
Sofia , 1309, Bulgaria
Local Institution - 456
Sofia , 1407, Bulgaria
Local Institution - 457
Sofia , 1431, Bulgaria
Local Institution - 460
Sofia , 1431, Bulgaria
Local Institution - 455
Sofia , 1606, Bulgaria
Local Institution - 923
Osijek , 31000, Croatia
Local Institution - 921
Zagreb , 10000, Croatia
Local Institution - 922
Zagreb , 10000, Croatia
Local Institution - 924
Zagreb , 10000, Croatia
Local Institution - 473
Tallinn , 10138, Estonia
Local Institution - 471
Tallinn , 10617, Estonia
Local Institution - 472
Tartu , EE-51, Estonia
Local Institution - 301
Tbilisi , 0112, Georgia
Local Institution - 302
Tbilisi , 0160, Georgia
Local Institution - 304
Tbilisi , 0160, Georgia
Local Institution - 306
Tbilisi , 0177, Georgia
Local Institution - 303
Tbilisi , 0179, Georgia
Local Institution - 487
Leipzig , 04103, Germany
Local Institution - 496
Potsdam , 14471, Germany
Local Institution - 488
Ulm , 89079, Germany
Local Institution - 552
Athens , 10676, Greece
Local Institution - 553
Athens , 115 2, Greece
Local Institution - 551
Athens , 11525, Greece
Local Institution - 555
Thessaloniki , 57010, Greece
Local Institution - 352
Budapest , 1145, Hungary
Local Institution - 356
Budapest , 1204, Hungary
Local Institution - 354
Esztergom , 2500, Hungary
Local Institution - 358
Kistarcsa , 2143, Hungary
Local Institution - 351
Nyiregyhaza , 4400, Hungary
Local Institution - 654
Catania , 95123, Italy
Local Institution - 653
Cefalu , 90015, Italy
Local Institution - 655
Milan , 20122, Italy
Local Institution - 659
Montichiari , 25018, Italy
Local Institution - 651
Roma , 00133, Italy
Local Institution - 562
Riga , LV-10, Latvia
Local Institution - 561
Riga , LV100, Latvia
Local Institution - 622
Kaunas Kauno Apskritis, LT-50, Lithuania
Local Institution - 621
Klaipeda , LT-92, Lithuania
Local Institution - 932
Chisinau , 2004, Moldova, Republic of
Local Institution - 931
Chisinau , 2028, Moldova, Republic of
Local Institution - 933
Chisinau , 2028, Moldova, Republic of
Local Institution - 511
Christchurch , 8011, New Zealand
Local Institution - 510
Hamilton , 2001, New Zealand
Local Institution - 434
Warszawa Mazowieckie, 05-07, Poland
Local Institution - 401
Bialystok , 15-42, Poland
Local Institution - 423
Bydgoszcz , 85-79, Poland
Local Institution - 406
Czeladz , 41-25, Poland
Local Institution - 405
Gdansk , 80-80, Poland
Local Institution - 432
Jaroslaw , 37-50, Poland
Local Institution - 417
Katowice , 40-55, Poland
Local Institution - 427
Katowice , 40-59, Poland
Local Institution - 426
Katowice , 40-65, Poland
Local Institution - 407
Katowice , 40-74, Poland
Local Institution - 424
Kielce , 25-72, Poland
Local Institution - 404
Konstancin Jeziorna , 05-51, Poland
Local Institution - 414
Krakow , 31-30, Poland
Local Institution - 429
Lublin , 20-05, Poland
Local Institution - 412
Lublin , 20-71, Poland
Local Institution - 420
Lublin , 20-71, Poland
Local Institution - 411
Lódzkie , 90-32, Poland
Local Institution - 431
Mazowieckie , 02-09, Poland
Local Institution - 415
Olsztyn , 10-56, Poland
Local Institution - 421
Plewiska , 62-06, Poland
Local Institution - 425
Pomorskie , 80-29, Poland
Local Institution - 408
Poznan , 60-35, Poland
Local Institution - 418
Poznan , 61-85, Poland
Local Institution - 433
Rybnik , 44-20, Poland
Local Institution - 435
Rzeszow , 35-32, Poland
Local Institution - 419
Szczecin , 70-11, Poland
Local Institution - 402
Warminsko-mazurskie , 10-44, Poland
Local Institution - 410
Warsaw , 00-73, Poland
Local Institution - 428
Warszawa , 01-69, Poland
Local Institution - 422
Warszawa , 02-50, Poland
Local Institution - 403
Warszawa , 02-95, Poland
Local Institution - 413
Warszawa , 04-14, Poland
Local Institution - 772
Braga , 4710-, Portugal
Local Institution - 775
Coimbra , 3000-, Portugal
Local Institution - 773
Torres Vedras , 2560-, Portugal
Local Institution - 503
Brasov , 50012, Romania
Local Institution - 509
Bucharest , 02232, Romania
Local Institution - 504
Bucharest , 20125, Romania
Local Institution - 520
Bucharest , 20125, Romania
Local Institution - 502
Campulung , 11510, Romania
Local Institution - 508
Cluj Napoca , 40001, Romania
Local Institution - 501
Cluj-Napoca , 40034, Romania
Local Institution - 507
Constanta , 90012, Romania
Local Institution - 506
Timisoara , 30073, Romania
Local Institution - 602
Belgrade , 11000, Serbia
Local Institution - 603
Belgrade , 11000, Serbia
Local Institution - 604
Belgrade , 11000, Serbia
Local Institution - 601
Belgrade , 11080, Serbia
Local Institution - 605
Kragujevac , 34000, Serbia
Local Institution - 606
Nis , 18000, Serbia
Local Institution - 946
Bratislava , 833 0, Slovakia
Local Institution - 942
Lucenec , 984 0, Slovakia
Local Institution - 945
Trnava , 91775, Slovakia
Local Institution - 953
Pretoria , 0040, South Africa
Local Institution - 756
Barcelona , 08003, Spain
Local Institution - 758
Barcelona , 08035, Spain
Local Institution - 761
Bilbao , 48013, Spain
Local Institution - 760
Girona , 17190, Spain
Local Institution - 757
Madrid , 28006, Spain
Local Institution - 754
Majadahonda , 28222, Spain
Local Institution - 764
Pamplona/ Navarra , 31008, Spain
Local Institution - 759
San Sebastian , 20014, Spain
Local Institution - 766
Sant Joan Despí , 08970, Spain
Local Institution - 755
Sevillla , 41009, Spain
Local Institution - 767
Valencia , 46010, Spain
Local Institution - 752
Valencia , 46026, Spain
Local Institution - 780
Goteborg , SE-41, Sweden
Local Institution - 823
Cherkasy , 18009, Ukraine
Local Institution - 830
Chernihiv , 14001, Ukraine
Local Institution - 805
Chernihiv , 14029, Ukraine
Local Institution - 813
Chernivtsi , 58018, Ukraine
Local Institution - 802
Dnipropetrovsk , 49027, Ukraine
Local Institution - 815
Dnipropetrovsk , 49027, Ukraine
Local Institution - 801
Ivano Frankivsk , 76008, Ukraine
Local Institution - 829
Ivano-Frankivsk , 76018, Ukraine
Local Institution - 814
Kharkiv , 61018, Ukraine
Local Institution - 827
Kharkiv , 61022, Ukraine
Local Institution - 832
Kharkiv , 61176, Ukraine
Local Institution - 811
Kherson , 73000, Ukraine
Local Institution - 822
Kyiv , 03115, Ukraine
Local Institution - 803
Kyiv , 04107, Ukraine
Local Institution - 818
Kyiv , 3110, Ukraine
Local Institution - 824
Kyiv , 3110, Ukraine
Local Institution - 817
Lutsk , 43024, Ukraine
Local Institution - 812
Lviv , 79010, Ukraine
Local Institution - 821
Lviv , 79044, Ukraine
Local Institution - 810
Odesa , 65009, Ukraine
Local Institution - 831
Odesa , 65025, Ukraine
Local Institution - 804
Odesa , 65117, Ukraine
Local Institution - 826
Poltava , 36011, Ukraine
Local Institution - 820
Uzhhorod , 88018, Ukraine
Local Institution - 809
Vinnytsia , 21005, Ukraine
Local Institution - 825
Zaporizhia , 69065, Ukraine
Local Institution - 828
Zaporizhzhia , 69600, Ukraine
Local Institution - 806
Zaporizhzhya , 69035, Ukraine
Local Institution - 819
Zhytomyr , 10008, Ukraine
Local Institution - 965
East Sussex , BN2 5, United Kingdom
Local Institution - 963
Inverness , IV2 3, United Kingdom
Local Institution - 964
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

2494

Study ID:

NCT02576717

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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