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190 Diseases |  |
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- New trial, Real-world evidence, Real-world: Fingolimod Real World Experience: the French Grand-Est Cohort (clinicaltrials.gov) - Jun 15, 2016
P=N/A, N=1014, Completed, Sponsor: CHU de Reims
- | Ponvory (ponesimod) / Juvise Pharma, Vanda
Trial initiation date: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD (clinicaltrials.gov) - Jun 13, 2016
P2, N=30, Not yet recruiting, Sponsor: Actelion
Initiation date: Sep 2015 --> Jun 2016
- | Zeposia (ozanimod) / BMS
New P1 trial: Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS (clinicaltrials.gov) - Jun 13, 2016
P1, N=24, Not yet recruiting, Sponsor: Celgene
- cenerimod (ACT-334441) / Idorsia
Trial termination: Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 (clinicaltrials.gov) - Jun 11, 2016
P1, N=32, Terminated, Sponsor: Actelion
Suspended --> Terminated; Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported
- ||||||| Zeposia (ozanimod) / BMS
Trial completion, Phase classification, Enrollment change, Trial primary completion date: RADIANCE: Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients (clinicaltrials.gov) - Jun 10, 2016
P2/3, N=258, Completed, Sponsor: Celgene
No safety events leading to discontinuation were reported Active, not recruiting --> Completed | Phase classification: P2 --> P2/3 | N=210 --> 258 | Trial primary completion date: Apr 2016 --> Apr 2014
- ||| BMS-986166 / BMS
New P1 trial: A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects (clinicaltrials.gov) - Jun 4, 2016
P1, N=66, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- ||||| Enrollment closed, Enrollment change, Trial primary completion date: Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. (clinicaltrials.gov) - May 23, 2016
P3, N=106, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Phase classification: P2 --> P2/3 | N=210 --> 258 | Trial primary completion date: Apr 2016 --> Apr 2014 Recruiting --> Active, not recruiting | N=176 --> 106 | Trial primary completion date: Mar 2017 --> Jul 2016
- ||| New trial, Real-world evidence, Real-world: EFFECT: Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - May 18, 2016
P=N/A, N=3000, Not yet recruiting, Sponsor: Biogen
- | Tysabri (natalizumab) / Biogen
Clinical: NTZ2TTY: Methylprednisolone During the Switch Between Natalizumab and Fingolimod (clinicaltrials.gov) - May 12, 2016
P4, N=56, Recruiting, Sponsor: University Hospital, Clermont-Ferrand
- | fingolimod / Generic mfg.
Trial completion: Computerized Exercise Training for Cognitive Remediation in Adults With Multiple Sclerosis Treated With Gilenya (clinicaltrials.gov) - May 10, 2016
P=N/A, N=20, Completed, Sponsor: Stony Brook University
Recruiting --> Active, not recruiting | N=176 --> 106 | Trial primary completion date: Mar 2017 --> Jul 2016 Active, not recruiting --> Completed
- Tysabri (natalizumab) / Biogen, Royalty
Trial primary completion date: BEST-MS: Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis (clinicaltrials.gov) - May 9, 2016
P4, N=600, Recruiting, Sponsor: University Hospital, Toulouse
Active, not recruiting --> Completed Trial primary completion date: Feb 2016 --> Oct 2016
- Ponvory (ponesimod) / Juvise Pharma, Vanda
Trial primary completion date: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD (clinicaltrials.gov) - May 2, 2016
P2, N=30, Recruiting, Sponsor: Actelion
Trial primary completion date: Feb 2016 --> Oct 2016 Trial primary completion date: Nov 2016 --> Jun 2017
- |||| Ponvory (ponesimod) / Juvise Pharma, Vanda
Trial primary completion date, Head-to-Head: OPTIMUM: Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (clinicaltrials.gov) - May 2, 2016
P3, N=1100, Recruiting, Sponsor: Actelion
Trial primary completion date: Nov 2016 --> Jun 2017 Trial primary completion date: Apr 2018 --> Dec 2018
- || cenerimod (ACT-334441) / Idorsia
Phase classification, Trial primary completion date: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - May 2, 2016
P2, N=64, Recruiting, Sponsor: Actelion
Trial primary completion date: Apr 2018 --> Dec 2018 Phase classification: P1/2 --> P2 | Trial primary completion date: Jan 2017 --> May 2017
- glatiramer acetate / Generic mfg., fingolimod / Generic mfg.
Trial primary completion date, HEOR, Patient reported outcomes: Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate (clinicaltrials.gov) - Apr 25, 2016
P=N/A, N=120, Recruiting, Sponsor: University of Colorado, Denver
Phase classification: P1/2 --> P2 | Trial primary completion date: Jan 2017 --> May 2017 Trial primary completion date: Mar 2016 --> Mar 2017
- |||| fingolimod / Generic mfg.
Trial primary completion date: PARADIGMS: Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis (clinicaltrials.gov) - Apr 21, 2016
P3, N=190, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Mar 2016 --> Mar 2017 Trial primary completion date: Jul 2017 --> Aug 2022
- fingolimod / Generic mfg.
Biomarker, Enrollment closed, Trial primary completion date: MS-BMD: A Pilot Study Assessing the Impact of Gilenya Therapy on Bone Density Change in Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - Apr 18, 2016
P=N/A, N=36, Active, not recruiting, Sponsor: Simnad, Virginia, M.D.
Trial primary completion date: Jul 2017 --> Aug 2022 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Jul 2018
- mocravimod (KRP-203) / Priothera
Trial completion, Enrollment change: Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus (clinicaltrials.gov) - Apr 18, 2016
P2, N=10, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Jul 2018 Terminated --> Completed | N=22 --> 10
- |||| Enrollment open, Trial initiation date: Effect of Fingolimod on Neurodegeneration (clinicaltrials.gov) - Apr 14, 2016
P4, N=120, Recruiting, Sponsor: Novartis Pharmaceuticals
Terminated --> Completed | N=22 --> 10 Not yet recruiting --> Recruiting | Initiation date: Oct 2015 --> Feb 2016
- || amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Trial primary completion date: Extension Study of MT-1303 in Subjects With Crohn's Disease (clinicaltrials.gov) - Apr 11, 2016
P2, N=80, Recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
Not yet recruiting --> Recruiting | Initiation date: Oct 2015 --> Feb 2016 Trial primary completion date: May 2017 --> Aug 2017
- |||| amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Trial completion, Trial primary completion date: Extension Study of MT-1303 (clinicaltrials.gov) - Apr 11, 2016
P2, N=367, Completed, Sponsor: Mitsubishi Tanabe Pharma Corporation
Trial primary completion date: May 2017 --> Aug 2017 Active, not recruiting --> Completed | Trial primary completion date: Sep 2016 --> Mar 2016
- | Mayzent (siponimod) / Novartis
Trial completion: Safety and Efficacy of BAF312 in Dermatomyositis (clinicaltrials.gov) - Apr 7, 2016
P2, N=17, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Trial primary completion date: Sep 2016 --> Mar 2016 Terminated --> Completed
- || amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health
Trial primary completion date: Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease (clinicaltrials.gov) - Apr 4, 2016
P2, N=80, Recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
Terminated --> Completed Trial primary completion date: Aug 2016 --> Nov 2016
- ||||| fingolimod / Generic mfg.
Enrollment closed, Trial primary completion date: Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - Mar 30, 2016
P3, N=4123, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Aug 2016 --> Nov 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Oct 2018
- ||||| Biomarker, New P4 trial, IO biomarker: Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01) (clinicaltrials.gov) - Mar 25, 2016
P4, N=150, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- | Trial completion, Trial initiation date, HEOR: A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 (clinicaltrials.gov) - Mar 5, 2016
P4, N=42, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Oct 2018 Recruiting --> Completed | Initiation date: Jul 2012 --> Oct 2012
- | Mayzent (siponimod) / Novartis
Enrollment closed: Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (clinicaltrials.gov) - Feb 18, 2016
P3, N=40, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Completed | Initiation date: Jul 2012 --> Oct 2012 Recruiting --> Active, not recruiting
- ||||||| Trial completion: OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis (clinicaltrials.gov) - Feb 17, 2016
P3, N=579, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Completed
- Enrollment closed: Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - Feb 12, 2016
P=N/A, N=50, Active, not recruiting, Sponsor: University at Buffalo
Recruiting --> Completed Recruiting --> Active, not recruiting
- Trial primary completion date: Fingolimod in Schizophrenia Patients (clinicaltrials.gov) - Feb 8, 2016
P2, N=40, Recruiting, Sponsor: Indiana University
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2015 --> Dec 2016
- Mayzent (siponimod) / Novartis
Enrollment change, Trial termination, Trial primary completion date: Safety and Efficacy of BAF312 in Dermatomyositis (clinicaltrials.gov) - Jan 26, 2016
P2, N=16, Terminated, Sponsor: Novartis Pharmaceuticals
N=56 --> 16 | Recruiting --> Terminated | Trial primary completion date: Apr 2017 --> Feb 2016; The study was terminated prematurely after an interim analysis for futility. The study did not provide any evidence for efficacy of BAF312 in dermatomyositis.
- iSONEP (sonepcizumab) / Pfizer, Apollo Endosurgery
Trial termination, Trial primary completion date: A Phase 2 Study of ASONEP (clinicaltrials.gov) - Jan 20, 2016
P2, N=40, Terminated, Sponsor: Lpath, Inc.
The study did not provide any evidence for efficacy of BAF312 in dermatomyositis. Active, not recruiting --> Terminated | Trial primary completion date: Dec 2015 --> Sep 2015
- || fingolimod / Generic mfg.
Trial primary completion date: PASSOS: A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya (clinicaltrials.gov) - Jan 19, 2016
P4, N=100, Recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated | Trial primary completion date: Dec 2015 --> Sep 2015 Trial primary completion date: Dec 2017 --> Jun 2018
- |||| Trial completion, Enrollment change: ACROSS: Long-term Follow-up of Fingolimod Phase II Study Patients (clinicaltrials.gov) - Jan 19, 2016
P4, N=177, Completed, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Dec 2017 --> Jun 2018 Recruiting --> Completed | N=228 --> 177
- glatiramer acetate / Generic mfg., fingolimod / Generic mfg.
Trial primary completion date, HEOR, Patient reported outcomes: Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate (clinicaltrials.gov) - Jan 17, 2016
P=N/A, N=120, Recruiting, Sponsor: University of Colorado, Denver
Recruiting --> Completed | N=228 --> 177 Trial primary completion date: Dec 2015 --> Mar 2016
- ||||| Mayzent (siponimod) / Novartis
Enrollment closed, Trial primary completion date: Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) (clinicaltrials.gov) - Jan 15, 2016
P3, N=1651, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Dec 2015 --> Mar 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2016 --> Aug 2017
- Tysabri (natalizumab) / Biogen, Royalty
Enrollment change, Trial termination, Trial primary completion date: ESCALATE: Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies (clinicaltrials.gov) - Jan 11, 2016
P4, N=48, Terminated, Sponsor: Biogen
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2016 --> Aug 2017 N=130 --> 48 | Recruiting --> Terminated | Trial primary completion date: May 2017 --> Apr 2016; Business Decision
- | Tysabri (natalizumab) / Biogen, Royalty
Enrollment change, Trial termination, Trial primary completion date: REVEAL: Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants (clinicaltrials.gov) - Jan 11, 2016
P4, N=129, Terminated, Sponsor: Biogen
N=130 --> 48 | Recruiting --> Terminated | Trial primary completion date: May 2017 --> Apr 2016; Business Decision N=540 --> 129 | Recruiting --> Terminated | Trial primary completion date: May 2017 --> May 2016; Business Decision
- |||||| Zeposia (ozanimod) / BMS
Enrollment open: An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Jan 11, 2016
P3, N=1200, Recruiting, Sponsor: Receptos, Inc.
N=540 --> 129 | Recruiting --> Terminated | Trial primary completion date: May 2017 --> May 2016; Business Decision Not yet recruiting --> Recruiting
- mocravimod (KRP-203) / Priothera
Enrollment change, Trial primary completion date: A Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies (clinicaltrials.gov) - Jan 6, 2016
P1, N=30, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting N=10 --> 30 | Trial primary completion date: Mar 2017 --> May 2019
- Tysabri (natalizumab) / Biogen, Royalty
Trial primary completion date: BEST-MS: Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis (clinicaltrials.gov) - Dec 23, 2015
P4, N=600, Recruiting, Sponsor: University Hospital, Toulouse
N=10 --> 30 | Trial primary completion date: Mar 2017 --> May 2019 Trial primary completion date: Oct 2015 --> Feb 2016
- cenerimod (ACT-334441) / Idorsia
Trial primary completion date: Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 (clinicaltrials.gov) - Dec 23, 2015
P1, N=32, Suspended, Sponsor: Actelion
Trial primary completion date: Oct 2015 --> Feb 2016 Trial primary completion date: Sep 2015 --> Dec 2016
- New P1 trial: NMSNT: Use on Human Beings of Mix of Known Drugs for New Destination - MS Treatment (clinicaltrials.gov) - Dec 16, 2015
P1, N=90, Completed, Sponsor: Universit
- ||| Enrollment change: MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone (clinicaltrials.gov) - Dec 12, 2015
P4, N=1960, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Sep 2015 --> Dec 2016 N=2550 --> 1960
- |||| Velsipity (etrasimod) / Pfizer
Enrollment open: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - Dec 11, 2015
P2, N=180, Recruiting, Sponsor: Arena Pharmaceuticals
N=2550 --> 1960 Not yet recruiting --> Recruiting
- fingolimod / Generic mfg.
Enrollment closed, Trial primary completion date: Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya. (clinicaltrials.gov) - Dec 4, 2015
P=N/A, N=125, Active, not recruiting, Sponsor: University of Southern California
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2015 --> Sep 2016
- || icanbelimod (CBP-307) / Suzhou Connect Biopharma
Enrollment closed: Phase 1 Study Accessing the Safety and Tolerability of CBP-307 (clinicaltrials.gov) - Nov 21, 2015
P1, N=64, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2015 --> Sep 2016 Recruiting --> Active, not recruiting
- || Trial primary completion date, Patient reported outcomes: PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod (clinicaltrials.gov) - Oct 22, 2015
P=N/A, N=240, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2016 --> Dec 2016
- glatiramer acetate / Generic mfg., fingolimod / Generic mfg.
Trial primary completion date, HEOR, Patient reported outcomes: Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate (clinicaltrials.gov) - Oct 22, 2015
P=N/A, N=120, Recruiting, Sponsor: University of Colorado, Denver
Trial primary completion date: Jan 2016 --> Dec 2016 Trial primary completion date: Sep 2015 --> Dec 2015
- ||||| New P4 trial: Effect of Fingolimod on Neurodegeneration (clinicaltrials.gov) - Oct 22, 2015
P4, N=120, Not yet recruiting, Sponsor: Novartis Pharmaceuticals