Not applicable ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎114

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000028-36-BG
(EUCTR)
18/01/202208/11/2021Not applicableA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Product Name: Vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3United States;Belarus;Greece;Ukraine;Lithuania;North Macedonia;Russian Federation;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of
2EUCTR2020-004785-19-DE
(EUCTR)
07/07/202117/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;France;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany
3EUCTR2020-004785-19-CZ
(EUCTR)
01/06/202105/02/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany
4EUCTR2020-003995-42-IT
(EUCTR)
13/05/202104/06/2021Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy
5EUCTR2020-004785-19-BG
(EUCTR)
28/04/202109/03/2021Proof-of-concept study for SAR441344 in relapsing multiple sclerosisA Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: Not Applicable
Other descriptive name: SAR441344
Sanofi-Aventis Recherche et DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany
6EUCTR2020-003874-30-DK
(EUCTR)
06/04/202123/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality oflife in participants with highly-active relapsing multiple sclerosis, havingparticipated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Hungary;Denmark
7JPRN-jRCT2031200333
02/03/202129/01/2021A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) Neuromyelitis Optica Spectrum Disorder (NMOSD)Satralizumab: 120 mg SC injection every 4 weeks (Q4W)Hans-Christian von BuedingenNULLNot RecruitingNot applicableNot applicableBoth127Phase 4Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan
8EUCTR2020-003874-30-CZ
(EUCTR)
03/02/202104/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Hungary;Czech Republic;Denmark;Italy
9EUCTR2020-003995-42-CZ
(EUCTR)
03/02/202104/11/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Australia;Israel;Germany
10EUCTR2020-003995-42-HU
(EUCTR)
18/01/202120/11/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
47Phase 4Czech Republic;Hungary;Canada;Finland;Australia;Israel;Germany
11EUCTR2020-003874-30-HU
(EUCTR)
15/01/202120/11/2020Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 4Hungary
12EUCTR2020-003874-30-IT
(EUCTR)
08/01/202124/05/2021Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 4France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy
13EUCTR2020-003995-42-DE
(EUCTR)
18/12/202029/10/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany
14EUCTR2020-003995-42-FI
(EUCTR)
15/12/202023/11/2020Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck Healthcare KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 4Canada;Finland;Australia;Israel;Germany
15JPRN-jRCT2051210017
15/10/202007/05/2021An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of InebilizumabAn extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersThis study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects.Sato ToshiyukiNULLNot Recruiting>= 18age oldNot applicableBoth7Phase 3Japan
16EUCTR2017-003008-30-GB
(EUCTR)
01/07/202017/05/2018Simvastatin in Secondary Progressive Multiple SclerosisA double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 Multiple Sclerosis (Secondary Progressive)
MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Simvastatin 40 mg film-coated tablets
Product Name: Simvastatin 40 mg film-coated tablets
Product Code: Not applicable
INN or Proposed INN: Simvastatin
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United Kingdom
17EUCTR2019-000069-19-HR
(EUCTR)
24/12/201920/02/2020Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
18EUCTR2019-000069-19-AT
(EUCTR)
20/11/201906/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck, S.L.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
19EUCTR2019-000069-19-PT
(EUCTR)
14/10/201913/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Serbia;Estonia;United States;Portugal;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
20EUCTR2019-000069-19-IT
(EUCTR)
11/10/201901/09/2021Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribina
Product Code: [Not applicable]
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
21EUCTR2019-000069-19-PL
(EUCTR)
08/09/201927/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
22EUCTR2019-000069-19-BG
(EUCTR)
05/09/201904/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
23EUCTR2019-000069-19-LT
(EUCTR)
27/08/201910/06/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
24EUCTR2019-000069-19-ES
(EUCTR)
23/08/201904/07/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: CLADRIBINE
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSerbia;Portugal;United States;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
25EUCTR2019-000069-19-SE
(EUCTR)
14/08/201910/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
26EUCTR2019-000069-19-CZ
(EUCTR)
12/07/201907/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
27EUCTR2019-000069-19-EE
(EUCTR)
17/06/201922/05/2019Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribine tablets
Product Code: Not applicable
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;United States;Portugal
28EUCTR2015-000922-12-DE
(EUCTR)
12/02/201602/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
29EUCTR2015-000922-12-FR
(EUCTR)
28/01/201626/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
30EUCTR2015-000922-12-PL
(EUCTR)
05/01/201603/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
31EUCTR2015-000922-12-BE
(EUCTR)
04/01/201601/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
32EUCTR2015-000922-12-IE
(EUCTR)
22/12/201509/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
33EUCTR2015-000922-12-FI
(EUCTR)
15/12/201507/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
34EUCTR2015-000922-12-HR
(EUCTR)
11/12/201504/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
35EUCTR2015-000922-12-AT
(EUCTR)
19/11/201501/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
36JPRN-UMIN000018154
2015/07/0101/07/201511C-acetate PET for Multiple sclerosis11C-acetate PET for Multiple sclerosis - 11C-acetate PET for Multiple sclerosis Multiple Sclerosis, NMOWithdraw blood before and after the injection of 11C-acetatedepartment of neurology, Osaka university school of medicineNULLRecruiting20years-old75years-oldMale and Female30Not applicableJapan
37JPRN-UMIN000012705
2014/01/0707/01/2014The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis Relapsing-remitting multiple sclerosisTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.Department of Immunology, National Institute of Neuroscience, NCNPNULLRecruiting20years-old65years-oldMale and Female10Not applicableJapan
38JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET scan study with 11C-flumazenil
PET scan study with 18F- FDG
PET scan study with 15O-H2O
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
39EUCTR2009-017978-21-PL
(EUCTR)
17/08/201206/03/2012Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
40EUCTR2009-017978-21-PT
(EUCTR)
06/07/201211/08/2011Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
41JPRN-UMIN000009421
2012/06/2828/11/2012Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)administration of rituximabDepartment of Pediatrics, Kobe Universtiy Graduate School of MedicineNULLRecruitingNot applicable18years-oldMale and Female10Not applicableJapan
42JPRN-UMIN000007866
2012/05/0101/05/2012The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.Department of Immunology, National Institute of Neuroscience, NCNPDepartment of Neurology, Kinki University Faculty of MediceineComplete: follow-up continuing20years-old65years-oldMale and Female15Not applicableJapan
43EUCTR2009-017978-21-GR
(EUCTR)
17/01/201208/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
44EUCTR2010-021219-17-DE
(EUCTR)
31/10/201105/07/2011A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosisA 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable Primary progressive or relapse-free secondary progressive multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
INN or Proposed INN: masitinb mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
INN or Proposed INN: masitinb mesylate
AB ScienceNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina
45EUCTR2009-017978-21-DK
(EUCTR)
21/09/201112/09/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
46EUCTR2009-017978-21-LT
(EUCTR)
25/07/201130/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
47EUCTR2009-017978-21-ES
(EUCTR)
13/07/201117/11/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina.
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
48EUCTR2009-017978-21-BE
(EUCTR)
12/07/201129/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
49JPRN-UMIN000005889
2011/07/0108/07/2011The safety and efficacy of tocilizumab in patients with neuromyelitis optica neuromyelitis opticaTocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.Department of Immunology, National Institute of Neuroscience, NCNPNULLComplete: follow-up complete20years-old65years-oldMale and Female3Not applicableJapan
50EUCTR2009-017978-21-SE
(EUCTR)
08/06/201103/05/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
51EUCTR2009-017978-21-CZ
(EUCTR)
06/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
52EUCTR2009-017978-21-GB
(EUCTR)
03/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
53EUCTR2009-017978-21-LV
(EUCTR)
06/05/201118/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
54EUCTR2009-017978-21-AT
(EUCTR)
05/05/201131/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
55EUCTR2009-017978-21-EE
(EUCTR)
21/04/201113/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
56EUCTR2009-017978-21-BG
(EUCTR)
08/02/201111/09/2015Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
57EUCTR2009-017978-21-DE
(EUCTR)
20/12/201022/11/2010Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
58EUCTR2007-000381-20-BG
(EUCTR)
28/10/200820/10/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
59EUCTR2007-000381-20-GR
(EUCTR)
09/09/200801/04/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom
60EUCTR2007-000381-20-NL
(EUCTR)
29/08/200801/02/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
61EUCTR2007-000381-20-LT
(EUCTR)
15/07/200806/06/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
62JPRN-UMIN000002725
2008/07/0122/11/2009Efficacy of ramatroban in multiple sclerosis patients Multiple sclerosisAddition of ramatroban to conventional MS therapyIou hospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female5Not selectedJapan
63EUCTR2007-000381-20-LV
(EUCTR)
29/05/200812/05/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
64EUCTR2007-000381-20-EE
(EUCTR)
19/05/200828/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
65EUCTR2007-000381-20-PT
(EUCTR)
28/04/200815/01/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
66EUCTR2007-000381-20-CZ
(EUCTR)
23/04/200814/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
67EUCTR2007-000381-20-DK
(EUCTR)
15/04/200805/03/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
68EUCTR2007-000381-20-DE
(EUCTR)
17/03/200828/02/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
69EUCTR2007-000381-20-GB
(EUCTR)
04/03/200826/11/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
70EUCTR2007-000381-20-BE
(EUCTR)
21/01/200820/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
71EUCTR2006-001152-12-HU
(EUCTR)
09/01/200809/10/2007Not applicableAn international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
600United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany
72EUCTR2007-000381-20-AT
(EUCTR)
30/12/200703/01/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
73EUCTR2007-000381-20-FR
(EUCTR)
14/12/200717/10/2007A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MSA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany
74EUCTR2006-002982-38-LT
(EUCTR)
30/11/200701/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
75EUCTR2007-000381-20-FI
(EUCTR)
16/11/200715/10/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
76EUCTR2006-003037-32-LT
(EUCTR)
11/09/200727/11/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
77EUCTR2006-002982-38-PT
(EUCTR)
29/05/200722/02/2007A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
78EUCTR2006-002982-38-GR
(EUCTR)
08/05/200729/12/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
79EUCTR2006-003037-32-DE
(EUCTR)
13/04/200701/12/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
80EUCTR2006-002982-38-DE
(EUCTR)
16/03/200710/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
81EUCTR2006-002982-38-EE
(EUCTR)
15/03/200731/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
82EUCTR2006-003037-32-EE
(EUCTR)
06/03/200726/01/2007A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
83EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: not applicable
Product Name: Interferon beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy
84EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Estonia;Spain;Lithuania;Germany;Italy
85EUCTR2006-002982-38-SK
(EUCTR)
12/01/200706/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
86EUCTR2006-002982-38-FR
(EUCTR)
05/01/200724/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Serono International SANULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
87EUCTR2006-002982-38-DK
(EUCTR)
20/12/200630/11/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece
88EUCTR2006-002982-38-FI
(EUCTR)
19/12/200619/10/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
89EUCTR2006-002982-38-AT
(EUCTR)
04/12/200629/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Not Applicable
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
90EUCTR2006-002982-38-BE
(EUCTR)
29/11/200614/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany
91EUCTR2006-002982-38-CZ
(EUCTR)
03/11/200615/09/2006A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX)A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) Subjects at high risk of converting to Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta 1a FBS-free/HSA free, RNF
Product Code: Not Applicable
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
480Phase 3Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece
92EUCTR2006-001161-42-SE
(EUCTR)
17/10/200629/05/2006Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicableMulticentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable Multiple sclerosis (MS)Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
232Hungary;Germany;United Kingdom;Sweden
93EUCTR2004-002567-24-GB
(EUCTR)
09/10/200622/02/2005A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).
MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: MLN1202
Product Code: MLN1202
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Czech Republic;United Kingdom
94EUCTR2004-005148-28-LT
(EUCTR)
18/07/200602/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
95EUCTR2004-005148-28-LV
(EUCTR)
05/06/200611/01/2007A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
96EUCTR2004-005148-28-SK
(EUCTR)
01/06/200625/04/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
97EUCTR2004-005148-28-AT
(EUCTR)
22/11/200518/10/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Lithuania;Denmark;Austria;Latvia;Germany;Italy;United Kingdom
98EUCTR2004-005148-28-DE
(EUCTR)
17/11/200516/05/2006A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International, a branch of Laboratories Serono S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania
99EUCTR2005-001008-37-SE
(EUCTR)
01/11/200521/03/2005Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibodyAnalysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody Multiple sclerosisTrade Name: Rebif®
Product Name: Rebif®
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Sahlgrenska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Sweden
100EUCTR2004-005148-28-GB
(EUCTR)
28/10/200520/04/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International, a branch of Laboratoires Serono S.A.NULLNot Recruiting Female: yes
Male: yes
1290 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
101EUCTR2004-005148-28-EE
(EUCTR)
09/09/200531/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
102EUCTR2004-002567-24-HU
(EUCTR)
19/07/200506/04/2005A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicableA Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS).Product Name: MLN1202
Product Code: MLN1202
INN or Proposed INN: Not yet available
Other descriptive name: Not yet available
Millennium Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;United Kingdom;Czech Republic
103EUCTR2004-005148-28-CZ
(EUCTR)
14/07/200515/06/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;United Kingdom;Czech Republic;Denmark;Estonia;Italy;Latvia;Lithuania
104EUCTR2004-005148-28-BE
(EUCTR)
14/06/200505/07/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Czech Republic;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom
105EUCTR2004-005148-28-DK
(EUCTR)
02/06/200509/05/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
106EUCTR2004-005148-28-FI
(EUCTR)
26/05/200518/04/2005A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMSA phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Cladribine
Product Code: Not Applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1290Phase 3Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania
107EUCTR2004-003799-13-GB
(EUCTR)
16/03/200518/07/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
108EUCTR2004-003799-13-LT
(EUCTR)
08/03/200527/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3United Kingdom;Spain;Ireland;Sweden;Lithuania
109EUCTR2004-003799-13-DK
(EUCTR)
24/02/200518/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
110EUCTR2004-004130-14-AT
(EUCTR)
17/02/200513/01/2005A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).Product Name: Natalizumab
Product Code: Not Applicable
INN or Proposed INN: natalizumab
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Biogen Idec GmbHNULLNot RecruitingFemale: yes
Male: yes
1050Austria
111EUCTR2004-003799-13-ES
(EUCTR)
17/02/200504/11/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
112EUCTR2004-003799-13-SE
(EUCTR)
03/02/200523/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3United Kingdom;Spain;Ireland;Lithuania;Sweden
113EUCTR2004-000337-12-HU
(EUCTR)
23/07/200429/09/2004A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyA multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study MS with 2 or more relapses within the last 2 years
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Trade Name: Rebif
Product Name: Rebif
Product Code: Not applicable
INN or Proposed INN: Interferon beta-1a
Other descriptive name: Recombinant human interferon beta
Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 4Hungary
114EUCTR2004-003799-13-IE
(EUCTR)
13/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden