Cladribine Tablet ( DrugBank: Cladribine )
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 | 51 |
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 : 269 - 標的パスウェイ数 : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04695080 (ClinicalTrials.gov) | June 25, 2021 | 6/11/2020 | ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis | ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function? | Advanced Multiple Sclerosis;Progressive Multiple Sclerosis | Drug: Cladribine (MAVENCLAD®);Drug: Placebo | Queen Mary University of London | Barts & The London NHS Trust;University Hospital Plymouth NHS Trust;University of Edinburgh;The Leeds Teaching Hospitals NHS Trust;St George's University Hospitals NHS Foundation Trust;University Hospital Birmingham NHS Foundation Trust;Bedfordshire Hospitals NHS Foundation Trust;Northern Care Alliance NHS Foundation Trust;Walton Centre NHS Foundation Trust;Sheffield Teaching Hospitals NHS Foundation Trust;Belfast Health and Social Care Trust;NHS Lothian;NHS Lanarkshire;Barking, Havering and Redbridge University Hospitals NHS Trust;Royal Free London NHS Trust;Swansea Bay University Health Board;NHS Greater Glasgow and Clyde;Nottingham University Hospitals NHS Trust | Recruiting | 18 Years | N/A | All | 200 | Phase 2/Phase 3 | United Kingdom |
| 2 | EUCTR2020-003995-42-IT (EUCTR) | 13/05/2021 | 04/06/2021 | Extension 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 KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy | ||
| 3 | EUCTR2020-003874-30-DK (EUCTR) | 06/04/2021 | 23/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Hungary;Denmark | ||
| 4 | EUCTR2020-003874-30-CZ (EUCTR) | 03/02/2021 | 04/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Hungary;Czech Republic;Denmark;Italy | ||
| 5 | EUCTR2020-003995-42-CZ (EUCTR) | 03/02/2021 | 04/11/2020 | Extension 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Australia;Israel;Germany | ||
| 6 | EUCTR2020-003995-42-HU (EUCTR) | 18/01/2021 | 20/11/2020 | Extension 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 47 | Phase 4 | Czech Republic;Hungary;Canada;Finland;Australia;Israel;Germany | ||
| 7 | EUCTR2020-003874-30-HU (EUCTR) | 15/01/2021 | 20/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 4 | Hungary | ||
| 8 | EUCTR2020-003874-30-IT (EUCTR) | 08/01/2021 | 24/05/2021 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 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 KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 4 | France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy | ||
| 9 | EUCTR2020-003995-42-DE (EUCTR) | 18/12/2020 | 29/10/2020 | Extension 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany | ||
| 10 | EUCTR2020-003995-42-FI (EUCTR) | 15/12/2020 | 23/11/2020 | Extension 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 KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 4 | Canada;Finland;Australia;Israel;Germany | ||
| 11 | EUCTR2018-005038-39-GB (EUCTR) | 02/12/2020 | 29/09/2020 | A phase 2b study of Cladribine to halt deterioration in people with advanced multiple sclerosis | ChariotMS – A national (UK), multi-centre, randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial with cost-utility analysis of cladribine tablets (3.5mg/kg over two years) in people with advanced multiple sclerosis (EDSS 6.5-8.5). Is cladribine superior to placebo in protecting upper limb function? - ChariotMS - Cladribine for people with advanced multiple sclerosis | Advanced Multiple Sclerosis (EDSS 6.5-8.5) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;Level: LLT;Classification code 10078558;Term: Multiple sclerosis plaque;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10028246;Term: Multiple sclerosis aggravated;Classification code 10078559;Term: Multiple sclerosis brain lesion;System Organ Class: 10028245 - Multiple sclerosis MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10064137;Term: Progression of multiple sclerosis;Classification code 10053395;Term: Progressive multiple sclerosis;Classification code 10067063;Term: Progressive relapsing multiple sclerosis;Level: PTClassification co;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: MAVENCLAD INN or Proposed INN: Cladribine | Queen Mary University of London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United Kingdom | ||
| 12 | NCT04550455 (ClinicalTrials.gov) | September 16, 2020 | 2/9/2020 | A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets | A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets | Multiple Sclerosis | Drug: Cladribine Tablets | Keith Edwards, M.D. | EMD Serono | Recruiting | 21 Years | 65 Years | All | 30 | Phase 4 | United States |
| 13 | NCT05019248 (ClinicalTrials.gov) | September 1, 2020 | 19/8/2021 | Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine | A Non-interventional Observation Study to Evaluate Immune Responses Following Seasonal Influenza Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Cladribine Tablets | Multiple Sclerosis, Relapsing-Remitting;Vaccine Response Impaired | Biological: Most recent vaccine to seasonal influenza | Heinrich-Heine University, Duesseldorf | NULL | Recruiting | 18 Years | 60 Years | All | 260 | Germany | |
| 14 | NCT04178005 (ClinicalTrials.gov) | February 19, 2020 | 21/11/2019 | Cladribine Tablets After Treatment With Natalizumab (CLADRINA) | Cladribine Tablets After Treatment With Natalizumab (CLADRINA) | Multiple Sclerosis | Drug: Cladribine | University of Texas Southwestern Medical Center | EMD Serono | Recruiting | 18 Years | 60 Years | All | 40 | Phase 4 | United States |
| 15 | EUCTR2019-000069-19-HR (EUCTR) | 24/12/2019 | 20/02/2020 | Evaluating 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 | Evaluating 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 KGaA | NULL | Authorised-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): yes | Serbia;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 | ||
| 16 | EUCTR2019-000069-19-AT (EUCTR) | 20/11/2019 | 06/06/2019 | Evaluating 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 | Evaluating 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 17 | NCT03963375 (ClinicalTrials.gov) | October 28, 2019 | 23/5/2019 | Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis | Cladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple Sclerosis | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Cladribine | Washington University School of Medicine | EMD Serono | Recruiting | 18 Years | 65 Years | All | 50 | Phase 4 | United States |
| 18 | EUCTR2019-000069-19-PT (EUCTR) | 14/10/2019 | 13/05/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Serbia;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 | ||
| 19 | EUCTR2019-000069-19-IT (EUCTR) | 11/10/2019 | 01/09/2021 | Evaluating 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 | Evaluating 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 KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 20 | EUCTR2019-000069-19-PL (EUCTR) | 08/09/2019 | 27/06/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 21 | EUCTR2019-000069-19-BG (EUCTR) | 05/09/2019 | 04/06/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 22 | EUCTR2019-000069-19-LT (EUCTR) | 27/08/2019 | 10/06/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 23 | EUCTR2019-000069-19-ES (EUCTR) | 23/08/2019 | 04/07/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Authorised-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): yes | Serbia;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 | ||
| 24 | NCT03961204 (ClinicalTrials.gov) | August 15, 2019 | 22/5/2019 | Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS) | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: 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 (MS) | Drug: Cladribine | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Completed | 18 Years | 65 Years | All | 662 | Phase 4 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;Italy;Korea, Republic of;Lebanon;Lithuania;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Tunisia;Ukraine;United Kingdom |
| 25 | EUCTR2019-000069-19-SE (EUCTR) | 14/08/2019 | 10/05/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 26 | NCT03933202 (ClinicalTrials.gov) | July 22, 2019 | 29/4/2019 | A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) | Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) | Multiple Sclerosis | Drug: Cladribine Tablets | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | N/A | All | 325 | United States | |
| 27 | EUCTR2019-000069-19-CZ (EUCTR) | 12/07/2019 | 07/05/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United 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 | ||
| 28 | EUCTR2019-000069-19-EE (EUCTR) | 17/06/2019 | 22/05/2019 | Evaluating 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 | Evaluating 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 KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | 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;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;United States;Portugal | ||
| 29 | NCT03933215 (ClinicalTrials.gov) | May 21, 2019 | 29/4/2019 | A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS) | Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS) | Multiple Sclerosis | Drug: Cladribine Tablets | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | N/A | All | 100 | United States | |
| 30 | NCT03745144 (ClinicalTrials.gov) | January 17, 2019 | 14/11/2018 | Effects of Cladribine Tablets on the PK of Microgynon® | A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS | Relapsing Multiple Sclerosis (RMS) | Drug: Cladribine;Drug: Placebo;Drug: Microgynon® | Merck KGaA, Darmstadt, Germany | NULL | Active, not recruiting | 18 Years | 45 Years | Female | 24 | Phase 1 | Germany;Poland |
| 31 | NCT04086225 (ClinicalTrials.gov) | January 17, 2019 | 9/9/2019 | Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon® | A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the Pharmacokinetics of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With Relapsing Multiple Sclerosis (RMS). | Relapsing Multiple Sclerosis (RMS) | Drug: Cladribine;Drug: Placebo;Drug: Microgynon® | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Recruiting | 18 Years | 45 Years | Female | 34 | Phase 1 | Germany;Poland |
| 32 | EUCTR2009-017978-21-PL (EUCTR) | 17/08/2012 | 06/03/2012 | Prospective 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. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United 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 | ||
| 33 | EUCTR2009-017978-21-PT (EUCTR) | 06/07/2012 | 11/08/2011 | Prospective 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. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United 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 | ||
| 34 | EUCTR2009-017978-21-GR (EUCTR) | 17/01/2012 | 08/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective 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. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;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 | ||
| 35 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 36 | EUCTR2009-017978-21-LT (EUCTR) | 25/07/2011 | 30/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Serbia;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 | |||
| 37 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 38 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Not 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): no | United 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 | ||
| 39 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 40 | EUCTR2009-017978-21-FI (EUCTR) | 07/06/2011 | 28/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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 INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 41 | EUCTR2009-017978-21-CZ (EUCTR) | 06/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;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 | |||
| 42 | EUCTR2009-017978-21-GB (EUCTR) | 03/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United 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 | ||
| 43 | EUCTR2009-017978-21-IT (EUCTR) | 16/05/2011 | 05/01/2012 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE | 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 MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine Tablet INN or Proposed INN: CLADRIBINE Other descriptive name: 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 44 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 45 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 46 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 47 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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: 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 48 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | 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. - Geneva | NULL | Not 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): no | Serbia;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 | ||
| 49 | EUCTR2006-003366-33-IT (EUCTR) | 30/10/2008 | 08/01/2008 | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active disease | MULTIPLE SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: REBIF*SC 12SIR 12000000UI44MCG INN or Proposed INN: Cladribine | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Spain;Italy | ||
| 50 | EUCTR2006-003366-33-ES (EUCTR) | 13/02/2007 | 03/03/2010 | Estudio 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 | Estudio 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. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Italy | ||
| 51 | NCT00436826 (ClinicalTrials.gov) | November 30, 2006 | 15/2/2007 | A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) | A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active Disease | Multiple Sclerosis | Drug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta) | EMD Serono Research & Development Institute, Inc. | NULL | Completed | 18 Years | 65 Years | All | 172 | Phase 2 | United States;Italy;Russian Federation;Spain |