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Clinical trials for Methotrexate

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    1,059 result(s) found for: Methotrexate. Displaying page 8 of 53.
    EudraCT Number: 2004-000242-20 Sponsor Protocol Number: EURAMOS 1 Start Date*: 2005-04-05
    Sponsor Name:SSG
    Full Title: A randomised trial of the European and American Osteosarcoma Study group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy
    Medical condition: Ostesarcoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) NO (Completed) BE (Completed) IE (Completed) AT (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002324-32 Sponsor Protocol Number: I4V-MC-JADZ Start Date*: 2013-02-25
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who H...
    Medical condition: Moderately to severely active rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) DE (Completed) GB (Completed) PT (Completed) AT (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003031-19 Sponsor Protocol Number: IELSG42 Start Date*: 2014-12-15
    Sponsor Name:IELSG (INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP)
    Full Title: An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination, followed by high-dose chemotherapy supported by auto...
    Medical condition: systemic diffuse large B-cell lymphoma with central nervous system involvement at diagnosis or relapse
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003296-36 Sponsor Protocol Number: C0524T06 Start Date*: 2006-03-29
    Sponsor Name:Centocor B.V.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthr...
    Medical condition: Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-003430-13 Sponsor Protocol Number: AALL0932 Start Date*: 2014-01-14
    Sponsor Name:Children's Oncology Group
    Full Title: Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)
    Medical condition: Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10003939 B-lymphoblastic lymphoma (Kiel Classification) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005692-18 Sponsor Protocol Number: 1263-300 Start Date*: 2007-07-24
    Sponsor Name:ViroPharma Incorporated
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ALLOGENEIC STE...
    Medical condition: Main purpose is to assess the efficacy and safety of prophylactic use of Maribavir to prevent cytomegalovirus disease in recipients of allogeneic stem cell transplants.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009701 CMV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) FR (Completed) GB (Prematurely Ended) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004348-39 Sponsor Protocol Number: 1708155 Start Date*: 2018-02-15
    Sponsor Name:CHU Saint-Etienne
    Full Title: Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate
    Medical condition: rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10042952 Systemic rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003436-21 Sponsor Protocol Number: D2450174 Start Date*: 2005-10-26
    Sponsor Name:Dainippon Sumitomo Pharma Europe Ltd
    Full Title: A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (D...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000109-11 Sponsor Protocol Number: FKB327-002 Start Date*: 2015-01-22
    Sponsor Name:Fujifilm Kyowa Kirin Biologics Co., Ltd.
    Full Title: A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BG (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-014300-55 Sponsor Protocol Number: MTXIFODepocyte Start Date*: 2010-04-14
    Sponsor Name:Charité-Universitätsmedizin Berlin
    Full Title: Phase II study on the combined systemic and intrathecal chemotherapy with methotrexate, ifosfamide and liposomal cytarabine (DepoCyte®) in patients with HER-2/neu-negative breast cancer and leptome...
    Medical condition: HER-2/neu-negative breast cancer with leptomeningeal spread
    Disease: Version SOC Term Classification Code Term Level
    12.0 10027475 Metastatic breast cancer LLT
    12.0 10024233 Leptomeningeal metastases LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-003771-37 Sponsor Protocol Number: Hx-CD20-403 Start Date*: 2006-03-03
    Sponsor Name:Genmab A/S
    Full Title: A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthrit...
    Medical condition: Active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    7.0 10039073 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2010-024516-34 Sponsor Protocol Number: CAIN457F2206 Start Date*: 2011-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to pl...
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) IT (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-001863-39 Sponsor Protocol Number: ML27837 Start Date*: 2011-07-28
    Sponsor Name:Roche Austria GmbH
    Full Title: A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheum...
    Medical condition: Mild to moderate rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2008-004931-39 Sponsor Protocol Number: ALD518-CLIN-003 Start Date*: 2008-12-08
    Sponsor Name:Alder Biopharmaceuticals, Inc
    Full Title: A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid ...
    Medical condition: Active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-006917-25 Sponsor Protocol Number: A3003RA Start Date*: 2009-04-24
    Sponsor Name:Nuon Therapeutics, Inc.
    Full Title: A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).
    Medical condition: Patients with active rheumatoid arthritis who are on a stable dose of methotrexate
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) CZ (Completed) GB (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001165-24 Sponsor Protocol Number: UC-0150/1704 Start Date*: 2018-06-12
    Sponsor Name:UNICANCER
    Full Title: A Multicentre, Randomised, Open-label, Phase 2 trial of mifamurtide combined with post-operative chemotherapy for newly diagnosed high risk osteosarcoma patients (metastatic osteosarcoma at diagnos...
    Medical condition: Patients ≤50 years old with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response) after pre-operative chemotherapy and s...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004194-51 Sponsor Protocol Number: 020520 Start Date*: Information not available in EudraCT
    Sponsor Name:Medical University of Lodz
    Full Title: A prospective, randomized, phase III open-label clinical trial with blinded end-point assessment to evaluate the efficacy and safety of cyclosporine and methotrexate in children and adolescent subj...
    Medical condition: Atopic dermatitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-002067-20 Sponsor Protocol Number: RA0077 Start Date*: 2012-06-13
    Sponsor Name:UCB Pharma SA
    Full Title: A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subject...
    Medical condition: Moderate to severe rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004859 10003268 Arthritis rheumatoid LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) HU (Completed) PT (Completed) AT (Completed) IE (Completed) CZ (Completed) ES (Completed) BG (Completed) FR (Completed) IT (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004834-11 Sponsor Protocol Number: CR6086-2-02 Start Date*: 2017-07-06
    Sponsor Name:Rottapharm Biotech S.r.l.
    Full Title: A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 o...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BG (Completed) PL (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-019514-24 Sponsor Protocol Number: M12-073 Start Date*: 2011-04-04
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis.
    Medical condition: Rheumatoid Arthritis.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) CZ (Completed) AT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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