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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 ).  
     
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    1,059 result(s) found for: Methotrexate. Displaying page 4 of 53.
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    EudraCT Number: 2005-002345-39 Sponsor Protocol Number: Göteborg University Start Date*: 2006-02-16
    Sponsor Name:NOPHO NHL-group
    Full Title: B-NHL BFM 04
    Medical condition: B-cell lymphoma or B-ALL in children up to 18 years of age
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003591-19 Sponsor Protocol Number: MC-MTX.10/RH Start Date*: Information not available in EudraCT
    Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH
    Full Title: AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN P...
    Medical condition: 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: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000082-38 Sponsor Protocol Number: HUM05-019 Start Date*: 2007-05-24
    Sponsor Name:Aarhus University Hospital, Denmark
    Full Title: The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid...
    Medical condition: In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as asse...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2009-014824-40 Sponsor Protocol Number: ART621-290 Start Date*: 2009-11-03
    Sponsor Name:Arana Therapeutics Ltd
    Full Title: An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomita...
    Medical condition: Rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003682-26 Sponsor Protocol Number: CF101-301RA Start Date*: 2019-07-11
    Sponsor Name:Can-Fite BioPharma, Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid ...
    Medical condition: Early Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003900-28 Sponsor Protocol Number: TOFA-PREDICT Start Date*: 2018-04-04
    Sponsor Name:UMC Utrecht
    Full Title: A Stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA). TOFA-PREDICT
    Medical condition: psoriatic arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-003733-14 Sponsor Protocol Number: WA17823 Start Date*: 2005-03-23
    Sponsor Name:F. Hoffmann La-Roche Ltd.
    Full Title: A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-012759-12 Sponsor Protocol Number: WA19926 Start Date*: 2009-10-14
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy a...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) DE (Completed) ES (Completed) FI (Completed) FR (Completed) PT (Completed) DK (Completed) IE (Completed) GR (Completed) SE (Completed) IT (Completed) HU (Completed) CZ (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2008-007023-26 Sponsor Protocol Number: A3921044 Start Date*: 2009-05-18
    Sponsor Name:Pfizer Inc.
    Full Title: PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE
    Medical condition: CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GR (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-000522-18 Sponsor Protocol Number: 2016-01 Start Date*: Information not available in EudraCT
    Sponsor Name:PIBDNet
    Full Title: Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive...
    Medical condition: Crohn’s disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) BE (Completed) PL (Ongoing) CZ (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002013-29 Sponsor Protocol Number: TREAT Start Date*: 2016-01-16
    Sponsor Name:Kings College London [...]
    1. Kings College London
    2. Guy's and St Thomas' NHS Foundation Trust
    Full Title: A Randomised Controlled Trial Assessing the Effectiveness, Safety and Cost-effectiveness of Methotrexate versus Ciclosporin in the Treatment of Severe Atopic Eczema in Children: The TREatment of Se...
    Medical condition: severe atopic ezcema
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10003641 Atopic eczema LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001691-39 Sponsor Protocol Number: UKM17_0023 Start Date*: 2019-07-16
    Sponsor Name:University Hospital Münster
    Full Title: LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma
    Medical condition: Lymphoblastic lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10065923 Lymphoblastic lymphoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Ongoing) DK (Trial now transitioned) IE (Completed) NO (Trial now transitioned) FI (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) NL (Ongoing) SK (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004641-33 Sponsor Protocol Number: DIA2020-01 Start Date*: 2021-02-16
    Sponsor Name:Diakonhjemmet Hospital
    Full Title: The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) trial
    Medical condition: Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10016686 Finger osteoarthritis LLT
    21.1 100000004859 10019115 Hand osteoarthritis LLT
    21.0 100000004859 10064565 Erosive osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-004918-18 Sponsor Protocol Number: OPTIMAP Start Date*: 2014-02-03
    Sponsor Name:Academic Medical Center
    Full Title: Optimising adalimumab treatment in psoriasis with concomitant methotrexate.
    Medical condition: psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003780-65 Sponsor Protocol Number: IM133-066 Start Date*: 2014-03-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have ...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10066578 Progression of rheumatoid arthritis LLT
    14.1 100000004859 10060732 Rheumatoid arthritis flare up LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-003594-95 Sponsor Protocol Number: MTXSB2018 Start Date*: 2019-04-30
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response
    Medical condition: Inflammatory bowel disease: Crohn's disease and Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001571-21 Sponsor Protocol Number: P18.037 Start Date*: Information not available in EudraCT
    Sponsor Name:Leiden University
    Full Title: Training immune functions through pharmacotherapeutic conditioning in juvenile idiopathic arthritis
    Medical condition: Juvenile Idiopathic Arthritis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-015403-95 Sponsor Protocol Number: NS10364-3 Start Date*: 2010-02-11
    Sponsor Name:Faculty Hospital Hradec Králové
    Full Title: A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid
    Medical condition: moderate-severe and severe plaque psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003260-20 Sponsor Protocol Number: 20140727 Start Date*: 2016-05-04
    Sponsor Name:Leiden University Medical Centre
    Full Title: CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiop...
    Medical condition: Juvenile idiopathic arthritis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002366-41 Sponsor Protocol Number: AIEOP-ISGOsM+ Start Date*: 2021-09-28
    Sponsor Name:ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    Full Title: Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma
    Medical condition: Metastatic osteosarcoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031294 Osteosarcoma metastatic PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
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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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