[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565973":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":88,"studyPopulation":81,"armGroups":89,"interventions":100,"overallOfficials":81,"centralContacts":106,"locations":115,"responsibleParty":140,"collaborators":143,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":81,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":117,"whyStopped":81,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"CDAI remission (≤2.8) at week 24","The primary endpoint is the achievement of remission defined as the CDAI ≤2.8 assessed 24 weeks after randomisation comparing patients with dose\u002Froute optimization (≥10mg MTX oral weekly switched to 25mg MTX subcutaneously weekly) and oral dose optimization (≥10mg MTX oral weekly switched to 25mg MTX oral weekly).","24 weeks",[14,17,21,24,27,30,33,36,39,42,45,46,49,50,53],{"measure":15,"description":16,"timeFrame":12},"CDAI low disease activity (≤10) at week 24","To assess the proportion of patients in CDAI low disease activity (≤10) at week 24",{"measure":18,"description":19,"timeFrame":20},"CDAI remission (≤2.8) at week 12","To assess the proportion of patients in CDAI remission (≤2.8) at week 12","12 weeks",{"measure":22,"description":23,"timeFrame":20},"CDAI low disease activity (≤10) at week 12","To assess the proportion of patients in CDAI low disease activity (≤10) at week 12",{"measure":25,"description":26,"timeFrame":12},"ACR20% response at week 24","To assess the proportion of patients achieving an ACR20% response at week 24",{"measure":28,"description":29,"timeFrame":20},"ACR20% response at week 12","To assess the proportion of patients achieving an ACR20% response at week 12",{"measure":31,"description":32,"timeFrame":12},"ACR50% response at week 24","To assess the proportion of patients achieving an ACR50% response at week 24",{"measure":34,"description":35,"timeFrame":20},"ACR50% response at week 12","To assess the proportion of patients achieving an ACR50% response at week 12",{"measure":37,"description":38,"timeFrame":12},"ACR70% response at week 24","To assess the proportion of patients achieving an ACR70% response at week 24",{"measure":40,"description":41,"timeFrame":20},"ACR70% response at week 12","To assess the proportion of patients achieving an ACR70% response at week 12",{"measure":43,"description":44,"timeFrame":12},"Patient reported outcomes on NRS","Difference in change (absolute and relative) of patient reported outcomes on numeric response scale (NRS), including pain, patient global assessment, and joint stiffness between the treatment groups between baseline and week 24",{"measure":43,"description":44,"timeFrame":20},{"measure":47,"description":48,"timeFrame":12},"Quality of Life questionnaires","Difference in change (absolute and relative) of patient reported outcomes measured by questionnaires:\n\n1. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)\n2. the 36-Item Short Form Survey version 1 (SF36v1)\n3. The Health Assessment Questionnaire Disability Index (HAQ-DI) between the treatment groups between baseline and week 12",{"measure":47,"description":48,"timeFrame":20},{"measure":51,"description":52,"timeFrame":12},"Joint count and inflammatory markers","Difference in change (absolute and relative) of swollen joint count, tender joint count and CRP\u002FESR between baseline and week 24",{"measure":51,"description":54,"timeFrame":20},"Difference in change (absolute and relative) of swollen joint count, tender joint count and CRP\u002FESR between baseline and week 12",[56,60,63,66,69,72,75],{"measure":57,"description":58,"timeFrame":59},"MTX-PGs levels and CDAI response","Association of MTX-PGs levels and CDAI response at week 12 and week 24","week 12 and 24",{"measure":61,"description":62,"timeFrame":59},"Therapeutic drug monitoring (MTX metabolites, TTV)","Association of MTX dosage, MTX-PGs levels and torque teno virus titer as a potential marker to guide levels of immunosuppressive therapy at week 12 and week 24",{"measure":64,"description":65,"timeFrame":59},"Finger sweat analysis","Association of MTX-metabolites and inflammatory markers in finger sweat analysis and CDAI at week 12 and week 24",{"measure":67,"description":68,"timeFrame":12},"Cumulative glucocorticoid dose","Difference in cumulative glucocorticoid (GC) dose between treatment arms",{"measure":70,"description":71,"timeFrame":12},"Treatment adherence","Association of CDAI response and treatment adherence as measured by paper-based questionnaires, methotrexate metabolites and electronic adherence monitoring (in patients using the RheumaBuddy mobile app)",{"measure":73,"description":74,"timeFrame":12},"Safety profile","Differences in safety profile according to number of adverse events and organ systems (haematologic, hepatic, gastrointestinal, infections)",{"measure":76,"description":77,"timeFrame":12},"Trajectories of disease activity","Trajectories of disease activity in the two groups over all visits, and its relation to predictors",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":81,"timePerspective":81,"maskingInfo":83},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":84,"maskingDescription":85,"whoMasked":86},"SINGLE","joint assessor blinding",[87],"OUTCOMES_ASSESSOR","Methotrexate is recommended as the first-line therapy in patients with rheumatoid arthritis. However, a significant proportion of patients does not achieve disease remission with methotrexate monotherapy, which can be attributed to multiple reasons. We hypothesize, that the efficacy limitations of this well-known medication can be, to some extent, overcome by sufficient dose and route optimisation. Furthermore, individual factors effecting the treatment response are unknown. Thus, we aim to evaluate the \"maximised methotrexate therapy\" before switching to biologic or targeted synthetic drugs.\n\nThe MethMax trial is a prospective, randomised, assessor-blinded, parallel-group, low-intervention trial, including 182 patients across 7 European countries. Patients with active rheumatoid arthritis, naïve to biologic or targeted synthetic antirheumatic drugs, who have been on a stable oral methotrexate therapy for the past 3 months will be randomised in 1:1 ratio to either 25 mg oral or 25 mg subcutaneous methotrexate weekly. In both arms, a short glucocorticoid therapy will be prescribed at baseline visit. The active study duration for each patient is 24 weeks. After inclusion, study visits take place at baseline, weeks 4, 12, 16 and 24. The clinical efficacy and safety parameters will be obtained at each visit. At predefined timepoints, further patient reported outcomes, exploratory biomarkers like sweat and blood metabolites, as well as medication adherence will be assessed. Written consent will be obtained for all participants. The study has received regulatory approval via the Clinical Trials Information System and hasstarted recruitment in August 2024.\n\nThe anticipated results will suggest whether the subcutaneous administration of 25 mg methotrexate weekly is superior to oral methotrexate 25 mg and lower doses in each route respectively. The outcomes include clinical disease activity, methotrexate metabolism analyses and medication adherence. The gained knowledge could lead to individual therapy optimisation and new therapy recommendations.",[90,96],{"label":91,"type":92,"description":93,"interventionNames":94},"methotrexate 25mg s.c.","ACTIVE_COMPARATOR","methotrexate 25mg s.c. weekly dose",[95],"Drug: Methotrexate",{"label":97,"type":92,"description":98,"interventionNames":99},"methotrexate 25mg p.o.","methotrexate 25mg p.o. weekly dose",[95],[101],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":81},"DRUG","Methotrexate","comparison between oral and subcutaneous methotrexate dosis of 25mg",[97,91],[107,112],{"name":108,"role":109,"phone":110,"phoneExt":81,"email":111},"Helga Lechner-Radner, Assoc.- Prof., PD, MD","CONTACT","+43 1 40400 47313","helga.lechner-radner@meduniwien.ac.at",{"name":113,"role":109,"phone":81,"phoneExt":81,"email":114},"Karolina Anderle, MD","karolina.anderle@meduniwien.ac.at",[116],{"facility":5,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"RECRUITING","Vienna","State of Vienna","1090","Austria","AT",{"type":124,"coordinates":125},"Point",[126,127],16.37208,48.20849,{"lat":127,"lon":126},[130,133,135,138],{"name":131,"role":109,"phone":132,"phoneExt":81,"email":111},"Helga Lechner-Radner, MD","+43 (0)1 40400-43071",{"name":134,"role":109,"phone":132,"phoneExt":81,"email":114},"Karolina Anderle, MD, Assoc.-Prof.",{"name":136,"role":137,"phone":81,"phoneExt":81,"email":81},"Helga Lechner-Radner, MD, Assoc.-Prof.","PRINCIPAL_INVESTIGATOR",{"name":113,"role":139,"phone":81,"phoneExt":81,"email":81},"SUB_INVESTIGATOR",{"type":137,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"Helga Lechner-Radner","Assoz. Prof., Priv.-Doz. Dr.",[144,146,148,151,153,155],{"name":145,"class":6},"Leiden University Medical Center",{"name":147,"class":6},"Queen Mary University of London",{"name":149,"class":150},"Carol Davila University of Medicine and Pharmacy, Clinical Centre for Rheumatic Diseases, Bucharest","UNKNOWN",{"name":152,"class":150},"Humanitas Mirasole S.p.A. - Instituto Clinico Humanitas (ICH), Rozzano (Milan)",{"name":154,"class":150},"Region Stockholm, Solna",{"name":156,"class":150},"Diakonhjemmet Hospital AS (DH), Oslo","100565973","phase-4-methmax-trial-maximising-the-methotrexate-therapy-potential-in-patients-with-active-rheumatoid-arthritis-100565973",false,"NCT06649136","MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients With Active Rheumatoid Arthritis","An International, Multicentre, Interventional, Randomised, Assessor-blinded Trial to MAXimise the METHotrexate Therapy Potential in Patients With Active Rheumatoid Arthritis","MethMax","Inclusion Criteria:\n\n1. Men and women, ≥ 18 years of age, capable of understanding and signing an informed consent (including sufficient literacy and proficiency in the local language) and following the study procedures\n2. Patients with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) classification criteria\n3. Ongoing conventional therapy with oral methotrexate (between ≥10mg and 25mg weekly) for ≥3 months with stable dosing, and clinical and laboratory tolerance of this treatment for at least 12 weeks\n4. CDAI \\> 2.8 + at least 1 clinically swollen joint (on 28-Joint count)\n5. Willingness to increase methotrexate dosing and change the route of administration according to study procedures\n\nExclusion Criteria:\n\n1. Inflammatory rheumatic diseases other than RA\n2. Ongoing or previous therapy with any targeted synthetic DMARDs (tsDMARD) or biological Disease-Modifying Anti-Rheumatic Drug (bDMARD) with the exception of any TNFα inhibitor in a stable dose and interval for at least 4 months; We allow ongoing or previous therapy with a conventional synthetic DMARD (csDMARD) with a stable dose in the past 4 months.\n3. Use of GC unless on stable oral dose ≤10mg for at least 4 weeks prior to study inclusion\n4. Patients using NSAIDs, unless taken at a stable dose for ≥2 weeks prior to study inclusion\n5. Intraarticular GC treatment in the last 8 weeks\n6. Patients with significant and clinically relevant MTX-drug toxicity as judged by the investigator\n7. Elevated liver enzymes (aspartate transaminase (ASAT) and\u002For alanine transaminase (ALAT)), and\u002For alkaline phosphatase (AP), and\u002For gamma-glutamyl transferase (GGT) above 2x the upper limit normal (ULN)\n8. Reduced kidney function (glomerular filtration rate (GFR)\\\u003C60)\n9. Haematologic abnormalities (grade 2 or 3: anaemia, leukopenia, thrombocytopenia)\n10. Stomatitis under the treatment with MTX\n11. Known history of recurrent\u002Fserious infections in the previous two months (such as, but not limited to, hepatitis, pneumonia, or pyelonephritis)\n12. A positive HBsAg and\u002For HCV test at screening visit\n13. Ongoing or recurring opportunistic infections (e.g., herpes zoster, cytomegalovirus, pneumocystis, aspergillosis, histoplasmosis, or mycobacteria) as judged by the investigator\n14. Women of childbearing potential without the use of adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) and willing to continue this precaution for the duration of the study until 6 months after receiving the last medication\n15. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, as judged by the investigator\n16. Being unable or unwilling to undergo multiple venepunctures because of poor tolerability or lack of sufficient venous access\n17. Being unwilling or unable to perform s.c injections\n18. Presence of a transplanted solid organ (with the exception of a corneal transplant \\> 3 months prior to screening)\n19. Women who are pregnant, nursing; or planning pregnancy during the study and 6 months after the individual study completion\n20. History of alcohol or substance abuse within the preceding 6 months\n21. Any medical or psychological condition that, judged by the investigator, would interfere with safe completion of the trial\n22. Immunisation with a live\u002Fattenuated vaccine within 12 weeks prior to baseline or potential need to receive a live vaccine during the course of the study\n23. Active participation in any other interventional study","ALL","18 Years","99 Years",{"count":169,"type":170},182,"ESTIMATED","INTERVENTIONAL",[173],"PHASE4","The MethMax trial is a prospective, international, multicentre, randomised, assessor-blinded, parallel-group, low intervention study. Patients with active rheumatoid arthritis treated with oral methotrexate up to 25 mg weekly will be randomised in 50:50 fashion to receive 25 mg oral vs subcutaneous methotrexate for the period of 24 weeks. In regular visits, patient reported outcomes, clinical disease activity, therapy adherence and diverse established and exploratory biomarkers will be assessed.",[176],"Rheumatoid Arthritis",[178,179,180,181],"rheumatoid arthritis","methotrexate","therapy adherence","biomarker","2026-10-01",{"date":184,"type":185},"2026-10-06","ACTUAL",{"date":187,"type":185},"2024-08-12",{"date":189,"type":170},"2027-06-07",{"name":5,"class":6},1]