[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"methotrexate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:methotrexate":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,85,114,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100589912","phase-3-perioperative-durvalumab-with-neoadjuvant-ddmvac-or-gemcitabinecisplatin-in-patients-with-muscle-invasive-bladder-cancer-niagara-2-100589912",false,"NCT06960577","Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine\u002FCisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem\u002FCis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)","Inclusion Criteria:\n\n* Participants with clinical tumour stage T2-T4aN0\u002F1M0 or T1N1M0 with transitional or mixed transitional cell histology\n* Patients must be planning to undergo radical cystectomy\n* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer\n* ECOG performance status of 0 or 1\n* Minimum life expectancy of 12 weeks at first dose of study medication\n\nExclusion criteria:\n\n* Evidence of lymph node (N2-N3) or metastatic (M1) disease\n* Inoperable tumour(s) with fixation to the pelvic wall on clinical examination\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem\u002Fcis).\n* Uncontrolled intercurrent illness.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine\u002Fcisplatin) in a clinical practice setting.",[26,27,28,29,30,31,32],"Urinary Bladder Neoplasms","Immune Checkpoint Inhibitors","Methotrexate","Vinblastine","Doxorubicin","Cisplatin","Gemcitabine",[34,35,36,37,38,39,32,31],"Muscle-invasive Bladder Cancer","Bladder Cancer","Immunotherapy","Durvalumab","Perioperative Durvalumab","ddMVAC","RECRUITING","2026-06-10",{"date":43,"type":44},"2026-06-11","ACTUAL",{"date":46,"type":44},"2025-05-15",{"date":48,"type":20},"2028-10-31",{"name":50,"class":51},"AstraZeneca","INDUSTRY",59,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100605347","phase-2-role-of-methotrexate-in-ultrasound-proven-synovitis-in-primary-knee-oa-100605347","NCT07161336","Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA","Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis : A Randomized Controlled Trial","MTX in knee OA","Inclusion Criteria:\n\n* Men and women aged between 40 to 70 years\n* Patients fulfilling American College of Rheumatology (ACR) clinical and radiological criteria for knee OA. (knee pain + at least 3 of 5 that not including \"no palpable warmth\")\n* Knee pain on most days for at least 6 months, with a pain VAS of at least 40mm\n* Radiological grading of OA with Kallgren-Lawrence grade of 2 to 3\n* Patients with the presence of knee synovitis in Musculoskeletal ultrasound\n\nExclusion Criteria:\n\n* Any known inflammatory arthritis\n* BMI \\>= 40 kg\u002Fm2\n* Abnormal renal (e.g. abnormal renal function Creatinine clearance \\\u003C35 ml) hepatic (including active hepatitis B, hepatitis C, abnormal liver function), hematological (e.g. white cell count \\\u003C 4 × 109\u002FL, platelets \\\u003C100 ×109\u002FL, or hemoglobin \\\u003C 9 g\u002FdL), function\n* Use of intra-articular, intramuscular or oral corticosteroids in previous 4 weeks\n* History knee joint surgery, Charcot joint\n* Severe valgus knee deformity (angle of genu valgum \\> 30°)\n* Use of any disease modifying agents (e.g. hydroxychloroquine or sulfasalazine) in previous 3 months\n* Allergic to MTX\n* Pregnant or lactating women","40 Years","70 Years",{"count":64,"type":20},70,[66],"PHASE2","Background:\n\nOsteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain.\n\nObjectives:\n\nTo assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis.\n\nMethods:\n\nThis randomized Controlled trial will be conducted in the department of Rheumatology, Bangladesh Medical University (BMU) from July 2025 to June 2026. A total of 70 patients will be enrolled with primary knee OA diagnosed on the basis of ACR Criteria for Knee OA with informed written consent. MSK USG examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by a rheumatologist expert in MSK US. Then randomization will be done into group A and group B following a randomization table, each consisting of 35 patients. Consecutive sampling techniques will be followed. One group will receive MTX (start with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated) and Both groups of patients will be allowed to take NSAIDs on a requirement basis with documentation and follow non-pharmacological treatment of OA. At the end of 3rd and 6th month pain and functional status will be assessed by WOMAC, VAS and quality of life will be assessed by using Bangla version of SF-12. At the end of 6th month improvement of synovitis will be seen by MSK USG of involved knees with OMERACT scoring. Primary endpoint for efficacy will be assessed at the end of 24th week by WOMAC. Secondary endpoints will be determined by VAS and SF-12. Adverse effects will be assessed by history, physical examinations and investigations. The data will be analyzed by using the latest version SPSS software (Version 29). Results will be recorded using means and standard deviations. Results will be compared among two groups with a 95% confidence interval and a p- value of \\\u003C 0.05 will be considered statistically significant. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test if there is skewed distribution. Qualitative data in between groups will be analyzed by the chi square test. Probabilities of associations will be assessed by calculating Pearson's rank correlation coefficient. P-value \\\u003C0.05 will be regarded as statistically significant. The nature, purpose and implication of the study as well as the entire spectrum of benefits and risks of study will be explained to the patients. Privacy and confidentiality of the subject will be maintained. Each patient will enjoy the right to participate and or withdraw from the study at any point of the study period. Ethical clearance will be obtained from the institutional Review Board (IRB) of BMU.",[69,70,28],"Osteo Arthritis of the Knee","Synovitis of Knee",[72,73,28],"knee OA","synovitis","2025-09-07",{"date":76,"type":44},"2025-09-12",{"date":78,"type":44},"2025-07-30",{"date":80,"type":20},"2026-08-30",{"name":82,"class":83},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":84},"100599814","efficacy-and-safety-of-resveratrol-in-patients-with-rheumatoid-arthritis-100599814","NCT07089381","Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.","Inclusion Criteria:\n\n* Adult patients \\> 18 years old\n* Established diagnosis of RA according to American College of Rheumatology\u002FEuropean league Against Rheumatism (ACR\u002FEULAR) 2010 criteria (Aletaha et al., 2010), presented with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \\>3.2.\n* Patients receiving stable regimen of one or more csDMARDs for at least the past 3 months.\n* RA Patients with Moderate or high disease activity identified as disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \\>3.2.\n\nExclusion Criteria:\n\n* Patients receiving biologic DMARDs therapy for RA\n* Patients taking any other anti-inflammatory drugs\n* Patients taking any other antioxidants\n* Pregnant and lactating women\n* Other rheumatological, inflammatory diseases or malignancies\n* Smokers\n* Thyroid illnesses\n* Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits), impaired kidney functions (estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin)",{"count":92,"type":20},118,[94],"NA","The aim of the current study is to evaluate the effects of resveratrol on the clinical outcome(s) of patients with moderate rheumatoid arthritis.\n\nObjectives :\n\n1. To investigate the effects of Resveratrol on inflammation and oxidative stress by measuring:\n\n   * Serum Sirtuin 1(SIRT1)\n   * Serum Myeloperoxidase (MPO)\n   * Serum C-reactive protein (CRP)\n2. To investigate the effects of Resveratrol on disease activity by measuring the disease activity (DAS28 score).\n3. To investigate the effect of Resveratrol on improving the quality of life using the Health Assessment Questionnaire Disability index (HAQ-DI).\n4. To assess any adverse effects related to Resveratrol.\n\nPatients:\n\nEligible patients (no=118) will be randomly assigned in a 1:1 ratio to one of two groups:\n\n1. Control group: 59 patients will receive the standard treatment for management of RA for 3 months.\n2. Resveratrol group: 59 patients will receive the standard treatment for management of RA in addition to Resveratrol 1 gm daily, (Organix Egypt) (given as one 1000 mg tablets once daily) for 3 months.",[97,98,99,100,101,102,103,28,104],"Rheumatic Arthritis","Rheumatoid Arthritis (RA) Prevention","Inflamation","Antioxidant","Anti Oxidative Stress","Anti Aging","C Reactive Protein","Quality of Life Outcomes","2025-07-21",{"date":107,"type":44},"2025-07-28",{"date":109,"type":20},"2025-08-01",{"date":111,"type":20},"2026-06-01",{"name":113,"class":83},"Ain Shams University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":84},"100442367","phase-3-comparison-of-azathioprine-to-methotrexate-in-combination-therapy-with-adalimumab-in-crohns-disease-an-open-label-randomized-controlled-trial-100442367","NCT05040464","Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial","COMET","Inclusion Criteria:\n\n* Male or female patients with age \\> 18 years\n* Crohn's disease for at least 6 weeks,\n* Clinically active with CDAI \\> 150\n* Active inflammation by endoscopy (CDEIS \\> 4) at baseline\n* Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab\n* Patient followed in a center belonging to the GETAID network\n* Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.\n* Written consent\n\nExclusion Criteria:\n\n* Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (\\\u003C3 months)\n* Non-passable colonic stricture\n* Previous intolerance to thiopurines or MTX\n* Previous exposition to adalimumab\n* Contra-indication to immunosuppressants or anti-TNF\n* Others serious simultaneous illness that could interfere with study participation\n* Planning pregnancy, pregnancy or lactation or absence of contraception\n* Known substance abusers\n* Use of any investigational drug within 30 days\n* Adults protected by law",{"count":122,"type":20},166,[23],"Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.\n\nThe investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.",[126,127,28],"Crohn Disease","Azathioprine",[126,129,130,131,132],"Combinations of therapy","anti-Tumor Necrosis Factor","azathioprine","methotrexate","2025-05-22",{"date":135,"type":44},"2025-05-28",{"date":137,"type":44},"2021-08-26",{"date":139,"type":20},"2027-05",{"name":141,"class":83},"Centre Hospitalier Universitaire, Amiens",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":149,"minAge":150,"maxAge":61,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":84},"100558695","local-vs-systemic-methotrexate-in-management-of-uterine-ectopic-pregnancy-100558695","NCT06554470","Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy","Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial","Inclusion Criteria:\n\n* Age from 20 to 40 years.\n* Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).\n* Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU\u002FmL.\n\nExclusion Criteria:\n\n* Patients with basal beta hCG levels less than 1500 mIU\u002FMl.\n* Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia\n* Diabetes mellitus.\n* Severe vaginal bleeding or hemodynamic changes or hemoperitoneum.\n* History of cancer.\n* Ascites.\n* Pleural effusion.","FEMALE","20 Years",{"count":152,"type":20},34,[94],"This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.",[156,157,28,158],"Local","Systemic","Uterine Ectopic Pregnancy","2024-08-15",{"date":161,"type":44},"2024-08-16",{"date":159,"type":44},{"date":164,"type":20},"2025-07-01",{"name":166,"class":83},"Tanta University"]