[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rituximab-rtx\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rituximab-rtx":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100652004","early-phase-1-effectiveness-of-rituximab-compared-with-standard-therapy-in-moderate-to-severe-pemphigus-vulgaris-100652004",false,"NCT07769333","Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris","Effectiveness of Rituximab With Corticosteroids Versus Standard Oral Corticosteroids Plus Azathioprine in Participants With Moderate-to-Severe Pemphigus Vulgaris: A Quasi-Experimental Study","Inclusion Criteria:\n\n* Adults aged 18-65 years.\n* Active moderate-to-severe pemphigus vulgaris.\n* Newly diagnosed disease or disease flare.\n* Diagnosis confirmed by biopsy and direct immunofluorescence\n\nExclusion Criteria:\n\n* Mild pemphigus vulgaris.\n* Pregnancy or lactation.\n* Active malignancy.\n* Serious infection.\n* Severe cardiac disease.\n* Severe renal disease.\n* Severe hepatic disease.\n* Prior exposure to rituximab within the last 12 months.","ALL","18 Years","65 Years",{"count":20,"type":21},92,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This quasi-experimental study aims to compare the effectiveness and safety of rituximab combined with corticosteroids versus the standard regimen of oral corticosteroids plus azathioprine in patients with moderate to severe pemphigus vulgaris.\n\nPemphigus vulgaris is a rare autoimmune blistering disease. Conventional treatment with high-dose corticosteroids and azathioprine, though effective, is associated with significant long-term side effects. Rituximab, a B-cell depleting monoclonal antibody, has emerged as a promising alternative that may achieve higher rates of complete remission, faster disease control, fewer relapses, and reduced cumulative steroid exposure.\n\nPatients will be allocated non-randomly into two groups based on clinical suitability, affordability, and preference. Outcomes will be assessed over 12 months, focusing primarily on complete remission rates, with secondary evaluation of time to disease control, relapse rates, cumulative corticosteroid dose, and adverse events.\n\nThe study seeks to generate local evidence from Pakistan to guide more effective and safer treatment protocols for moderate to severe pemphigus vulgaris.",[27,28],"Pemphigus Vulgaris","Rituximab (RTx)","NOT_YET_RECRUITING","2026-08-15",{"date":32,"type":33},"2026-08-18","ACTUAL",{"date":35,"type":21},"2026-12-02",{"date":37,"type":21},"2027-11-06",{"name":39,"class":40},"Khyber Teaching Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100585759","phase-4-evaluation-of-200-mg-of-rituximab-every-6-months-as-maintenance-treatment-of-rituximab-treated-patients-with-rheumatoid-arthritis-100585759","NCT06906549","Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis","Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis: a Non-inferiority Prospective Randomised Controlled Trial","RADAR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of rheumatoid arthritis (RA) according to EULAR\u002FACR 2010 classification criteria\n* DAS28 ≤ 5.1\n* Current maintenance treatment with Rituximab regardless of dose and\u002For duration of Rituximab treatment and with at least first cycle of Rituximab ended (2 initial infusions)\n* Last Rituximab infusion between 6 and 18 months prior to inclusion\n* Corticosteroids ≤10 mg\u002Fday within 4 weeks prior to inclusion\n* Affiliation to a social insurance system or beneficiary\n* Written informed consent to participate in the study, dated and signed before starting the trial\n* Effective method of birth control during the study\n\nExclusion Criteria:\n\n* Rheumatic autoimmune disease other than RA (except associated Sjogren's disease, which is allowed)\n* Concurrent treatment with any other targeted therapy than Rituximab\n* Any contraindication to Rituximab or to NaCl 0.9%\n* Significant uncontrolled associated disease or comorbidity\n* Known active infection or history of serious recurrent or chronic infection\n* Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin \\\u003C8 g\u002FdL, neutropenia \\\u003C 1.5G\u002FL, IgM \\\u003C0.4 g\u002FL and\u002For IgG \\\u003C5 g\u002FL\n* Pregnancy, breastfeeding, or planned pregnancy during the study (on subject declaration)\n* Drug addiction, alcohol addiction\n* Patients who cannot be followed for the 12 month-duration\n* Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision\n* Subject in exclusion period (determined by a previous or ongoing study)\n* Patients unable to give informed consent (e.g., patients in a situation of medical emergency, patients who have difficulty comprehending the essential details of the trial...)\n* Patients who have difficulty reading or understanding French, or who have an inability to understand the delivered information",{"count":50,"type":21},260,[52],"PHASE4","Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting joints and causing progressive disability. Current treatment strategies involve conventional disease-modifying anti-rheumatic drugs (csDMARDs) and, in more resistant cases, biologic DMARDs (bDMARDs) such as Rituximab. Rituximab, a monoclonal antibody targeting CD20-positive B cells, is administered as an induction dose followed by maintenance therapy every six months. Standard maintenance dosing consists of 1g infusions, but lower doses may provide equivalent efficacy with fewer side effects.\n\nThe RADAR trial is a multicenter, prospective, randomized, double-blinded, non-inferiority controlled trial designed to evaluate whether a 200 mg maintenance dose of Rituximab every six months is non-inferior to the standard 1g dose in patients with RA who are in low disease activity. The study will assess disease activity using the DAS28-CRP score over 12 months, alongside various secondary endpoints, including treatment failure rates, immune responses, and adverse events.\n\nBy determining the minimum effective Rituximab dose, the study aims to optimize patient safety, reduce the risk of infections, and lower healthcare costs. This trial is particularly relevant as Rituximab has lost patent protection, making cost-effective treatment crucial, especially in low-resource settings. Findings from this study could lead to updated treatment guidelines, benefiting RA patients worldwide.",[55,28],"Rheumatoid Arthritis (RA)",[57,58],"Dose reduction","Low dose Rituximab","RECRUITING","2025-07-18",{"date":62,"type":33},"2025-07-23",{"date":64,"type":33},"2025-07-11",{"date":66,"type":21},"2026-07",{"name":68,"class":40},"University Hospital, Strasbourg, France",1]