[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652004":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":35,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":11,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Khyber Teaching Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RITUXIMAB","EXPERIMENTAL",null,[13],"Drug: Rituxan (rituximab)",{"label":15,"type":16,"description":11,"interventionNames":17},"CORTICOSTEROIDS PLUS AZATHIOPRINE","ACTIVE_COMPARATOR",[18],"Drug: Azathioprine (AZA)' plus corticosteroids",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Rituxan (rituximab)","a biological drug plus corticosteroids in the treatment of P.V",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Azathioprine (AZA)' plus corticosteroids","A CONVRNTIONAL TREATMENT FOR P.V",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"NOOR AYAZ, MBBS","CONTACT","+923345536315","drnoorayaz@gmail.com",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Noor Ayaz","DR","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":50,"type":51},92,"ESTIMATED","INTERVENTIONAL",[54],"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.",[57,58],"Pemphigus Vulgaris","Rituximab (RTx)","NOT_YET_RECRUITING","2026-08-15",{"date":62,"type":63},"2026-08-18","ACTUAL",{"date":65,"type":51},"2026-12-02",{"date":67,"type":51},"2027-11-06",{"name":5,"class":6}]