[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612337":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":26,"enrollmentInfo":44,"targetDuration":26,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":26,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":26},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"very low dose prednisolone","ACTIVE_COMPARATOR","Randomization will be performed using a computer-generated randomization list provided by the research pharmacist, adopting a permuted blocks design with block sizes of 4. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes. Treatment will be masked to patients and investigators. The participants will be instructed to take the study drugs daily for 10 weeks. For the prednisolone group, the dose of the active drug will be 4mg once daily for 4 weeks then tapering at 1mg\u002Fweek every 2-week till off at week 10.",[13],"Drug: Prednisolone",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Randomization will be performed using a computer-generated randomization list provided by the research pharmacist, adopting a permuted blocks design with block sizes of 4. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes. Treatment will be masked to patients and investigators. The participants will be instructed to take the study drugs daily for 10 weeks.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Prednisolone","The dose prednisolone will be 4mg once daily for 4 weeks then tapering at 1mg\u002Fweek every 2-week till off at week 10.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","The dose of placebo will be 4mg once daily for 4 weeks then tapering at 1mg\u002Fweek every 2-week till off at week 10.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ho SO","Assistant Professor","100612337","phase-4-very-low-dose-prednisolone-on-newly-diagnosed-rheumatoid-arthritis-100612337",false,"NCT07252271","Very Low Dose Prednisolone on Newly Diagnosed Rheumatoid Arthritis","Very Low Dose, add-on Prednisolone in Patients With Newly Diagnosed Rheumatoid Arthritis: a Randomised Placebo-controlled Study","Inclusion Criteria:\n\n1. ≥18 year-old\n2. Fulfilment of the 2010 ACR\u002FEULAR classification criteria of RA\n3. Never use of any DMARDs for RA -\n\nExclusion Criteria:\n\n1. Pregnancy or premenopausal women planning pregnancy\n2. Functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)\n3. Use of systemic GC in recent one month\n4. Contraindications to prednisolone","ALL","18 Years",{"count":45,"type":46},112,"ESTIMATED","INTERVENTIONAL",[49],"PHASE4","Objective To investigate the efficacy of prednisolone 4mg\u002Fday added to standard of care in newly diagnosed rheumatoid arthritis (RA) patients with active disease.\n\nHypothesis Add-on prednisolone 4mg\u002Fday is efficacious compared to placebo in newly diagnosed RA patients with active disease.\n\nDesign and subjects This is a 12-week, randomized, placebo-controlled, double-blind study. We plan to enroll 112 adult patients with newly diagnosed active RA (Disease Activity Score 28-C-Reactive Protein \\[DAS28-CRP\\] \\> 3.2). They will be randomized 1:1 to receive prednisolone 4mg once daily for 5 weeks then tapering at 1mg\u002Fweek each week till off or placebo. Conventional synthetic disease-modifying-anti-rheumatic-drugs (DMARDs) will be started and adjusted according to a standard protocol aiming to achieve low disease activity. Patients with contra-indications to prednisolone, or requiring biologic or targeted synthetic DMARDs will be excluded.\n\nStudy instruments Clinical response will be monitored using DAS28-CRP every 4 weeks. Adverse events (AE), severe AE (SAE) and AE of special interest (AESI) will be recorded at every visit.\n\nMain outcome measures and analysis The primary outcome is the change of DAS28-CRP comparing the two groups at week-4 by student T test. Secondary outcomes include the changes of DAS28-CRP at week-8 and week-12 as well as proportion of patients with AE comparing the two groups. Independent factors predicting disease control will be analyzed by multivariate logistic regression.",[52],"Rhematoid Arthritis","NOT_YET_RECRUITING","2025-11-25",{"date":56,"type":57},"2025-12-02","ACTUAL",{"date":59,"type":46},"2025-12-01",{"date":61,"type":46},"2028-06-30",{"name":5,"class":6}]