NCT07252271Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
Objective To investigate the efficacy of prednisolone 4mg/day added to standard of care in newly diagnosed rheumatoid arthritis (RA) patients with active disease. Hypothesis Add-on prednisolone 4mg/day is efficacious compared to placebo in newly diagnosed RA patients with active disease. Design 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/week 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. Study 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. Main 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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07252271
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 112
- From 1 Dec 2025 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnancy or premenopausal women planning pregnancy
- Functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
- Use of systemic GC in recent one month
- Contraindications to prednisolone
Who the study is looking for
- ≥18 year-old
- Fulfilment of the 2010 ACR/EULAR classification criteria of RA
- Never use of any DMARDs for RA -
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.