Very Low Dose Prednisolone on Newly Diagnosed Rheumatoid Arthritis

NCT07252271 | Not Yet Recruiting Phase 4

• 1 other identifier: VlP
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rhematoid Arthritis

Outcome Measures

Primary Outcomes (1)

• the change of DAS28-CRP at 4 weeks comparing prednisolone group and placebo group.

  DAS28-CRP is a composite score of CRP, patient global VAS, tender joint count and swollen joint count

  4 weeks

Secondary Outcomes (5)

• Changes of RA disease activity (DAS28-CRP) at week-8, week-12 and week 24 comparing the 2 groups.

  24 weeks

• Changes of RA disease activity (DAS28-CRP) at different time points within the 2 groups.

  24 weeks

• Disability at different time points comparing the 2 groups.

  24 weeks

• Proportion of patients with adverse events comparing the 2 groups.

  24 weeks

• Independent predictors of RA disease control in all participants

  24 weeks

Study Arms (2)

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/week every 2-week till off at week 10.

Drug: Prednisolone

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.

Drug: Placebo

Interventions

Prednisolone DRUG

The dose prednisolone will be 4mg once daily for 4 weeks then tapering at 1mg/week every 2-week till off at week 10.

very low dose prednisolone

Placebo DRUG

The dose of placebo will be 4mg once daily for 4 weeks then tapering at 1mg/week every 2-week till off at week 10.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 year-old
• Fulfilment of the 2010 ACR/EULAR classification criteria of RA
• Never use of any DMARDs for RA -

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11