Health TrialsbyHealthPanel

Very Low Dose Prednisolone on Newly Diagnosed Rheumatoid Arthritis

ConditionRhematoid Arthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 year-old

Fulfilment of the 2010 ACR/EULAR classification criteria of RA

Never use of any DMARDs for RA -

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: very low dose prednisoloneActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
4 weeks

Secondary outcomes

1

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

Disease activity will be monitored at Week 4, Week 8, Week 12, and Week 24.

Time frame
24 weeks
2

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

Disease activity will be monitored at Week 4, Week 8, Week 12, and Week 24.

Time frame
24 weeks
3

Disability at different time points comparing the 2 groups.

Functional disability is assessed by the disability index of HAQ (0-3=most functional disability) at week 4, week 8, week 12 and week 24. Comparison will be made between prednisolone and placebo group. The disability in terms of HAQ at different time points comparing the 2 groups, will be analyzed by T-test.

Time frame
24 weeks
4

Proportion of patients with adverse events comparing the 2 groups.

We will record all adverse events (AEs) and, if necessary, make treatment adjustments in accordance with the protocol. Serious AEs (SAEs) are defined as the occurrence of life-threatening condition or death, a significant or permanent disability, a malignancy, hospitalization or prolongation of hospitalization, a congenital abnormality, or a birth defect. AEs of special interest (AESI) will also be collected which include any AE leading to drug discontinuation, MACE (myocardial infarction, cerebrovascular or peripheral arterial vascular event), newly occurring hypertension/diabetes/infection/cataract/glaucoma and fragility fracture. To address the secondary outcome of comparison of proportion of patients with AE in the 2 groups, Chi-square test will be performed and cross-checked by generalized estimating equation (GEE) analysis.

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

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