EFFICACY OF ORAL PREDNISONE VERSUS INTRAMUSCULAR DEPOT METHYLPREDNISOLONE ACETATE FOR REDUCTION OF DISEASE ACTIVITY IN EARLY RHEUMATOID ARTHRITIS WITH MODERATE TO SEVERE DISEASE ACTIVITY: A DOUBLE-BLIND EXPLORATORY RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a double-blind, double dummy RCT to compare the efficacy of oral prednisone versus IM MPS in RA with moderate-high disease activity. The eligible patients will be recruited to either oral prednisone (with IM placebo) arm or IM MPS (with oral placebo) arm. The placebo being used is oral mutivitamin tablets for prednisone and normal saline in sealed sterile vials for IM MPS. The dose of treatment will be low-dose (7.5 mg of prednisone or 80mg of depomedrol) as per standard of care for RA. All patients will be given DMARDs as per institute policy, initiating from methotrexate, and adjusting dose as per treat-to-target policy. The disease activity and other measures will be followed up every 3 monthly or more frequently, as per disease activity of the patient. Any increase in disease activity requiring steroids during the trial duration will be treated with low-dose steroids as per arm of the patient, along with the placebo, to maintain blinding. All adverse effects will also be followed up. Primary outcome will be assessed at 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged 18–70 years diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria.
- •Active disease defined by a Disease Activity Score-28 (DAS28) of >3.
- •Willingness to participate and provide written informed consent.
排除标准
- •Those patients already in remission, as per ACR/EULAR provisional definition of remission.
- •Platelet count < 100,000/µl (risk of intramuscular hematoma)
- •Active tuberculosis
- •Congenital or acquired immunodeficiency (including human immunodeficiency virus)
- •Chronic infection or infections requiring antimicrobial therapy within 1 month.
- •Concurrent presence of other autoimmune disorders
- •Current or past diagnosis of malignancy
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Life expectancy of fewer than 2 years for any reason.
研究者
Sryla P B
All India Institute of Medical Sciences, Rishikesh
