STeroid Options for RA Management (STORM-RA): Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares: A Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- Rheumatoid Arthritis Flare Questionnaire (RA-FQ)
研究概览
简要总结
People living with rheumatoid arthritis (RA) often experience flares-periods where their symptoms suddenly get worse. These flares can cause significant pain, make it harder to move and do daily activities, and lower overall quality of life. Doctors often treat flares with medications called glucocorticoids (GCs), which reduce inflammation. These medications can be taken by mouth (oral/PO) or given as a single injection into the muscle (intramuscular/IM). However, it's not clear which option works better from the patient's point of view-especially when it comes to relief of symptoms, improvements in function, and satisfaction with treatment. Most research so far has focused on how well the drugs control the disease, rather than how they impact the patient's overall experience.
Research Questions:
- Does a single GC injection work just as well as taking pills over a few weeks in improving symptoms reported by patients?
- How do the two treatments compare in terms of symptom relief, ability to function, and patient satisfaction?
- What do patients think and feel about using GCs to treat RA flares?
What the Investigators Think:
The investigators believe that a one-time GC injection is just as good as taking pills for a few weeks when it comes to managing RA flares. In fact, the injection might even be safer and preferred by patients.
What the Investigators are Doing:
The investigators will study 220 adults with RA who are currently having a flare (with at least 3 swollen and tender joints). These patients will be recruited from rheumatology clinics at the University of Toronto and must not have used GCs in the past month. They will be randomly assigned to receive either:
A single injection (Methylprednisolone 120 mg), or Oral pills (Prednisone starting at 15 mg daily and tapering down over 3 weeks).
The main thing the investigators will look at is how much better patients feel after 6 weeks, based on a questionnaire designed to measure RA flares. The investigators will also look at how well they function, how satisfied they are with the treatment, and whether they had any side effects.
In addition, 20 patients (10 from each group) will be interviewed to understand their experiences and opinions about flare treatment in more detail.
Why This Is Possible:
The investigators have already surveyed University of Toronto rheumatologists who support the idea and provided input on study design. The investigators have also partnered with experts in research methods, national arthritis organizations, and patient groups to make sure the study is relevant and meaningful. Ethics approval has been obtained.
Why It Matters:
RA flares can have a major impact on people's lives. While current treatments help control inflammation, the investigators need to better understand how these treatments affect people from their own perspective. This study will shift the focus to what matters most to patients, helping doctors and patients choose the best treatment based not only on medical results but also on the patient's experience. This could lead to more effective and personalized care for people living with RA.
详细描述
Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that can severely impact patients' quality of life, with acute flares being a major challenge (1). These flares lead to pain, swelling, and functional limitations, affecting both physical and emotional well-being, and often result in treatment escalation and long-term complications (2,3). Despite their frequency, there is a gap in understanding optimal management strategies, particularly regarding glucocorticoid (GC) therapy.
Current guidelines recommend oral glucocorticoids (PO GC) as the standard treatment, typically as a tapering regimen, but intra-muscular (IM) injections are also used in practice (4,5). However, there is no direct comparison of their short-term effectiveness, safety, and patient experience. Without this evidence, clinicians lack guidance on which method best suits individual patients, especially regarding flare severity and disease activity.
Understanding the patient experience during RA flares is critical in guiding clinical decision-making. While disease activity measurements, such as the Disease Activity Score (DAS28), are commonly used to assess treatment response, they do not capture the full spectrum of the patient's lived experience during a flare. Patient-reported outcomes (PROs), including pain, fatigue, and overall well-being, are integral to understanding how patients perceive their condition and treatment efficacy (6). Incorporating PROs into clinical trials and practice will not only provide a more holistic view of treatment response but will also help to align these subjective experiences with traditional objective measures of disease activity (7). As such, evaluating the impact of different GC treatments on PROs is essential to determining the most effective approach for managing RA flares and improving patient outcomes.
This study aims to address this gap by conducting a comparative study of IM versus PO steroids for acute RA flare management, with a focus on patient reported outcomes (PROs). By incorporating PROs alongside traditional disease activity assessments, this study will provide a comprehensive understanding of how different treatment strategies impact both clinical and patient-centered outcomes. This patient-focused approach has the potential to significantly influence treatment guidelines and improve the overall management of RA flares.
Aim: To compare the effectiveness of IM versus PO GC in improving patient-reported symptoms of RA flares.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatologist verified RA diagnosis.
- •Patients are allowed to be on non-steroidal anti-inflammatory drugs (NSAIDs) prior to randomization, but the dosages must be stable for ≥2 weeks prior to randomization.
- •Patients must be on stable doses of conventional synthetic disease-modifying antirheumatic drugs (csDMARD)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARD)/biologics (bDMARDs) for ≥8 weeks prior to randomization.
排除标准
- •Allergies, intolerances or contraindications to systemic GCs or IM injections
- •Patients with active malignancy, are pregnant or breastfeeding.
- •Patients who have received systemic or intra-articular GC within 4-weeks of randomization.
研究组 & 干预措施
Oral
Oral steroid arm: Prednisone 15 mg/day for a week, reducing by 5 mg/day every 7 days until tapered off
干预措施: Glucocorticoid (GC) (Drug)
Intramuscular
Single dose 120 mg intramuscular methylprednisolone to the deltoid
干预措施: Glucocorticoid (GC) (Drug)
结局指标
主要结局
Rheumatoid Arthritis Flare Questionnaire (RA-FQ)
时间窗: Weeks 0, 1, 2, 4, 6 (primary outcome at 6-weeks)
The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) was created and endorsed in 2016 by OMERACT to assess flare treatment response over time, addressing many of the shortcomings associated with the use of disease activity measure scores to gauge flare evolution. The RA-FQ includes five patient-reported items-pain, physical function, stiffness, fatigue, and participation-rated on an 11-point scale over the past week, producing a total score from 0 to 50, with higher scores indicating worse flare disease activity. Validated for content and construct validity, the RA-FQ is sensitive to change within one week and aligns well with the Clinical Disease Activity Index (CDAI), making it a practical, patient-centered tool with strong clinical relevance.
次要结局
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Weeks 0 and 6)
- Clinical Disease Activity Index (CDAI)(Weeks 0 and 6)
- Glucocorticoid adverse events(6-weeks)
- Systemic GC use between 6 and 12 weeks(6 to 12-weeks)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Weeks 0 and 6)
- Clinical Disease Activity Index (CDAI)(Weeks 0 and 6)
- Glucocorticoid adverse events(6-weeks)
- Systemic GC use between 6 and 12 weeks(6 to 12-weeks)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Weeks 0 and 6)