The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis - the IMHOA Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Efficacy of intramuscular methylprednisolone acetate in reducing hand pain between baseline and week 4, compared to placebo measured on a 0-100 mm Visual Analogue Scale
研究概览
简要总结
The goal of this clinical trial is to determine the efficacy and safety of intramuscular methylprednisolone in patients with hand osteoarthritis. The main question it aims to answer is what the difference is in hand pain 4 weeks after the first injection with methylplrednisolone. This main goal will be assessed in the first 16 weeks, the RCT phase. Researchers will compare 120mg methylprednisolone with 40mg methylprednisolone and placebo to see if there is a difference in hand pain after 4 weeks.
Participants will be asked to visit the hospital for:
- injection of the study material
- ultrasound assessment
- physical examination like joint assessments and grip strenght
- examination of blood
- x-ray of the hand
In phase 2, from week 16 to 48, an open label phase focusing on treatment strategy and safety. In this phase all participants may receive intramuscular methylprednisolone on demand at the dosage of 120mg only if they fulfil the following conditions: hand pain > 30mm on a VAS (0-100mm) and a minimum of 16 weeks interval between two consecutive injections. Therefore, a maximum of two injections could be received during this period. Irrespective of that, all participants will be followed-up until week 48 when the end-of-study visit will take place.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with interphalangeal hand OA (according to the EULAR classification criteria 2023) based on patient report (age, morning stiffness) and radiographs of ≤6 months old (osteophytes, JSN (joint space narrowing) and symptom-structure concordance (present if majority (≥50%) of the symptomatic joints demonstrate radiographic findings)).
- •Age ≥ 16 years
- •Have hand pain >40mm on a 100mm visual analogue scale (VAS)
- •Have previously experienced failure of at least one conventional type of pain medication, (self-reported of insufficient effect from topical or oral NSAID, etc. with exclusion of paracetamol)
排除标准
- •Comorbidity
- •Chronic inflammatory (rheumatic) diseases
- •Infectious diseases
- •Known Osteoporosis
- •Known Diabetes
- •Previous diagnosis of fibromyalgia
- •Known myasthenia gravis
- •Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.)
- •Use of other Medication: In order to maximize the generalizability of the study interactions between methylprednisolone and co-medication is only prohibited when the Dutch Medication Surveillance System (Z-index) gives a signal for this interaction.
- •Patients with a contraindication for MP
- •Current Gastric and duodenal ulcers
- •Current infections
- •Liver cirrhosis
- •Pregnant or breastfeeding
- •Known non-response or intolerance for MP
- •Not able to read or write the Dutch language
- •Neurological diagnosis
- •Risk of psychiatric disorder
研究组 & 干预措施
Placebo
Placebo (3ml NaCl 0.9%)
干预措施: Placebo (Drug)
40mg
40mg methylprednisolone acetate (1ml + 2 ml NaCl 0.9%)
干预措施: 40mg methylprednisolone acetate (Drug)
120mg
120mg methylprednisolone acetate (3ml)
干预措施: 120mg methylprednisolone acetate (Drug)
结局指标
主要结局
Efficacy of intramuscular methylprednisolone acetate in reducing hand pain between baseline and week 4, compared to placebo measured on a 0-100 mm Visual Analogue Scale
时间窗: From baseline to week 4
The primary objective of this study is to assess the efficacy of intramuscular methylprednisolone acetate (120mg or 40mg) in reducing hand pain between baseline and week 4, compared to placebo measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome.
次要结局
- Non-inferiority of 40mg compared to 120mg MP of the efficacy of intramuscular methylprednisolone acetate in reducing hand pain assessed by the digital 0-100 mm Visual Analogue Scale(From baseline to week 4)
- Change in hand pain at week 4, and thereafter every 4 weeks(From week 8 to week 48)
- Percentage of participants with a reduction in hand pain larger than the MCID(From baseline to week 4)
- Hand function, change in functional index(From baseline to week 48)
- OMERACT-OARSI responder criteria based on pain measured with Visual Analogue Scale(From baseline to week 48)
- OMERACT-OARSI responder criteria based on Visual Analogue Scale hand function(From baseline to week 48)
- OMERACT-OARSI responder criteria based on patient global assessment measured with Visual Analogue Scale(From baseline to week 48)
- Quality of life, measured with EuroQuol-5D-5L(From baseline to week 48)
- Patient experience of steroid use with the Steroid PRO(From baseline to week 48)
- Changes in local inflammation of hand joints, determined with ultrasound(From baseline to week 4)
- Structural changes based on X-ray of the hands(From baseline to week 48)
- Effect on joints based on swollen joint count and tender joint count(From baseline to week 48)
- Changes of systemic inflammation(From baseline to week 48)
- Medication use, health care costs by using the iMTA Productivity Cost Questionnaire(From baseline to week 48)
- Medication use, health care costs by using the iMTA Medical Consumption Questionnaire(From baseline to week 48)
- Explore correlation of baseline values within treatment reponse and develop prediction model(From baseline to week 48)
- Explore subgroups according to structural changes on X-ray of the hand based on erosive or non-erosive, DIP osteophytes or PIP osteophytes, DIP joint space narrowing or PIP joint space narrowing at baseline.(From baseline to week 48)
- Assess safety of methylprednisolone 120mg or 40mg compared to placebo by assessing incidence density and cumulative incidence of AEs and SAEs(From baseline to week 48)
- Evaluate efficacy and safety of methylprednisolone on endpoints mentioned under 2 and 3, comparing participants based on the cumlative dose of MP(From baseline to week 48)
- Explore subgroup differences categorized by demographic factors(From baseline to week 48)
- Explore subgroup differences categorized by X-ray(From baseline to week 48)
- Explore subgroup differences categorized by ultrasound(From baseline to week 4)
- Explore subgroup differences categorized by biomarkers in blood(From baseline to week 48)
- Identification of circulating biomarkers associated with response to MP(From baseline to week 48)