NCT04579848进行中（未招募）4 期
The Methotrexate in ERosive INflammatory Osteoarthritis (MERINO) Trial: A Randomized Placebo-controlled Trial to Investigate Clinical Efficacy and Safety of Methotrexate in Erosive Inflammatory Hand Osteoarthritis.
Diakonhjemmet Hospital1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2021年8月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Finger pain on a visual analogue scale
研究概览
简要总结
A placebo-controlled randomized controlled trial exploring the effect of methotrexate on pain, function and structural outcomes in erosive inflammatory hand osteoarthritis.
详细描述
The trial will include Norwegian adult males and females with symptomatic erosive inflammatory hand osteoarthritis.
Participants will be randomized 1:1 to either:
- Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks (intervention group). Dosage can be reduced to as low as 10 mg if higher doses are not tolerated.
- Placebo (control group).
Both arms will receive folic acid 1mg daily.
The treatment duration for both groups is 52 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical placebo cannot be produced due to text, color and shape of methotrexate tablets. Thus, both placebo and methotrexate will be encapsulated to ensure blinding.
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
- •Finger joint pain 40-80 on 0-100 visual analog scale (VAS) with insufficient pain relief from, inability to tolerate or contra-indications to oral paracetamol and/or NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6 weeks before randomization.
- •Hand OA according to the American College of Rheumatology (ACR) criteria, at least 1 distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on ultrasound.
排除标准
- •A full list of the exclusion criteria for this study comprised the following:
- •Contraindications to methotrexate:
- •Abnormal renal function, defined as serum creatinine >142 µmol/L in women and >168 µmol/L in men, or a glomeruli filtration rate (GFR) <40 mL/min/1.73 m
- •Abnormal liver function, defined as transaminases above the upper normal limit, active or previous hepatitis B or C infection, or known cirrhosis
- •Lung fibrosis (maximum 6 months old x-ray), active infection, or reduced hematopoiesis (i.e. anemia, leukopenia and/or thrombocytopenia).
- •Planned pregnancy within 18 months after screening (men/women), and pregnancy, breastfeeding, or insufficient anti-conception therapy for female fertile participants. Contraception should be maintained during treatment and until the end of systemic exposure, i.e. 3 months after methotrexate discontinuation. Sufficient anti-conception therapy consists of intra-uterine device (coil) or hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections).
- •Alcohol or other drug abuse in the last year.
- •Intolerance to lactose.
- •Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor or anti-CCP antibodies.
- •Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood dyscrasias, and coagulation disorders, history of malignancy (except successfully treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary disease, severe and/or opportunistic infections and/or chronic infections, active tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone marrow hypoplasia, or demyelinating diseases of the central nervous system.
- •Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, injury in finger joints previous 6 months, or palmar tenosynovitis/trigger finger.
- •Oral or intra-muscular steroids in the previous month
- •Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
- •Analgesics or NSAIDs, unless stable dosage for ≥1 month.
- •Symptomatic slow-acting drugs for OA (SYSADOA), unless stable dose for ≥3 months and require stable dose throughout the study.
- •Disease-modifying osteoarthritis drugs (DMOADs) previous three months.
- •Scheduled hand surgery during study participation.
- •Planning to start other treatments for hand OA in the study participation period.
- •Not able to adhere to the study visit schedule and protocol requirements.
研究组 & 干预措施
Methotrexate
Active Comparator
Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks.
Additional Folic acid 1mg prescribed daily.
干预措施: Methotrexate Tablets (Drug)
Methotrexate
Active Comparator
Methotrexate oral x 1/week; weekly starting dose 15 mg for two weeks, followed by 20 mg the remaining weeks.
Additional Folic acid 1mg prescribed daily.
干预措施: Folic Acid 1 MG (Drug)
Placebo
Placebo Comparator
3 capsules per week for two weeks, followed by 4 capsules the remaining weeks.
Additional Folic acid 1mg prescribed daily.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
3 capsules per week for two weeks, followed by 4 capsules the remaining weeks.
Additional Folic acid 1mg prescribed daily.
干预措施: Folic Acid 1 MG (Drug)
结局指标
主要结局
Finger pain on a visual analogue scale
时间窗: 6 months
Difference in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 6 months of treatment; higher value indicate worse outcome.
次要结局
- Finger pain on a visual analogue scale(Month 1, 3, 9 and 12.)
- Thumb pain on a visual analogue scale(Month 1, 3, 6, 9 and 12.)
- Pain most painful finger joint on a visual analogue scale(Month 1, 3, 6, 9 and 12.)
- Patient-reported disease activity on a visual analogue scale(Month 1, 3, 6, 9 and 12.)
- Pain all joints on a visual analogue scale(Month 1, 3, 6, 9 and 12.)
- Hand diagram pain(Month 6.)
- Body diagram pain(Month 6.)
- AUSCAN(Month 1, 3, 6, 9 and 12.)
- OMERACT-OARSI responder criteria(Month 1, 3, 6, 9 and 12.)
- EQ-5D(Month 1, 3, 6, 9 and 12.)
- MHOQ(Month 6.)
- Grip strength(Month 1, 3, 6, 9 and 12.)
- HOOS-12(Month 6.)
- KOOS-12(Month 6.)
- Concomitant medication(Month 1, 3, 6, 9 and 12.)
- Tender and swollen joints(Month 1, 3, 6, 9 and 12.)
- Physician-reported disease activity on a visual analogue scale(Month 1, 3, 6, 9 and 12.)
- Hand radiographs: Kellgren Lawrence(Month 6 and 12)
- Hand radiographs: Verbruggen-Veys anatomical phase scoring system(Month 6 and 12)
- Hand radiographs: OARSI atlas(Month 6 and 12)
- Hand MRI(Month 6)
- Hand ultrasound(Month 1, 3, 6, 9 and 12.)
- Knee ultrasound(Month 6)
- Hip ultrasound(Month 6)
- Adverse events(Through study completion, maximum 12 months, in addition to 3 months after end of treatment.)
研究者
Ida Kristin Haugen
Senior researcher, doctor
Diakonhjemmet Hospital
研究点 (1)
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