Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 14
- 主要终点
- Change from baseline in the pain VAS at 24 hours
研究概览
简要总结
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment.
Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population.
Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied.
From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis.
This is the first large randomized controlled trial for CPPD acute arthritis.
详细描述
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
Some factors are known to trigger CPPD arthritis (trauma, surgery, infection, hospitalization). Prevalence increases with age, and case series estimate the presence of chondrocalcinosis in over 20% of 80 plus years population.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease (this one related to monosodium urate crystals that deposit after long-standing hyperuricemia.
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
盲法说明
No masking is used. All involved know the identity of the intervention assignment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 65 and older
- •Patient with mono/polyarticular CPPD acute arthritis
- •Hospitalized patient (without infectious syndrome considered insufficiently controlled by the clinicians and diabetic decompensation)
- •Diagnosis confirmed :
- •By the evidence of CPP crystals on synovial fluid examination.
- •By the existence of a typical clinical arthritis (joint pain, erythema, swelling, maximal intensity in less than 24h) AND presence of chondrocalcinosis signs in knee, wrists, or pubic symphysis on plain X-rays or crowned tooth in cervical rachis scan.
- •Pain VAS ≥ 40/100 at the enrollment
- •Duration of symptoms evolution for less than 36h.
- •No prior intake of oral steroids, colchicine or NSAIDs for this acute arthritis.
- •Signed patient's consent.
- •Affiliation to a social security scheme.
排除标准
- •Contraindication to colchicine (creatinine clearance below 30ml/min, severe hepatic dysfunction, macrolide or ongoing pristinamycin or macrolid treatment, …) or corticoids utilization (uncontrolled diabetes, uncontrolled progressive infection, uncontrolled arterial hypertension…)
- •Severe cognitive disorders that does not allow patient to evaluate his pain.
- •Patient under guardianship, curatorship
- •Patient receiving morphinic analgesia.
- •Gout history or presence of monosodium urate crystals at the examination of the synovial fluid.
研究组 & 干预措施
Prednisone (corticoids)
Patients assigned to this group will receive Prednisone : Cortancyl 20mg.
干预措施: Prednisone : Cortancyl 20mg (Drug)
Colchicine
Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment.
干预措施: Colchicine opocalcium 1mg (Drug)
结局指标
主要结局
Change from baseline in the pain VAS at 24 hours
时间窗: From the first treatment administration to 24 hours after.
Evolution of the pain Visual Analog Scale (VAS), between baseline and 24 hours after the first treatment administration, without any recourse to other anti-inflammatory treatments.
次要结局
- Proportion of patients with at least one adverse event within 48 hours(48 hours following the first administration)
- Change from baseline of biological inflammatory syndrome at 48 hours(From the first treatment administration to 48 hours after.)
- Number of joints affected and their localizations(Before, 24 hours and 48 hours after the first administration)
- Need of emergency morphinic treatment(24 hours after the first administration)
- Analgesic consumption(From 24 hours to 48 hours after the first treatment administration)
- Proportion of patients with an efficacy response of at least 50%(24 hours and 48 hours after the first administration.)
- Proportion of patients with an efficacy response of at least 20%(8, 12 and 24 hours after the first administration.)
- Complete crisis resolution within 7 days(7 days after 1st administration)
- Initial crisis resolution delay(7 days after 1st administration)
- Absence of crisis recidivism within 7 days(Within the 7 days following the 1st administration)