COLCHICORTColchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
Colchicine opocalcium 1mg
+ Prednisone : Cortancyl 20mg
Artritis+2
+ Artropatías por cristales
+ Condrocalcinosis
Estudio de Tratamiento
Resumen
Fecha de inicio: 5 de febrero de 2018
Fecha en la que se inscribió al primer participante.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. 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 offer an interesting alternative with the potential of being better tolerated. However, even oral steroids are recommended, their efficacy in CPPD arthritis isn't demonstrated. Interesting comparative results with NSAIDs were shown for the treatment of gout flares. These results may not be fully extrapolated to CPPD which holds differences with gout. In addition, oral steroids were not compared to colchicine which is the benchmark treatment in many countries for CPPD. The aim of this study is to compare the efficacy of colchicine and oral steroids for the treatment of CPPD acute arthritis and compare their tolerance profile. It is the first large randomized controlled trial comparing two treatments of CPPD acute arthritis.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 111 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 7 ubicaciones
Lille Catholic Hospital
Lille, FranceCH Valenciennes
Valenciennes, FranceDr Nicolas SEGAUD
Armentières, France