E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. |
Artritis Reumatoide y alta actividad clínica que además presenten periodontitis crónica moderada-avanzada |
|
E.1.1.1 | Medical condition in easily understood language |
Active rheumatoid arthritis and periodontitis |
Artritis reumatoide activa y periodontitis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study if the intensive treatment in periodontitis could improve DAS-28(PCR), DAS-28(VSG) y SDAI, clear biomarkers in the active disease in rhematoid arthritis |
Estudiar si el tratamiento intensivo de la periodontitis mejora los parámetros de DAS-28(PCR), DAS-28(VSG) y SDAI, claros marcadores de la actividad de enfermedad, en pacientes con alta actividad clínica de AR. |
|
E.2.2 | Secondary objectives of the trial |
1. to Investigate if the intensive treatment of periodontitis could improve the immunological markers of disease, in patients with high clinical activity of RA. 2. To observe if there is a correlation between low detection of Porphyromonas gingivalis and Agreggatibacter actinomycetemcomitans, and citrullinated anti-peptide antibody titers (ACPA) in patients with high clinical activity of RA. 3. To analyze other possible demographic, environmental, educational and pharmacological factors that could influence the periodontal treatment and its impact in patients with high clinical activity of RA. |
1. Investigar si el tratamiento intensivo de la periodontitis mejora los marcadores inmunológicos de enfermedad, en pacientes con alta actividad clínica de AR. 2. Observar si existe una correlación entre reducción en la detección de Porphyromonas gingivalis y Agreggatibacter actinomycetemcomitans, y los títulos de anticuerpos antipéptidos citrulinados (ACPA) en pacientes con alta actividad clínica de la AR. 3. Analizar otros posibles factores demográficos, ambientales, educacionales y farmacológicos que pudieran influir en el tratamiento periodontal y su impacto en pacientes con alta actividad clínica de AR. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients more than 18 years with RA (ACR/EULAR 2010 criteria) with high clinical activity defined SG) y/o DAS28 (PCR)> 5,1 y SDAI > 26. Ptients with moderate-severe chronic peridontitis (Level 2 Tonetti 2005) Paients with 8 teeth and more than 8 teeth. |
Pacientes mayores de 18 años que cumplan los criterios diagnósticos de ACR/EULAR 2010 para AR y que presentan alta actividad clínica de la enfermedad definida por DAS 28(VSG) y/o DAS28 (PCR)> 5,1 y SDAI > 26. Pacientes con periodontitis crónica moderada a avanzada (Nivel 2 Tonetti 2005) Presencia 8 o más dientes. |
|
E.4 | Principal exclusion criteria |
Non-surgical periodontal treatment during the previous 6 months Oral surgical treatment during the previous 12 months Antibiotic treatment in the previous 6 months Pre-treatment with cyclosporin-A, calcium channel blockers or phenytoin. Requirement of antibiotic prophylaxis prior to oral examination. Patients with RA who carry any prosthetic joint replacement. Patients who collaborate and who are able to sign informed consent. |
Tratamiento periodontal no quirúrgico durante los 6 meses previos Tratamiento quirúrgico bucodental durante los 12 meses previos Tratamiento con antibiótico en los 6 meses previos Tratamiento previo con ciclosporina-A, bloqueantes de los canales del calcio o con fenitoína. Requerimiento de profilaxis con antibiótico previo al examen oral. Pacientes con AR portadores de cualquier recambio articular protésico. Pacientes que colaboradores y que sean capaces de firmar el consentimiento informado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Disease activity: number of Painful joint (NAD), swollen joints (NAT), visual analog scale (physician and patient) EVA, CRP and ESR to calculate DAS28 (SVG), DAS28 (CRP) and SDAI activity indexes. |
Índice de actividad de la enfermedad: Recuento articulaciones dolorosas (NAD), articulaciones tumefactas (NAT), escala analógica visual (médico y paciente) EVA, PCR y VSG para calcular los índices de actividad DAS28 (VSG), DAS28 (PCR) y SDAI . |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
basal and at 30, 90, 180 and 365 days post treatment. |
basal y a los 30, 90,180 y 365 días post tratamiento. |
|
E.5.2 | Secondary end point(s) |
Rheumatoid factor, ACPA, hemoglobin. P. gingivalis cepa ATCC 33277 y A. actinomycetemcomitans cepa DSM 8324 |
Factor Reumatoide (FR), anticuerpos antipéptidos citrulinados ( ACPA), Hemoglobina(Hb) P. gingivalis cepa ATCC 33277 y A. actinomycetemcomitans cepa DSM 8324 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
basal and at 30, 90, 180 and 365 days post treatment. |
basal y a los 30, 90,180 y 365 días post tratamiento. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
dos sesiones de tartrectomía más 15 ml colutorio (PerioAid, Dentaid, España) 60 segundos |
two sessions of tartrectomy and 15ml PerioAId buccal solution 60 seconds. |
|
E.8.2.4 | Number of treatment arms in the trial | 60 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit in last patient recruited |
última visita al último paciente reclutado |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |