E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammation in periarticular structures in patients refractory to NSAIDs and / or corticosteroids. |
Problemas de inflamación localizados en estructuras periarticulares en pacientes refractarios a AINEs y/o corticoides. |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammation in periarticular structures in patients refractory to NSAIDs and / or corticosteroids. |
Problemas de inflamación localizados en estructuras periarticulares en pacientes refractarios a AINEs y/o corticoides. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
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 evaluate the efficacy of anakinra in the treatment of periarticular inflammation in patients refractory to NSAID and / or steroids. |
Evaluar la eficacia de Anakinra en el tratamiento de la inflamación periarticular en pacientes refractarios a AINEs y/o corticoides. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the safety of Anakinra: recording of adverse events and monitoring of biochemical analysis. - Determine the number of injections per patient. - Determine the number of patients who need more than one injection of Anakinra. - Determine the number of patients who needed rescue medication. - To determine the dose of rescue medication per patient. - Evaluate the action of anakinra in inflammation by an imaging test (ultrasound). |
- Evaluar la seguridad de Anakinra: registro de los acontecimientos adversos y seguimiento de análisis bioquímicos. - Determinar el número de inyecciones por paciente. - Determinar el número de pacientes que necesitarán más de una inyección de Anakinra. - Determinar el número de pacientes que necesitarán medicación de rescate. - Determinar la dosis de medicación de rescate por paciente. - Evaluar la acción de anakinra en inflamación mediante una prueba de imagen (ecografía). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female patients over 18 years of age at the time of the screening visit. - Supraspinatus tendonitis, plantar fasciitis, trochanteric bursitis and / or lateral epicondylitis patients refractory to NSAIDs and / or corticosteroids, lack or loss of efficacy or contraindications. - Patients with a score on the VAS pain score greater than or equal to 6 cm - Patients able to understand the implications of the study and demonstrate it through voluntary signing of informed consent. |
- Pacientes hombres y mujeres mayores de 18 años de edad en el momento de la visita de selección. - Los pacientes refractarios a AINEs y/o corticoides, por falta o pérdida de eficacia o porque los tengan contraindicados, con tendinitis del supraespinoso, fascitis plantar, bursitis trocantérea y/o epicondilitis lateral. - Pacientes que tengan una puntuación en la escala EVA de dolor igual o mayor a 6 cm - Pacientes capaces de comprender las implicaciones del estudio y que así lo demuestren mediante su firma voluntaria del consentimiento informado. |
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E.4 | Principal exclusion criteria |
- Pregnancy or breast-feeding - Participation in any clinical investigation within 3 months prior to drug administration. - Elective surgery patients during the trial. - History of drug or alcohol abuse during the 12 months prior to drug administration. |
- Mujeres embarazadas o en periodo de lactancia. - Participación en alguna investigación clínica dentro de los 3 meses anteriores a la administración del fármaco. - Pacientes con cirugía programada durante el ensayo. -Historia de abuso de drogas o alcohol durante los 12 meses previos a la administración del fármaco. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Evaluation of the patient's pain by VAS (0-10) |
- Evaluación del dolor mediante EVA (0-10) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Basal, + 7 , +15, +30 and +60 days |
Basal, + 7 , +15, +30 and +60 días |
|
E.5.2 | Secondary end point(s) |
- Adverse Events. - Number of injections per patient. - Number of patients needed more than one injection. - Number of patients need to take paracetamol for pain in the affected area. - Total dose paracetamol in patients who have needed to alleviate pain in the affected area. - Ultrasound results |
- Acontecimientos adversos - Número de inyecciones por paciente. - Número de pacientes con necesidad de más de una inyección. - Número de pacientes con necesidad de tomar paracetamol para paliar el dolor en la zona afectada. - Dosis de paracetamol total en los pacientes que la han necesitado para paliar el dolor en la zona afectada. - Resultados de Ecografía. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Basal, + 7 , +15, +30 and +60 days |
Basal, + 7 , +15, +30 and +60 días |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned days | |