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    Summary
    EudraCT Number:2013-002611-96
    Sponsor's Protocol Code Number:ANAK/IL-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-002611-96
    A.3Full title of the trial
    Pilot study to determine the efficacy of anakinra (antagonist of interleukin-1 receptor) administered for 3 months in improving inflammatory signs observed by MRI in patients with erosive/inflammatory hand osteoarthritis.
    Estudio piloto sobre la eficacia de anakinra (antagonista del receptor de interleuquina-1) administrado durante 3 meses para mejorar los signos inflamatorios observados por RMN en pacientes con artrosis erosiva / inflamatoria de manos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate anakinra efficacy in patients with hand's osteoarthritis.
    Estudio para la eficacia del medicamento anakinra en pacientes con artrosis de manos.
    A.4.1Sponsor's protocol code numberANAK/IL-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar
    B.5.2Functional name of contact pointServicio de Reumatología
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim, 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932483345
    B.5.5Fax number0034932483259
    B.5.6E-mailjmonfort@parcdesalutmar.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with erosive/inflammatory hand osteoarthritis.
    Pacientes con artrosis erosiva / inflamatoria de manos.
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis
    Artrosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the changes observed by MRI on radiologic signs of osteoarticular inflammation (synovitis, bone edema, tenosynovitis and bone erosions).
    Evaluar los cambios observados por RMN en los signos radiológicos de inflamación osteoarticular (sinovitis, edema óseo, tenosinovitis y erosiones óseas).
    E.2.2Secondary objectives of the trial
    To evaluate changes in pain, hand functionality and quality of life scale scores.
    Evaluar cambios en la puntuación de las escalas de dolor, función de manos y calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients over 18 years at the moment of the selection visit.
    -Patients with erosive osteoarthritis of the interphalangeal joints with significant clinical activity acording to Anandarajah criteria.
    - Important functional repercussions despite the conventional treatment reflected with a score 24 or more on the AUSCAN questionaire.
    - Patients who can understand the study implications thus they are able to give the written informed consent.
    -Pacientes mayores de 18 años de edad en el momento de la visita de selección.
    -Pacientes con artrosis erosiva de articulaciones interfalángicas con importante actividad clínica según criterios Anandarajah.
    -Importante repercusión funcional a pesar de tratamiento convencional, reflejado en la obtención de una puntuación superior o igual a 24 en el AUSCAN.
    -Pacientes capaces de comprender las implicaciones del estudio y que así lo demuestren mediante su firma voluntaria del consentimiento informado.
    E.4Principal exclusion criteria
    Related to the study
    -Pregnant or breast-feeding.
    -Women of childbearing potential and sexually active not compliant with adequate contraceptive measures during the study.
    -Participation in any clinical investigation within 3 months prior to drug administration
    -Patients with scheduled surgery during the study.
    -History of drug abuse.
    -Patients with any restrictions related to the NMR test

    Related to the medical history:
    -History of malignancy within the last five years.
    -Fibromyalgia and / or chronic fatigue syndrome.
    -Uncontroled cardiovascular disease.
    -Clinical history of inflammatory or systemic diseases.
    -Secondary osteoarthritis such as chondrocalcinosis, Paget's disease, aseptic osteonecrosis, gout, ochronosis, acromegaly, hemochromatosis, Wilson's disease and osteochondromatosis
    -More intense pain in other part of the body that could interfere with the evaluation.
    -Poorly controlled diabetes mellitus, defined by a hemoglobin A1c>8%(25).
    -History of immunosuppression.
    -Acute or chronic infections requiring antibiotic treatment or serious fungal or viral infections (eg hepatitis, herpes zoster, HIV)
    -Major defects of clotting.
    -Active gastrointestinal disease.
    -Acute or chronic liver disease
    -Acute or chronic kidney disease with levels of blood urea nitrogen (BUN) or serum creatinine 2 times ULN or CrCl <30 ml / min at the screening visit.
    -History of significant medical conditions, which in the opinion of the investigator would preclude the patient from participating in this trial
    Related to the treatments:
    -Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYSADOA 12 weeks prior to inclusion.
    -Patients who have used intra-articular hyaluronic acid (in the hand of study) during the 24 weeks prior to the enrollment visit.
    -Patients undergoing radioactive synoviorthesis (in the hand of study)
    -Patients who have received any live virus vaccine within 12 weeks prior to starting the study (also not be allowed during the trial, including the 3 months following the last dose of study medication)
    -Patients treated with other bDMARDs (Biological Disease Modifying Anti-Rheumatic Drugs)
    -Patients treated with oral anticoagulants.
    -Patients with known hypersensitivity to any component of the study drugs.
    -Patients who have experienced asthma, urticaria or allergic reactions after administration of acetylsalicylic acid or NSAIDs.
    Relacionados con el estudio
    -Mujeres embarazadas o en periodo de lactancia.
    -Mujeres en edad fértil y con vida sexual activa que no acepten tomar medidas anticonceptivas aceptables.
    -Participación en alguna investigación clínica durante los tres meses previos a la administración del fármaco
    -Pacientes con cirugía programada durante el ensayo.
    -Historia de abuso de drogas.
    -Pacientes con contraindicaciones para la RMN
    Relacionados con el historial médico:
    -Historia de neoplasia maligna en los últimos 5 años.
    -Fibromialgia y/o síndrome de fatiga crónica.
    -Enfermedad cardiovascular mal controlada.
    -Historia clínica de enfermedades inflamatorias o sistémicas.
    -Artrosis secundarias como condrocalcinosis, enfermedad de Paget, osteonecrosis aséptica, gota, ocronosis, acromegalia, hemocromatosis, enfermedad de Wilson o osteocondromatosis
    -Dolor más intenso en otra parte del cuerpo que pueda interferir con la evaluación.
    -Diabetes Mellitus mal controlada, definida por una hemoglobina A1c>8%(25).
    -Historia de inmunodepresión.
    -Infección aguda y/o crónica que requiera el tratamiento antimicrobiano o infecciones fúngicas o virales graves (por ejemplo hepatitis, herpes zoster, positivo para el VIH)
    -Defecto importante de coagulación.
    -Enfermedad gastrointestinal activa.
    -Hepatopatía crónica y/o aguda
    -Pacientes con nefropatía crónica con unos niveles de nitrógeno ureico en sangre (BUN) o de creatinina sérica 2 veces el LSN o Clcr<30 ml/minuto en la visita de selección.
    -Historia de condiciones médicas significativas, que en opinión del investigador excluirían al paciente de participar en este ensayo.
    Relacionadados con los tratamientos:
    -Pacientes que tomen corticoesteroides (orales o inyectables), metotrexato, hidroxicloroquina o SYDADOA las 12 semanas previas a la inclusión.
    -Pacientes que hayan utilizado ácido hialurónico intrarticular (en la mano de estudio) durante las 24 semanas previas a la visita de inclusión.
    -Pacientes sometidos a sinoviortesis radioactiva (en la mano de estudio)
    -Pacientes que hayan recibido alguna vacunación de virus vivos durante las 12 semanas previas al comienzo del ensayo (tampoco estarán permitidas durante el ensayo, incluidos los 3 meses posteriores a la última dosis de medicación de estudio).
    -Pacientes en tratamiento con otros fármacos biológicos antireumáticos modificadores de la enfermedad.
    -Pacientes en tratamiento con anticoagulantes orales.
    -Pacientes con hipersensibilidad a alguno de los componentes de los fármacos
    -Pacientes que hayan presentado asma, urticaria o cualquier tipo de reacción alérgica después de la administración de ácido acetilsalicílico o AINE.
    E.5 End points
    E.5.1Primary end point(s)
    The evaluation of changes observed on MRI radiologic signs of osteoarticular's disease. The two MRI performed will include imaging in axial, coronal and sagittal sections of the proximal and distal interphalangeal joints of the dominant hand with T1, T1 Fat-Sat with gadolinium and T2 FAT-SAT.
    Images will be scored according to the standard method of evaluation of erosive hand osteoarthritis by MRI. This assessment includes scoring of:
    - Synovitis: 0-3
    - Tenosynovitis of the flexor tendons: 0-3
    - Bone edema: 0-3, proximal/distal
    -Ligamentous involvement injury: presence/absence of discontinuity; distal/proxima side.
    - Osteopyhtes (structual changes): 0-3; distal/proximal
    - Subchondral cysts (structural changes): presence/absence; distal/proximal.
    - Joint space narrowing (structural changes): 0-3
    - Bone erosion: 0-3 distal/proximal
    The scans will be reported by two expert radiologists experienced in musculoskeletal MRI, blinded to all clinical data.
    La evaluación de los cambios de la actividad de la enfermedad mediante RMN por parte del radiólogo evaluador. Se realizarán dos RMN que incluirán planos axiales, coronales y sagitales de las cuatro articulaciones IFps e IFds de la mano de estudio mediante las secuencias T1, T1 FAT-SAT con gadolinio y T2 FAT-SAT.
    Se evalúan la presencia y severidad de las alteraciones relacionadas con la afectación estructural y la actividad inflamatoria en artrosis de manos, así como los eventuales cambios en dichas alteraciones tras el tratamiento.
    Los mencionados cambios se evaluarán en acuerdo con la metodología propuesta como standard para la evaluación de la artrosis erosiva de manos mediante RMN.
    Se obtendrán puntuaciones para los siguientes signos
    - Sinovitis: Grado 0-3
    - Tenosinovitis tendones flexores: Grado 0-3
    - Edema óseo: grado 0-3; proximal/distal
    - Lesión en la inserción de ligamentos colaterales de las articulaciones interfalángicas: ausencia/presencia de discountinuidad; lado cubital/radial.
    - Osteofitos (lesión estructural): grados 0-3; distal/proximal.
    - Quistes subcondrales (lesión estructural): presencia/ausencia; distal/proximal.
    - Disminución espacio articular (lesión estructural): grados 0-3.
    - Erosión ósea: grados 0-3; distal/proximal.

    Dos radiólogos expertos en RMN articular y ciegos a los datos clínicos se encargarán de la lectura de las imágenes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The MRI will be performed at visits 0 and 4.
    Las RMN se realizarán en las visitas 0 y 4.
    E.5.2Secondary end point(s)
    Changes on scores of pain, quality of life and function on osteoarthritis questionnaires:
    -VAS scale
    -Quality of LifeQuestionnaire EuroQol-5d
    -AUSCAN hand function scale.
    Hand strength measured by a cuff (previously inflated to 60 mmHg).
    Security index evaluated by urine and blood analysis.
    Analytical changes in inflammatory parameters.
    Cambios de los valores de cuestionarios relacionados con el dolor, la función y la calidad de vida en los pacientes con artrosis erosiva de manos:
    - Escalas EVA
    - EuroQol-5d
    - AUSCAN
    Cambios en la fuerza de prensión (mediante un manguito inflado a 6o mmHg).
    Seguridad a lo largo del ensayo valorada mediante la obtención de muestras de sangre y orina.
    Cambios analíticos en los parámetros inflamatorios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - VAS and AUSCAN scales will be performed in all visits.
    - EuroQol-5d will be performed at visits 0, 2, 4 and 6
    - Urine and blood analysis at visits -1, 1, 2, 3, 4 and 6
    - Pression force at visits 0, 1, 2, 3, 4, 5 and 6.
    - Las escalas EVA y AUSCAN se realizarán en todas las visitas.
    - El EuroQol-5d en las visitas 0, 2, 4 y 6
    - Los análisis de sangre y orina en las visitas -1, 1, 2, 3, 4 y 6
    - La fuerza de prensión en las visitas 0, 1, 2, 3, 4, 5 y 6.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    The end of the trail is defined as the last test of the last patient recruited.
    Se considerará final del ensayo la fecha de la última visita del último sujeto reclutado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be sent to their usual doctor to receive the appropriate treatment.
    Los pacientes serán remitidos a su médico habitual recibiendo el tratamiento que se considere oportuno.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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