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    Summary
    EudraCT Number:2013-003467-60
    Sponsor's Protocol Code Number:M13-741
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-22
    Trial results View 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 number2013-003467-60
    A.3Full title of the trial
    A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis
    Estudio de fase 2a para evaluar la seguridad, la eficacia y los efectos farmacodinámicos de ABT 981 en pacientes con osteoartritis de rodilla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis
    Estudio de fase 2a para evaluar la seguridad, la eficacia y los efectos farmacodinámicos de ABT 981 en pacientes con osteoartritis de rodilla
    A.4.1Sponsor's protocol code numberM13-741
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbvie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott house, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0034901 20 01 03
    B.5.5Fax number+441628644330
    B.5.6E-mailabbvie_reec@abbvie.com
    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 No
    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 nameABT-981
    D.3.2Product code ABT-981
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNna
    D.3.9.3Other descriptive nameABT-981
    D.3.9.4EV Substance CodeSUB127307
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboLyophilisate for suspension for injection
    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
    Adult male and female patients with mild to moderate, symptomatic, radiographic and inflammatory osteoarthritis of the knee
    Pacientes adultos de ambos sexos con osteoartritis de rodilla sintomática, radiográfica e inflamatoria leve o moderada.
    E.1.1.1Medical condition in easily understood language
    Mild to moderate knee osteoarthritis
    Osteoartritis de rodilla leve o moderada
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-quantitative MRI scoring at Week 26 in patients with knee osteoarthritis.
    Valorar el efecto de ABT 981 en el dolor de rodilla por osteoartritis (OA) mediante el índice de osteoartritis de Western Ontario and McMaster Universities (WOMAC) en la semana 16 y la sinovitis/volumen de derrame de la rodilla de referencia mediante medidas cuantitativas y la puntuación semicuantitativa en la RM en la semana 26 en pacientes con osteoartritis de rodilla.
    E.2.2Secondary objectives of the trial
    n/a
    na
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. PK substudy
    2. Synovial Fluid substudy
    3. DCE-MRI substudy
    1. Subestudio farmacocinético (FC)
    2. Subestudio de liquid sinovial
    3. Subestudio de Resonancia Magnética con Contraste Dinámico (RM-cd)
    E.3Principal inclusion criteria
    1.Patient must have radiographic evidence of knee osteoarthritis in the medial compartment of the index knee with Kellgren-Lawrence Grade 2 or 3 (with minimum 2 mm joint space width) during Screening as evaluated by a qualified central imaging reader. Prior radiographs taken no more than 3 months before Study Day 1 with Synaflexer? will be submitted for centralized eligibility reading.
    2. Patient must have either constant or intermittent index knee pain at least 14 days over the past 30 days at screening. The intensity of index knee pain is between 4 and 8 out of 10, inclusive, at the initial Screening Visit and Study Day 1. The intensity of index knee pain is recorded as the average pain during the past week.
    3.Patient has one or more clinical signs and symptoms of active inflammation in the index knee (localized pain, joint stiffness, swelling and effusion) during Screening and Study Day 1.
    4.Presence of synovitis in the index knee confirmed by ultrasound during Screening.
    5.Patient discontinued analgesics, non-steroidal anti-inflammatory drugs and nutraceuticals (e.g., glucosamine, chondroitin sulfate, shark cartilage, diacerein, soy extract) at least 7 days prior to first dose of study drug until after Week 26 MRI visit.
    1. El paciente deberá tener signos radiológicos de osteoartritis de rodilla en el compartimiento medial interno de la rodilla de referencia con un grado 2 ó 3 de Kellgren Lawrence (con una anchura mínima del espacio articular de 2 mm) durante la selección evaluado por un intérprete central de imágenes cualificado. Se remitirán para interpretación centralizada de la elegibilidad radiografías previas obtenidas no más de 3 meses antes del día 1 con Synaflexer?.
    2. El paciente deberá haber presentado dolor constante o intermitente en la rodilla de referencia durante como mínimo 14 días de los 30 días precedentes en la selección. La intensidad del dolor de la rodilla de referencia debe estar comprendida entre 4 y 8 sobre 10, ambos inclusive, en la visita de selección inicial y el día 1 del estudio. La intensidad del dolor de la rodilla de referencia que se registre será el promedio de dolor durante la semana precedente.
    3. El paciente tiene uno o más síntomas y signos clínicos de inflamación activa en la rodilla de referencia (dolor localizado, rigidez, hinchazón y derrame articulares) durante la selección y en el día 1 del estudio.
    4. Presencia de sinovitis en la rodilla de referencia confirmada por ecografía durante la selección.
    5. El paciente interrumpió los analgésicos, los antiinflamatorios no esteroideos y los nutracéuticos (p. ej., glucosamina, condroitin sulfato, cartílago de tiburón, diacereina, extracto de soja) desde al menos 7 días antes de la primera dosis del fármaco del estudio hasta después de la visita de RM de la semana 26.
    E.4Principal exclusion criteria
    1.History of allergic reaction or significant sensitivity to any constituents of the study drug, history of anaphylactic reaction to any agent (e.g., food products or bee stings) or history of a major reaction to any IgG-containing product.
    2.Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 6 months of Screening.
    3.Kellgren-Lawrence Grade 1 or 4 in the index knee.
    4.Severe knee malalignment, either greater than 2° in varus; or greater than 5° in valgus angulation in the index knee.
    5.Diagnosis of one or more of the following:
    a.Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthropathy, gout, or pseudogout (defined as acute episodic attacks of swollen , painful joints in a patient with X-Ray chondrocalcinosis or CPPD crystals);
    b.Other chronic painful syndromes (such as Paget's disease and fibromyalgia) and clinically significant non-articular musculoskeletal pain that could interfere with assessment of pain at the index knee.
    6. History or evidence of active tuberculosis (TB)
    7. Any uncontrolled medical illness or unstable treatment ot therapy.
    1. Antecedentes de reacción alérgica o sensibilidad importante a cualquier componente del fármaco del estudio, de reacción anafiláctica a cualquier producto (p. ej., alimentos o picaduras de abeja) o de una reacción importante a cualquier producto que contenga IgG.
    2. Traumatismo o cirugía importantes en la rodilla de referencia en el último año o artroscopia de la rodilla de referencia en los 6 meses previos a la selección.
    3. Grado 1 ó 4 de Kellgren Lawrence en la rodilla de referencia.
    4. Desalineación grave de la rodilla, ya sea angulación superior a 2° en varo o angulación superior a 5° en valgo en la rodilla de referencia.
    5. Diagnóstico de uno o más de los siguientes:
    ? Artritis inflamatoria como artritis reumatoide, trastorno autoinmunitario, espondiloartropatía seronegativa, gota o seudogota (definida como crisis episódicas agudas de hinchazón y dolor articulares en un paciente con condrocalcinosis radiográfica o cristales CPPD);
    ? Otros síndromes dolorosos crónicos (como enfermedad de Paget y fibromialgia) y dolor músculo-esquelético no articular de importancia clínica que pueda interferir en la valoración del dolor en la rodilla de referencia.
    6. Antecedentes o pruebas de tuberculosis activa (TB).
    7. Cualquier enfermedad médica no controlada o un tratamiento o terapia inestable.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to week 16 in OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and from baseline to week 26 in synovitis/effusion volume of the index knee using quantitative and semi-quantitative MRI scoring
    Cambios de la puntuación WOMAC del dolor de la rodilla de referencia desde el momento basal a la semana 16 y cambios de la sinovitis/volumen de derrame en la RM de la rodilla de referencia desde el momento basal a la semana 26 usando medidas cuantitativas y semicuantitativas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 and Week 26
    Semana 16 y Semana 26
    E.5.2Secondary end point(s)
    ? To evaluate the safety and tolerability of ABT-981 in patients with knee OA.
    ? To evaluate the effect of ABT-981 on physical function scores of the index knee at Weeks 16, 26 and 52 using WOMAC.
    ? To evaluate the effect of ABT-981 on index knee pain scores at Weeks 26 and 52 using WOMAC.
    ? To evaluate the effect of ABT-981 in reduction of bone marrow lesions (BML) of the index knee MRI at Weeks 26 and 52 using semi quantitative measurements (WORMS).
    ? To evaluate the effect of ABT-981 on index knee resting pain at Weeks 16, 26 and 52 using the Intermittent and Constant Osteoarthritis Pain (ICOAP) score.
    ? To evaluate the effect of ABT-981 on index knee resting pain at Weeks 16, 26 and 52 using the 11-point NRS scale (NRS-11).
    ? To evaluate the effect of ABT-981 on Patient Global Assessment of Arthritis at Weeks 16, 26 and 52.
    ? To evaluate the effect of ABT-981 on the preservation of cartilage volume/thickness of the index knee using MRI at Weeks 26 and 52.
    ? Evaluar la seguridad y la tolerabilidad de ABT 981 en los pacientes con OA.
    ? Evaluar el efecto de ABT 981 en las puntuaciones de la función física de la rodilla de referencia en las semanas 16, 26 y 52 mediante WOMAC.
    ? Evaluar el efecto de ABT 981 en las puntuaciones de dolor de la rodilla de referencia en las semanas 26 y 52 mediante WOMAC.
    ? Evaluar el efecto de ABT 981 para reducir las lesiones de médula ósea (LMO) en la RM de la rodilla de referencia en las semanas 26 y 52 empleando medidas semicuantitativas (WORMS).
    ?Evaluar el efecto de ABT-981 en el dolor en la rodilla de referencia en las semanas 16, 26 y 52 mediante la puntuación del dolor de la osteoartritis intermitente y constante (ICOAP).
    ?Evaluar el efecto de ABT 981 en el dolor de la rodilla de referencia en las semanas 16, 26 y 52 utilizando la escala NRS de 11 puntos (NRS-11).
    ? Evaluar el efecto de ABT 981 en la Valoración Global del Paciente (VGP) de la artritis en las semanas 16, 26 y 52.
    ? Evaluar el efecto of ABT 981 en la conservación del volumen/grosor del cartílago de la rodilla de referencia mediante una RM en las semanas 26 y 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 16, 26 and 52
    Semana 16, 26 y 52
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Denmark
    France
    Germany
    Italy
    Mexico
    Netherlands
    Spain
    United Kingdom
    United States
    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
    Last subject last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 320
    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)
    Returm to standard of care
    Volver a la medicación habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-13
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