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    Summary
    EudraCT Number:2015-000636-15
    Sponsor's Protocol Code Number:12/201/02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000636-15
    A.3Full title of the trial
    A randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.
    A.3.2Name or abbreviated title of the trial where available
    Subcutaneous Injection of Adalimumab Trial compared with Control
    A.4.1Sponsor's protocol code number12/201/02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN14569274
    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 SponsorBangor University
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBangor University
    B.5.2Functional name of contact pointDr Nefyn Williams
    B.5.3 Address:
    B.5.3.1Street AddressNorth Wales Organisation for randomised Trials in Health, Y Wern, Normal site, Holyhead Road
    B.5.3.2Town/ cityBangor, Gwynedd
    B.5.3.3Post codeLL57 2DG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01248383141
    B.5.6E-mailnefyn.williams@bangor.ac.uk
    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 Humira (Adalimumab)
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAdalimumab (Humira)
    D.3.2Product code EMEA/H/C/000481
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 No
    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
    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
    Sciatica is a symptom defined as unilateral, well-localised leg pain, with a sharp, shooting or burning quality, that approximates to the dermatomal distribution of the sciatic nerve down the posterior lateral aspect of the leg, and normally radiates to the foot or ankle. It is often associated with numbness or paraesthesia in the same distribution
    E.1.1.1Medical condition in easily understood language
    Sciatica is pain caused by irritation or compression of the sciatic nerve root, the nerve runs from the back of your pelvis, through your buttocks, down both legs, ending at your feet
    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 effectiveness of subcutaneous injections of adalimumab plus physiotherapy compared with placebo injection of saline plus physiotherapy for patients with sciatica who have failed first line primary care treatment and
    been referred to an outpatient physiotherapy clinic. The primary effectiveness outcome will be sciatica related health status using the Oswestry Disability Index.
    To evaluate the costeffectiveness of subcutaneous injections of adalimumab plus physiotherapy, compared with placebo injection of saline plus physiotherapy for patients with sciatica who have failed first line primary care treatment
    and been referred to an outpatient physiotherapy clinic, from a health service and personal social care perspective.
    The primary economic outcome will be the incremental cost per Quality Adjusted Life Year (QALY) gained. QALYs will be estimated by administering the EQ5D5L at each followup visit.
    E.2.2Secondary objectives of the trial
    Secondary effectiveness outcomes will include: pain intensity, location, duration, anticipated trajectory and bothersomeness; general health status; the risk of poor outcome; psychological measures including fear avoidance beliefs, self-efficacy, anxiety and depression; employment status; adverse effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years of age and older;
    • Clinical features of sciatica
    • Leg pain worse or as bad as back pain, obtained by asking the participant
    • Unilateral leg pain approximating a dermatomal distribution, (contralateral buttock pain permitted if it does not extend below the inferior gluteal margin) obtained by asking the participant
    • And one of the following:
    o Positive neural tension test such as Straight leg raise test (SLR) restricted <50 degrees by leg pain; positive femoral stretch test, loss of sensation in a dermatomal distribution
    o Muscle weakness or loss of tendon reflex affecting one myotome
    • Persistent symptoms for at least 4 weeks and less than six months
    Persistent symptoms for at least 4 weeks and less than six months despite first line treatment in primary care; obtained by asking the participant
    • Moderate to high severity (≥30) on Oswestry Disability Index.
    • Female partners of sexually active men should use adequate contraceptives for at least five months after the last injection. Female patients should have a negative urine pregnancy test within two weeks prior to randomisation, unless they are postmenopausal or have had a sterilisation operation. Sexually active men must also use adequate contraceptive methods.
    E.4Principal exclusion criteria
    • Symptoms persisting for longer than six months obtained by asking the participant;
    • A previous episode of sciatica in the last six months
    • Unable to perform MRI (e.g. magnetic metal implants, potential metallic intraocular
    foreign bodies, claustrophobia, extreme obesity) obtained from the medical records and by asking the participant
    • Serious spinal pathology, including cauda equina syndrome, malignancy, recent fracture, infection or very large disc prolapse which might require an urgent spinal surgery opinion, identified from participants' previous medical history in their medical records or from magnetic resonance imaging (MRI)
    • Incidental serious pathology identified by MRI (e.g. adrenal tumour)
    • Neurological deficit involving muscle weakness requiring an urgent spinal surgery assessment e.g. foot drop
    • Widespread pain throughout the body including the upper limb (Pain is considered widespread when all of the following are present: pain in the left side of the body, pain in the right side of the body, pain above the waist, and pain below the waist. In addition, axial skeletal pain (cervical spine or anterior chest or thoracic spine or low back) must be present).
    • Prior use of biological agents targeting TNF alpha within the previous six months obtained from the medical records and by asking participant;
    • Previous lumbar spinal surgery obtained from the medical records and by asking the participant;
    • Contraindications to adalimumab injection including serious infection such as active or latent tuberculosis, transplanted organ, demyelinating disorders, malignancy, cardiac failure, low white cell count, pregnancy obtained from the medical records, results of investigations and by asking the participant;
    • Pregnant or breastfeeding (women must not breastfeed for at least five months after the last adalimumab injection.
    • Unable to communicate in English or Welsh; unable or unwilling to give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical outcome will be back pain specific disability using the Oswestry Disability Index measured at 12 months.
    The primary economic outcomes will be the incremental cost per QALY gained, estimated by administering the EQ5D5L at each follow up visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main outcome will be the Oswestry Disability Index for all time points. Participants who need to be referred for disc surgery will be labelled as 'treatment failures' and their last test results prior to surgery will be carried forward in the analysis. The economic analysis will be from the perspective of the NHS and personal social services. Resource use will be measured from routinely collected information, and from patients' self-reporting of resource use, captured by questionnaire. Unit costs for each type of resource will be obtained from standard sources and combined with the resource use information to calculate costs. Quality Adjusted Life Years (QALYs), which are a measure of not only the quantity of life but also its quality, will be calculated from the EQ-5D questionnaire.
    E.5.2Secondary end point(s)
    The secondary outcomes measures are Global assessment of change since baseline, • Anxiety and depression using the Hospital Anxiety and Depression Scale, Employment questions, STarT Back screening tool, Pain trajectory on a single question, • Pain selfefficacy questionnaire and Fear avoidance beliefs using the Tampa Scale of kineKinesiophobia.
    The secondary economic outcome measure is the Resource Use Questionnaire.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 concerned6
    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
    Participants will be followed up for 12 months, 2 weeks after their 12 month questionnaire they will be contacted by telephone for a brief semi-structured interview.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 82
    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 state332
    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)
    If the participants symptoms have settled or are improving, no further intervention will be organised. They will be discharged to the care of their general practitioner and followed up by the research team as described in this protocol.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation North Wales Organisation for Randomised Trials
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-12-31
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