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    Summary
    EudraCT Number:2017-004226-15
    Sponsor's Protocol Code Number:Can-Art1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-01-05
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-004226-15
    A.3Full title of the trial
    CAN-ART

    The efficacy and safety of using cannabis derivatives
    cannabidiol (CBD) and tetrahydrocannabinol (THC)
    for the treatment of pain in patients with inflammatory arthritis (RA, AS).

    A randomized, double blinded, placebo controlled trial

    CAN-ART
    Smertebehandling med medicinsk Cannabis
    af patienter med inflammatorisk Artrit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can-Art
    Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine.
    A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.
    Can-Art
    Effekt og sikkerhed ved anvendelse af Canabis-derivater til behandling af smerte hos patienter med inflammatorisk arthritis, såsom rheumatoid arthritis og ankyloserende spondylitis (sidstnævnte er en type arthritis, der forårsager langvarig betændelse i rygsøjlen og bækkenet).
    En randomiseret, dobbeltblindet, placebokontrolleret forsøg, dvs. i denne lægemiddelforsøg, gives en kontrolgruppe en placebo, mens en anden gruppe får substansen, der undersøges, dvs. Cannabis derivatet.
    A.3.2Name or abbreviated title of the trial where available
    Can-Art
    A.4.1Sponsor's protocol code numberCan-Art1
    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 SponsorKing Christian 10th Hospital for Rheumatology
    B.1.3.4CountryDenmark
    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 The Danish Rheumatism Association
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Region of Southern Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing Christian 10th Hospital for Rheumatic Diseases
    B.5.2Functional name of contact pointDepartment of Research
    B.5.3 Address:
    B.5.3.1Street AddressToldbodgade 3
    B.5.3.2Town/ cityGraasten
    B.5.3.3Post code6300
    B.5.3.4CountryDenmark
    B.5.4Telephone number004573654045
    B.5.6E-mailkfrolich@gigtforeningen.dk
    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 nameCannabidiol tablet 10 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 nameDronabinol capsule 2.5. mg
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDRONABINOL
    D.3.9.1CAS number 1972-08-3
    D.3.9.4EV Substance CodeSUB06407MIG
    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 Yes
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis (RA)
    and Ankylosing Spondylitis (AS)
    E.1.1.1Medical condition in easily understood language
    RA and AS are autoimmune diseases. In RA the immune system attacks the membranes lining the joints, typically initially in small joints.
    AS affects the joints of the spine and the pelvic girdle.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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
    RA and AS are systemic autoimmune diseases characterized by chronic, systemic inflammatory conditions, primarily of the musculoskeletal system. Pain and fatigue are typical symptoms and their treatment is a clinical challenge. The present study aims to clarify the potential of medical cannabis as a complement to the existing treatment in RA and AS.

    More precisely, the study aims to clarify in RA and AS patients, whether the “add-on” treatment with CBD (placebo controlled) or the combination of CBD and THC (open label) results in a significantly improved pain situation as assessed by the number of patients achieving an improvement of pain visual analogue scores (VAS) with a reduction of Δ VAS > 20.
    E.2.2Secondary objectives of the trial
    A significantly improved pain situation as assessed by the number of AS patients that achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 40 and / or improvement in BASDAI with Δ > 20 after 12 and/ or 24 weeks of treatment with CBD or 12 weeks of treatment with CBD followed 12 weeks of treatment with the combination of CBD and THC in an open follow-up.

    A significantly improved life situation as assessed by the number of patients that achieve a Global VAS < 50 and / or an improvement in Global-VAS with Δ VAS> 20 after 12 and/ or 24 weeks of treatment with CBD or 12 weeks of treatment with CBD followed by 12 weeks of treatment with a combination of CBD and THC in an open follow-up study.

    The effect of the intervention on the patients attention and concentration is investigated using cognitive tests (Trail Making Test (TMT) and Digit Symbol Substitution Test (DSST)). Additionally, sleep quality is evaluated with the Pitssburgh Sleep Quality Index.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are patients diagnosed with seropositive RA, more specifically inflammatory well-treated patients, characterized by absence of arthritis at 40 counts and normal C-reactive protein (CRP) or with diagnosis AS in accordance with the modified New York criteria, i.e. based on physiotherapy and / or non-steroidal anti-inflammatory drugs (NSAIDs) and / or bDMARD inflammatory well-treated patients, characterized by absence of axial and peripheral arthritis as well as clinically detectable entesitis, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS < 2.1) and where normally CRP is documented.

    Participant with the above mentioned diagnoses and relevant clinical status quo, followed regularly at one of the four departments are invited to participate in the study. Furthermore:

    a. Receiving treatment on an outpatient basis
    b. Diagnosed for at least 2 years
    c. seropositive (anti CCP and/ or IgM RF) RA, radiology (MRI and/ or conventional X-ray) verified AS
    d. RA: a stable inflammatory treatment situation achieved by ongoing cDMARD and / or bDMARD, 40 joint count without joint swelling
    e. AS: a stable inflammatory treatment situation achieved by ongoing physiotherapy, NSAID, cDMARD and / or bDMARD: ASDAS < 2.1 for at least 4 weeks
    f. Ongoing or earlier attempt of treatment with Paracetamol or NSAIDs with the outcome of parameters as mentioned in item e. or f.
    g. Pain relief treatment unchanged at least 4 weeks before trial start
    h. Minimum Pain VAS 50

    E.4Principal exclusion criteria
    a. Age < 18 years
    b. Pregnancy or desiring pregnancy, ongoing breastfeeding
    c. CRP > 10 mg/L
    d. Swollen Joints
    e. Comorbidities, more specific competitive rheumatologic disorders such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma or polymyositis, chronic pain condition based on a further etiology (e.g. fibromyalgia)
    f. Severe competing cardiovascular, pneumological, neurological, endocrinological, gastro-enterological, urogenital or nephrological disorder
    g. Major surgery performed <8 weeks before randomization or planned major surgical interventions
    h. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
    i. Verified cancer
    j. Known actual or previous alcohol or drug abuse
    k. Ongoing treatment with opiods and / or cannabis products and / or neuroleptics, or treatment terminated less than 4 weeks before trial start
    l. Known hypersensitivity to the study compounds
    m. Suspected or known schizophrenia or other psychotic illness in the family history or other significant psychiatric disorder in addition to depression associated with underlying condition
    n. Epilepsy or recurrent seizures
    o. Use of strong CYP3A4 inducers, e.g. rifampicin, carbamazepine, phenytoin, phenobarbital and perforate St. Johns wort.
    p. severe hepatic/ renal impairment
    E.5 End points
    E.5.1Primary end point(s)
    The study investigates the effect of CBD, more specific whether the add-on treatment with CBD results in a significantly improved pain situation as assessed by the number of patients achieving an improvement of pain-VAS with a reduction of Δ VAS> 20. Assessment takes place after 12 and 24 weeks of active treatment with CBD.

    B. If the patient does not experience an acceptable effect of the CBD treatment in the assessment after 12 weeks (as defined by study protocol, i.e. pain VAS reduction > 20), the randomization is terminated and the treatment proceeds by a combination of CBD and THC.
    THC 2.5 mg daily in week 13 and 14, increasing to 5 mg (2.5 mg x 2 daily) in the following two weeks. If no effect has occurred after week 16, the dose increases in the beginning of the 17th week to the maximum of 7.5 mg THC (2.5 mg x 3 daily) in the 3rd week


    2. Thus, the study investigates the effect of the combination of CBD and THC, more specific whether the add-on treatment with CBD for 12 weeks followed by the combined treatment of CBD and THC for another 12 weeks results in a significantly improved pain situation as assessed by the number of patients achieving an improvement of pain-VAS with a reduction of Δ VAS> 20. Assessment takes place after 12 and 24 weeks of active treatment with CBD and after 12 weeks of active treatment with CBD followed by another 12 weeks combined treament with CBD and THC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During this study period, the participants are invited to four visits at one of the participating centers. At baseline and after 12 and 24 weeks( ± 7 days) respectively, the key data i.e. the pain VAS scores are determined and registered in the Danish nationwide quality registry DANBIO.

    Briefly the data are obtained at consultation visit 1 (baseline), a consultation visit at week 12 ± 7 days, another consultation visit at week 24 ± 7 days.
    Furthermore a follow up consultation visit will take place at week 36 ± 7 days and define this endpoint 12 weeks after the active treatment is terminated.

    E.5.2Secondary end point(s)
    Secondary outcomes
    1) Outcomes: Clinical measurements, i.e. in RA the Disease Activity Score 28-joints (DAS28-CRP), Health Assessment Questionnaire (HAQ) and in the case of AS the Ankylosing spondylitis disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis (BAS)-scores for disease activity (BASDAI), function (BASFI) and measures (BASMI) are registered . Patient Reported Outcome Measures (PROMs) more specific, visual analogue scales (VAS) for fatigue, patient’s global; the Quality of Life (QoL) - and pain- scores SF-36 and PainDETECT are obtained.
    Furthermore, the effect of intervention on attention and concentration is investigated using the following cognitive test: Trail Making Test (TMT) and Digit Symbol Substitution Test (DSST). Additionally, sleep quality is evaluated with the Pitssburgh Sleep Quality Index and the expected effect for treatment is measured with Credibility/expectancy Questionnare Devilly and semistructured course interviews.

    Thus, the study investigates the effect of CBD, more specific whether the add-on treatment with CBD results in a significantly improved fatigue situation and as well more holistic qulaity of life situation as assessed by the number of patients achieving an improvement of fatigue-VAS with a reduction of Δ VAS> 20 and an improvement of global-VAS with a reduction of Δ VAS> 20.
    Assessment takes place after 12 and 24 weeks of active treatment with CBD.

    Furthermore, the study investigates the effect of the combination of CBD and THC, more specific whether the add-on treatment with CBD for 12 weeks followed by the combined treatment of CBD and THC for another 12 weeks results in a significantly improved fatigue situation and as well more holistic qulaity of life situation as assessed by the number of patients achieving an improvement of fatigue-VAS with a reduction of Δ VAS> 20 and an improvement of global-VAS with a reduction of Δ VAS> 20.

    2) Exposures, i.e. current treatments with DMARDs and/or analgesics including dosing schedule and treatment onset.
    3) Patient demographics, e.g. diagnosis, age and gender, height, weight and Body Mass index (BMI)
    4) Comorbidities, e.g. cardiovascular disease, diabetes and hypertension
    5) Life-style (blood pressure, exercise habits and smoking status)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline and after 12 and 24 weeks( ± 7 days) respectively, the data are registered.
    Furthermore, the effect of intervention on attention and concentration is investigated using the following cognitive test: Trail Making Test (TMT) and Digit Symbol Substitution Test (DSST). Additionally, sleep quality is evaluated with the Pitssburgh Sleep Quality Index and the expected effect for treatment is measured with Credibility/expectancy Questionnare Devilly and semistructured course interviews take place at timepoints baseline and after 12 and 24 weeks.

    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) 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 concerned4
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state180
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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)
    The trial treatment is an "add-on" treatment, i.e. treatment regiments that already were established before the trial began, will continue according to national treatment guidelines after the trial has been terminated
    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 Decision2018-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-20
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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