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    Summary
    EudraCT Number:2019-004359-35
    Sponsor's Protocol Code Number:ICEA2020.1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004359-35
    A.3Full title of the trial
    Induction of Cure in Early Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Induction of Cure in Early Arthritis
    A.3.2Name or abbreviated title of the trial where available
    I CEA
    A.4.1Sponsor's protocol code numberICEA2020.1
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NL8195
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportEli Lilly
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointDepartment of Rheumatology
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031(0)715263423
    B.5.5Fax number0031(0)715266752
    B.5.6E-mailc.f.allaart@lumc.nl
    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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEuropean Union
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    early unclassified arthritis
    E.1.1.1Medical condition in easily understood language
    Joint inflammation with unknown cause
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10062164
    E.1.2Term Seronegative arthritis
    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
    Primary Objectives:
    … to establish
    - which is the best strategy to ensure early remission (within 3 months) of early unclassified arthritis (UA): early treatment with MTX or baricitinib or delayed treatment in case spontaneous remission does not occur within 3 months.
    - which is the best strategy to achieve cure (or sustained drug free remission) of recent onset UA: early treatment with MTX or baricitinib
    E.2.2Secondary objectives of the trial
    To establish
    - which is the best treatment, MTX or baricitinib, to ensure rapid symptom relief of recent onset undifferentiated arthritis
    -which is the best treatment to prevent (or delay) progression of early unclassified arthritis to rheumatoid arthritis
    -which is the best treatment in terms of patients’ (in)tolerance of medication and reported side effects and drug toxicity over time
    -which is the best treatment to ensure optimal functional ability over time
    -which is the best treatment in terms of patients’ satisfaction with treatment after 3 months on NSAIDs, MTX or baricitinib
    -which is the best option in patients who achieve remission on baricitinib: stop baricitinib as soon as remission is achieved, or continue for 6 more months to prevent relapse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥18 year of age and able to give written informed consent (in Dutch or English) and fill out questionnaires in Dutch (or English version, if available)
    - Clinical early unclassified arthritis of at least one joint, not fulfilling ACR/EULAR 2010 criteria for rheumatoid arthritis
    - Symptom duration of arthritis <1 year
    - Other diagnoses causing the arthritis rejected (including infection, (pseudo-)gout, psoriatic arthritis, non-rheumatoid auto-immune disease, paraneoplastic arthritis)
    - DAS>1.6
    - No wish to become pregnant, breastfeed or father a child during the study
    - No contraindications to treatment with NSAIDs, MTX (or sulfasalazine or leflunomide as alternative) and baricitinib as required in the study
    E.4Principal exclusion criteria
    - Alcohol or substance abuse
    - Immuno-compromised state either based on co-morbidity or co-medication
    - Leucopenia <3*10^9/l, and/or neutropenia <1*10^9/l
    - Hemoglobin <5 mmol/l
    - Increased liver enzymes > 3x upper limit of normal
    - Renal insufficiency with estimated creatinine clearance <40%
    - Interstitial lung disease as seen on X-thorax
    - Maintenance treatment with corticosteroids exceeding prednisone 10 mg daily or equivalent
    - Active or ongoing chronic infection, (recurrent) serious infection(s) in past 4 months, latent TB who refuse anti-tuberculous treatment, hepatitis B with positive DNA viral load or hepatitis C with positive RNA viral load, patients with anti-HB2 and anti-HBc antibodies who refuse monitoring of hepatitis B DNA expression
    - Increased tendency to develop arterial or venous thrombosis. Assessed by the treating rheumatologist based on family history and medical history of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients in early clinical remission (Definition of clinical remission: DAS<1.6 by independent assessor, or DAS>1.6 by independent assessor but no clinical arthritis according to treating rheumatologist)
    - Percentage of patients in sustained drug free remission (at least 6 consecutive months in clinical remission without DMARD and corticosteroids)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage of patients in early clinical remission at 3 months.
    Percentage of patients in sustained drug free remission at 18 months.
    E.5.2Secondary end point(s)
    Disease Activity Score (DAS) based on a 44 swollen joint count including a 53 joint Ritchie Articular Index.
    Functional ability as measured by the Health Assessment Questionnaire (HAQ)
    Physical and emotional wellbeing as measured by the ShortForm-36 (SF-36)
    Functional ability in preferred activities as measured by the MACTAR
    Quality of life as measured by the EuroQol 5-dimensional questionnaire (EQ-5D)
    Neuropathic pain as measured by the PainDETECT questionnaire (PDQ)
    Illness perception as measured by the IPQ-K (brief illness perception questionnaire)
    Toxicity as defined by number and severity of adverse events based on routine laboratory tests as required for study medications, open end questioning during study visits, and interim reports of adverse events
    Local joint pain as measured on a 100 mm Visual Analogue Scale (VAS), measuring from 0 (no pain) to 100 (maximum imaginable pain)
    General fatigue as measured on a 100 mm VAS (no to maximum)
    Morning stiffness as measured on a 100 mm VAS (no to maximum)
    General functional disability as measured on a 100 mm VAS (no to maximum)
    General satisfaction with medication use (convenience) as measured on a 100 mm VAS (no to maximum).
    General dissatisfaction with medication use as measured on a 100 mm VAS (no to maximum).
    The extent to which benefits of medication use are more important than downsides as measured on a 100 mm VAS (no to maximum).
    Disease activity as assessed by the treating rheumatologist on a 100 mm VAS at 3 months and 12 months and over time.
    Feelings of depression as measured with the Beck’s Depression Inventory.
    Time to clinical remission from baseline and per drug (MTX or baricitinib) from start of treatment
    Time to clinical improvement (by patient diary and clinical assessments at weeks 2,4 and 8)
    Progression to classifiable RA (2010 criteria) over time from baseline
    Time to flare (from absence of any arthritis to at least one joint with active arthritis)
    (Progression of) radiologic damage as measured with the Sharp-vanderHeijde Score (baseline, 6, 12 and 18 months).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 2, week 4, week 8 and then 3-monthly up to 18 months follow-up: DAS, HAQ, SF36, VAS scales, treatment satisfaction, clinical remission, RA classification, time to flare
    Baseline, 3 months, 18 months: MACTAR, EQ-5D, Beck's Depression Inventory,
    Baseline, week 2, 3 months, 18 months: PainDETECT
    week 2, week 4, week 8 and then 3-monthly up to 18 months follow-up: toxicity
    Baseline, week 2, week 4, week 8: time to clinical improvement
    Baseline, 6, 12 and 18 months: Sharp-vanderHeijde Score
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    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 Yes
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 245
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state309
    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)
    None
    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 STRO
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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