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    Summary
    EudraCT Number:2016-000235-40
    Sponsor's Protocol Code Number:STATIC-2016-000235-40
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2016-06-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-000235-40
    A.3Full title of the trial
    Stopping anti-TNF treatment in Crohn’s and Colitis patients in remission
    Utsättning av anti-TNF terapi hos patienter med ulcerös kolit eller Crohns sjukdom i lugn fas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stopping anti-TNF treatment in Crohn’s and Colitis patients in remission
    Utsättning av anti-TNF terapi hos patienter med ulcerös kolit eller Crohns sjukdom i lugn fas
    A.3.2Name or abbreviated title of the trial where available
    The StatiC study
    A.4.1Sponsor's protocol code numberSTATIC-2016-000235-40
    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 SponsorRegion Skåne
    B.1.3.4CountrySweden
    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 supportALF-medel
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Skåne
    B.5.2Functional name of contact pointJan Marsal
    B.5.3 Address:
    B.5.3.1Street AddressGastrokliniken Lund, Skånes Universitetssjukhus EA12
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46046177003
    B.5.6E-mailjan.marsal@med.lu.se
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    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.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 Yes
    D.2.1.1.1Trade name Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    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 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: 3
    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 Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    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 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: 4
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Solution for injection in pre-filled pen
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn´s disease
    Ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Crohn´s disease
    Ulcerative colitis
    Crohns sjukdom
    Ulcerös kolit
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    The aim is to identify clinical and biological markers that offer guidance as to which patients successfully may discontinue maintenance anti-TNF treatment, and which patients on the contrary need to continue treatment over an extended period of time in order to remain in remission.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For patients with ulcerative colitis:
    • Diagnosis: Ulcerative colitis
    • Age 18-80 years.
    • Male or female.
    • IFX or ADA treatment since >12 months; last 3 doses at the same dose and interval. If the patient is on a biosimilar-infliximab the patient must have received at least 3 doses, and at the same dose and interval.
    • SCCAI score of ≤3.
    • Endoscopic Baron score of 0-1. The most inflamed part in the rectum/ sigmoid colon is evaluated. A minimum of 40 cm of the colon should be examined.

    For patients with Crohn's disease:
    • Diagnosis: Crohn's disease
    • Age 18-80 years.
    • Male or female.
    • IFX or ADA treatment since >12 months; last 3 doses at the same dose and interval. If the patient is on a biosimilar-infliximab the patient must have received at least 3 doses, and at the same dose and interval.
    • Simplified HBI (sHBI; abdominal palpation excluded) score of ≤4.
    • Simplified Endoscopic Score for CD (SES-CD) of ≤4 and no ulcer ≥5 mm other than a potential anastomotic ulcer (ie apthous ulcers allowed).
    • F-calprotectin <200 mg/kg (PhiCal) or <350 mg/kg (Buhlmann).
    E.4Principal exclusion criteria
    For patients with ulcerative colitis:
    • Corticosteroid (rectal or systemic) or rectal 5-ASA treatment during the last 6 months.
    • Colonic resection.
    • Pregnancy.

    For patients with Crohn's disease:
    • Documented engagement/inflammation of the small bowel proximally of a level of 50 cm from the ileocecal valve. Any examination modality is accepted, and a current/new small intestinal examination is not required. A limited number of small (<5 mm) lesions on capsule endoscopy allowed.
    • Corticosteroid (rectal or systemic) or rectal 5-ASA treatment during the last 6 months.
    • Colonic surgery with removal of more than half of the transverse colon.
    • Pregnancy.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients that relapses, as defined by symptomatic scoring in combination with endoscopy, at 12 and 24 months after discontinuation of anti-TNF treatment with identification of factors at study-start that correlate positively or negatively with the event of relapse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    time-points 12 and 24 months
    E.5.2Secondary end point(s)
    • Endoscopic scores at 12 and 24 months among those who relapsed compared to those who remained in remission.
    • Fecal calprotectin levels at 12 and 24 months among those who relapsed compared to those who remained in remission.
    • Fecal calprotectin levels at study start among ulcerative colitis patients who relapsed compared to those who remained in remission.
    • The rate of relapse among ulcerative colitis patients with the following fecal calprotectin level ranges (<30 mg/kg for Calpro [C] and <60 mg/kg for Buhlmann [B]; 30-99 mg/kg C and 60-199 mg/kg B; 100-299 mg/kg C and 200-599 mg/kg B; ≥300 mg/kg C and ≥600 mg/kg B.
    • The optimal fecal calprotectin level cut-off with regards to sensitivity and specificity for relapse, for ulcerative colitis and Crohn's disease patients, respectively.
    • Trough concentrations of infliximab and adalimumab among those who relapsed compared to those who remained in remission.
    • The rate of relapse among those with undetectable infliximab or adalimumab trough concentrations, those with 0.5-2.9 ug/ml, 3.0-7.0 ug/ml, >7.0 ug/ml for infliximab, and ≥10.0 ug/ml for adalimumab.
    • The optimal trough concentration cut-off with regards to sensitivity and specificity for relapse, for infliximab and adalimumab, respectively.
    • Area under the infliximab or adalimumab concentration curve during the last therapy cycle among those who relapsed compared to those who remained in remission.
    • Presence of anti-drug antibodies among those who relapsed compared to those who remained in remission.
    • The rate of relapse among those with anti-drug antibodies versus those without.
    • Time to relapse among those who relapse, comparing ADA versus IFX treated and UC versus CD.
    • The level of gut microbiota dysbiosis among those who relapsed compared to those who remained in remission.
    • The rate of relapse among those with a dysbiosis score of 1, 2-3, and 4-5, respectively.
    • Correlation analyses of genes showing high versus low expression in mucosal biopsies and blood samples, with the event of relapse.
    • Correlation analyses of gene-variants with the event of relapse.
    • Additional factors that will be correlated with relapse rates: Endoscopic scores (Baron score 0 versus 1 for UC and SES-CD 0-1 versus 3-4 for Crohn's disease); corticosteroid use between 12 and 6 months before baseline; previous anti-TNF treatment; dose intensification of anti-TNF treatment; mono- versus concomitant immunomodulator-treatment; previously maximal inflammatory extent (Montreal classification); disease duration (<2 years, <5 years, <10 years, >10 years); extraintestinal manifestations; gender; smoking; hemoglobin; white blood cell count; platelet count; CRP; and histology/immunohistochemistry (basal plasmocytosis and numbers of different leukocyte and lymphocyte subpopulations).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 12 and 24 months
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Therapy de-escalation
    Terapiutsättning
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned23
    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 years4
    E.8.9.1In the Member State concerned months
    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: 332
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-06-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state350
    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, other than expected normal treatment
    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 Decision2016-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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