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    Summary
    EudraCT Number:2017-005151-83
    Sponsor's Protocol Code Number:MUCUS
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-09
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-005151-83
    A.3Full title of the trial
    INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Crohn's disease with Ustekinumab in clinical practice
    A.3.2Name or abbreviated title of the trial where available
    MUCUS
    A.4.1Sponsor's protocol code numberMUCUS
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointNational Coordinator (LKP)
    B.5.3 Address:
    B.5.3.1Street AddressCharitépl. 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450553836
    B.5.5Fax number+4930450553983
    B.5.6E-mailandi.fischer@charite.de
    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 STELARA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameStelara
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 STELARA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameStelara
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the real world effectiveness of ustekinumab (routine care) as combined clinical and endoscopic response in week 52.
    E.2.2Secondary objectives of the trial
    - to examine the robustness of the primary endpoint analysis, sensitivity analyses of the primary endpoint will be conducted.
    Evaluate the real world effectiveness (routine care):
    - in achieving and maintaining endoscopic remission.
    - in improving endoscopic and clinical indexes.
    - in achieving and maintaining of mucosal healing.
    - in achieving and maintaining clinical remission.
    - in achieving and maintaining steroid free clinical remission.
    - in achieving and maintaining clinical response.
    - in controlling perianal disease activity in subjects with active fistulizing Crohn’s disease at baseline
    - on serum CRP and albumin, as well as fecal calprotectin levels.
    - on health-related quality of life and patient-reported outcomes (PRO-2 soft stool frequency over past week abdominal pain over past week)
    - on extraintestinal manifestations and/or phenotype
    - describe the safety of real world ustekinumab use at every study visit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years of age
    2. Have active, moderate to severe, ileal and/or colonic CD, demonstrated by: HBI score of ≥ 5 at Baseline; Endoscopy with evidence of active CD (defined as SES-CD score ≥3 excluding the contribution of the narrowing component score) obtained within the 2-week screening period. A prior endoscopy may be used only if obtained within 3 months prior to baseline (Week 0), in which case the prior endoscopy must be centrally read again and SES-CD calculated based on this second, centralized read-out.
    3. Has had an inadequate response with, lost response to, was intolerant to, or had medical contraindications to one or more previous biologic therapies approved for the treatment of CD in Germany (ie, infliximab, adalimumab or vedolizumab) or had an inadequate response to conventional therapy (no biological treatment).
    4. Adhere to the following requirements for concomitant medication for the treatment of CD. The following medications are permitted provided doses meeting the requirements below are stable for or have been discontinued at least 3 weeks prior to baseline (Week 0), unless otherwise specified:
    a. Oral 5-aminosalicylic acid (5-ASA) compounds; b. Oral corticosteroids (eg, prednisone, budesonide) at a prednisone-equivalent dose of ≤40 mg/day or ≤9 mg/day of budesonide. Subject must be willing to taper corticosteroids; c. Antibiotics being used as a primary treatment of CD; d. Conventional immunomodulators (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]). Subjects must have been taking them for≥12 weeks, and on a stable dose for a least 4 weeks prior to baseline.
    5. Are eligible according to tuberculosis (TB) infection screening criteria.
    6. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    7. A woman of childbearing potential must have a negative highly sensitive serum (β -human chorionic gonadotropin [β-hCG]) pregnancy test at screening, and a negative urine pregnancy test at Week 0.
    8. Contraceptive use by men or women should be consistent with German Federal or State regulations regarding the use of contraceptive methods for subjects participating in clinical studies. Before inclusion, a woman must be either: a. Not of childbearing potential defined as: Premenarchal; Postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level) (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Permanently sterile (Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.)
    b. Of childbearing potential and: practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly). Examples of highly effective contraceptives included in protocol (page 27); agrees to remain on a highly effective method throughout the study and for at least 15 weeks after the last dose of ustekinumab. Note: If the childbearing potential changes after the start of the study or the risk of pregnancy changes (eg, a woman who is not heterosexually active becomes active,) a woman must begin a highly effective method of contraception, as described throughout the inclusion criteria.
    9. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 15 weeks after the last ustekinumab administration.
    10. During the study and for 15 weeks after receiving the last dose of ustekinumab, in addition to a highly effective method of contraception, a man
    • who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository)
    • must agree not to donate sperm.
    11. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    E.4Principal exclusion criteria
    1. Has complications of CD such as symptomatic strictures or stenoses, short bowel syndrome, or any other manifestation that might be anticipated to require immediate surgery, could preclude the use of the HBI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab.

    2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.

    3. Has previously received a biologic agent targeting IL-12 and/or IL-23, including but not limited to ustekinumab.

    4. Has received any of the following prescribed medications or therapies within the specified period: a. Non-autologous stem cell therapy or biologic agents that deplete B or T cells <12 months prior to baseline.
    b. Any investigational drug within 4 weeks before first administration of ustekinumab or within 5 half-lives of the investigational drug, whichever is longer.

    5. Has received a Bacille Calmette-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks of baseline.

    6. Have a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.

    7. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers.

    8. Has current signs or symptoms of infection. Established non-serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.

    9. Has a history of serious infection (eg, sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, for 8 weeks prior to baseline.

    10. Has any contraindication according to the German ustekinumab label.

    11. Has evidence of a herpes zoster infection ≤8 weeks prior to baseline.

    12. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. Refer to inclusion criteria for information regarding eligibility with a history of latent TB.

    13. Has evidence of current active infection, including TB, or a nodule suspicious for lung malignancy on screening or any other available chest radiograph, unless definitively resolved surgically or by additional imaging and with source document confirmation.

    14. Has or ever has had a nontuberculous mycobacterial infection or serious opportunistic infection (eg, cytomegalovirus colitis, Pneumocystis carinii, aspergillosis).

    15. Is known to be infected with HIV, hepatitis B, or hepatitis C. Testing at screening is mandatory and must be documented.

    16. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.

    17. Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

    18. Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening).

    19. Has previously undergone allergy immunotherapy (administration of an antigen) for prevention of anaphylactic reactions.

    20. Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients, or an allergy to latex (refer to the German label “Fachinformation”).

    21. Is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 15 weeks after the last dose of ustekinumab

    22. Is a man who plans to father a child while enrolled in this study or within 15 weeks after the last dose of ustekinumab.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response (Harvey Bradshaw index score reduction ≥ 3 points from baseline) AND endoscopic response (50% reduction of SES-CD from baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    - Sensitivity analysis of the clinical response (Harvey Bradshaw index score reduction ≥ 3 points from baseline) AND endoscopic response (50% reduction of SES-CD from baseline)
    - Endoscopic remission defined as a SES-CD score ≤2 at Week 26 (optional) and Week 52
    - Changes in score from baseline for the Harvey Bradshaw index and SES-CD questionnaire at Weeks 26 and 52.
    - Mucosal healing defined as the complete absence of mucosal ulcerations in any ileocolonic segment at Week 26 and Week 52
    - Clinical remission as defined by a Harvey Bradshaw index score of ≤ 4. It will be assessed at Weeks 8, 16, 26, 36, 52.
    - Steroid free clinical remission as defined by a Harvey Bradshaw index score of ≤ 4and the absence of concomitant steroid therapy in subjects who were on steroids at baseline. It will be assessed at Weeks 8, 16, 26, 36, 52.
    - Clinical response as defined as a Harvey Bradshaw index score reduction ≥ 3 points. It will be assessed at Weeks 8, 16, 26, 36, 52.
    - The PDAI will be used. Fistula response (yes / no) and remission (yes / no) will be assessed compared with baseline reading. 0 = remission. <4 (inactive disease not requiring therapy) ≥4 (active disease requiring medical or surgical therapy).
    - Serum CRP
    - Serum albumin
    - Fecal Calprotectin on Weeks 0, 8, 16, 26, 36, 52
    - Changes from baseline for European quality of life 5 dimensions 5 level (EQ-5D-5L) on Weeks 0, 8, 16, 26, 36, 52
    - PRO-2: remission, mild, moderate, severe (<8, 8–13, 14–34, >35) on Weeks 0, 8, 16, 26, 36, 52
    - Phenotype according to Montreal classification will be recorded on Weeks 0, 8, 16, 26, 36, 52
    - Presence and activity of extraintestinal manifestations will be recorded on Weeks 0, 8, 16, 26, 36, 52
    - Adverse events according to MedDRA terminology
    - Clinical laboratory data
    - Vital signs
    - Physical examination findings on Weeks 0, 8, 16, 26, 36, 52.
    - Record steroid tapering dose at all visits with concomitant medications
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 8, 16, 26, 36, 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 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
    Real world effectiveness (routine care)
    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 concerned10
    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: 90
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Patients who complete the study (i.e., are not early withdrawn due to discontinuation of ustekinumab) will continue to be prescribed ustekinumab at the discretion of their doctor.
    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 Decision2018-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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