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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-004020-65
    Sponsor's Protocol Code Number:MK-8259-038
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-004020-65
    A.3Full title of the trial
    A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In
    Subjects With Non-Radiographic Axial Spondyloarthritis
    Klinische Prüfung der Sicherheit und Wirksamkeit von Golimumab (MK-8259) nach Absetzen der Behandlung im Vergleich mit einer Fortführung der Behandlung bei Patienten mit nicht-radiographischer axialer Spondyloarthritis (nr-axSpA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate the Efficacy and Safety of Golimumab in Subjects With Non-Radiographic Axial Spondyloarthritis
    Prüfung der Sicherheit und Wirksamkeit von Golimumab bei Patienten mit nicht-radiographischer axialer Spondyloarthritis
    A.3.2Name or abbreviated title of the trial where available
    Golimumab (MK-8259 / SCH 900259) in nr-axSpA: Withdrawal trial (GO-BACK)
    Golimumab (MK-8259/SCH 900259) bei nr-axSpA: Absetzstudie (GO-BACK)
    A.4.1Sponsor's protocol code numberMK-8259-038
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:12729
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGeorge Philip
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive PO Box 100
    B.5.3.2Town/ cityWhitehouse Stations
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305 5921
    B.5.6E-mailgeorge_philip@merck.com
    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 SIMPONI
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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 namegolimumab
    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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.2Current sponsor codeMK-8259
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Treatment of non-radiographic axial spondyloarthritis (nr-axSpA)
    E.1.1.1Medical condition in easily understood language
    Non-radiographic axial spondyloarthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In adults with active nr-axSpA who attain inactive disease after receiving open label golimumab during a 10-month run-in (Period 1): To evaluate the effect of treatment withdrawal vs continued treatment with golimumab (either QM or Q2M) on the incidence of a “flare” during up to 12 months of Period 2.
    E.2.2Secondary objectives of the trial
    In subjects who withdraw from or continue treatment with golimumab during Period 2:
    1.To characterize the proportion of subjects with a “flare” in the treatmentwithdrawal group or the reduced-treatment group who then show a clinical response after retreatment with open-label golimumab.
    2.To evaluate the time to first “flare” after withdrawal of golimumab vs continuous treatment with golimumab (either QM or Q2M).
    3.To evaluate the symptoms and signs of nr-axSpA (e.g., Assessment of SpondyloArthritis international Society [ASAS]20, ASAS40, BASDAI50, ASAS partial remission and ASDAS <1.3) after withdrawal of golimumab vs continuous treatment with golimumab (either QM or Q2M) and after re-treatment with openlabel golimumab if needed for a “flare”.
    4.To characterize the safety and tolerability of golimumab treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1.Be male or female and must be ≥ 18 to ≤ 45 years of age
    2.Be able to provide written informed consent for the trial and may also provide consent for Future Biomedical Research. However, the subject may participate in the trial without participating in Future Biomedical Research
    3.Meet one of the following categories:
    a) The subject is not of reproductive potential, defined as a male who has azoospermia OR as a female who is either: (1)Postmenopausal (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion; OR (3) has a congenital or acquired condition that prevents childbearing.
    b) The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication by complying with one of the following: (1) practice abstinence† from heterosexual activity OR (2) use (or have their partner use) acceptable contraception during heterosexual activity.
    Acceptable methods of contraception are defined in the protocol.
    4.Have chronic back pain of ≥3 months duration by history
    5.Have a physician’s diagnosis of active nr-axSpA with disease duration ≤5 years
    6.Meet either criterion “a” or “b” as adopted from ASAS classification criteria: a)Active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the spondyloarthritis
    characteristics as described in the protocol. b)HLA-B27+ gene and 2 or more of the spondyloarthritis characteristics as described in the protocol
    7.Have elevated CRP at the Screening visit or evidence of active inflammation in the SI joints on MRI
    8.Have ASDAS ≥2.1 at the Screening visit
    9.Show high disease activity at Screening and Baseline of both a Total Back Pain score of ≥4 and a BASDAI score of ≥4 (each on a NRS of 0 to 10)
    10.Have an acceptable history of use of NSAIDs: either an inadequate response, as assessed by the investigator, with maximal recommended daily doses of at least 2 NSAIDs; or must be unable to receive maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs. (Note: It is possible that a subject had a good response initially to NSAIDs but subsequently had inadequate response or developed intolerance to NSAIDs therapy)
    11.Have acceptable current use of NSAIDs at Screening: a)If currently using an NSAID, must be on a stable daily dose for at least 14 days prior to Screening b)If not currently using an NSAID, short-term use is allowed (up to 1 week) during Period 1 and is allowed as needed during Period 2
    12.Have no history of untreated latent or active tuberculosis
    13.Be judged to be medically stable, other than nr-axSpA, based on medical history, physical examination, and routine laboratory tests
    14.Undergo screening for hepatitis B virus (HBV), which at a minimum includes testing for HBV surface antigen (HBsAg), HBV surface antibody (anti-HBs), and HBV core antibody (anti-HBc total), and demonstrate to be eligible based on the results as described in the protocol
    E.4Principal exclusion criteria
    1.Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays (to exclude subjects who meet modified New York criteria for AS)
    2.If female, is nursing, pregnant, or intending to become pregnant within 6 months after receiving the last administration of trial medication
    3.Intends to donate eggs (female subjects) or sperm (male subjects) while receiving trial medication or within 6 months after the last dose of trial medication.
    4. Has any clinically significant condition or situation, other than those listed as exclusion criteria that, in the opinion of the investigator, would interfere with the trial evaluations or participation in the trial
    5.Has ever received any cytotoxic drugs, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
    6.Has received any treatment as described in the protocol more recently than the indicated offdrug period prior to Screening
    7.Has ever received TNF-α targeted therapy or any other biological agents intended to treat immune-mediated diseases, including but not limited to infliximab, etanercept, adalimumab, certolizumab, golimumab, alefacept, efalizumab, rituximab, natalizumab, secukinumab, ixekizumab, ustekinumab, or vedolizumab
    8.Has an allergy/sensitivity to golimumab or its excipients
    9.Has any systemic inflammatory condition from Screening up to Baseline with signs and symptoms including, but not limited to: a. psoriatic arthritis, b. active Lyme disease, c. systemic lupus erythematosus, d. infectious arthritis, e. vasculitis, f. parvovirus infection, g. rheumatoid arthritis, h. active uveitis,
    i. active IBD
    10.Has a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to Screening
    11.Had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, Pneumocystis jirovecii [carinii], aspergillus) within 6 months prior to Screening
    12.Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
    13.Had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), or has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to Baseline. Less serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator
    14.Had a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound, or an ulcer
    15.Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)
    16.Has a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive of a current active infection or malignancy
    17.Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location and/or clinically significant splenomegaly, or monoclonal gammopathy of undetermined significance
    18.Has had a malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin that have been treated, with no evidence of recurrence for at least 3 months prior to Baseline; and carcinoma in situ of cervix that has been surgically cured)
    19.Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
    20.Has a history of or concurrent congestive heart failure ([CHF] of any grade [I IV]), including medically controlled, asymptomatic CHF
    21.Has a transplanted organ (with the exception of a corneal transplant performed ≥3 months prior to baseline)
    22.Has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiovascular, metabolic, ophthalmological, respiratory, hematologic, gastrointestinal, endocrine, pulmonary, neurologic, psychiatric, cerebral, or other significant medical illness or disorder that, in the judgment of the investigator, could interfere with the trial, or require treatment that might interfere with the trial. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
    23.Is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years
    24.Has participated in any other interventional clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects without a “flare” during up to 12 months in Period 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months of Period 2
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    10-month open label period
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Germany
    Netherlands
    Poland
    Russian Federation
    Spain
    Turkey
    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 months7
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days20
    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: 300
    F.1.3Elderly (>=65 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 300
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-17
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