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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2016-000615-33
    Sponsor's Protocol Code Number:CONSUL2016
    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:2016-07-06
    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 number2016-000615-33
    A.3Full title of the trial
    Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL)
    A.3.2Name or abbreviated title of the trial where available
    CONSUL
    A.4.1Sponsor's protocol code numberCONSUL2016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02758782
    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 SponsorCharite Universitaetsmedizin
    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 supportFederal Ministry of Education and Research
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharite Universitaetsmedizin
    B.5.2Functional name of contact pointRheumatology at Campus B Franklin
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12200
    B.5.3.4CountryGermany
    B.5.4Telephone number+493084454144
    B.5.5Fax number+493084454149
    B.5.6E-maildenis.poddubnyy@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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V., Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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: 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 Celebrex
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Gmbh, Berlin/Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule, hard
    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
    ankylosing spondylitis (AS)
    E.1.1.1Medical condition in easily understood language
    ankylosing spondylitis, Bechterew´s disease
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10041672
    E.1.2Term Spondylitis ankylosing
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10048398
    E.1.2Term Spondylitis ankylosing aggravated
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002557
    E.1.2Term Ankylosing spondylitis and other inflammatory spondylopathies
    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
    To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) – Celecoxib – when added to anti-tumour necrosis factor (TNF) therapy – Golimumab – as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with AS (Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial)
    E.2.2Secondary objectives of the trial
    • New syndesmophyte formation or progression of existing syndesmophytes after 2 years of treatment.
    • Improvement of disease activity, function, axial mobility and quality of life measures
    • Change of the bone and cartilage biomarkers serum levels and their relevance for the prediction of radiographic progression
    • Change of the enteric microbiome profile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Perfoming MRI of spine and sacroiliac joints in a subset of study patients at baseline and end of study. Aim: change of osteitis score and scores for the chronic post-inflammatory changes on magnetic resonance imaging (MRI) by Berlin MRI scoring method
    E.3Principal inclusion criteria
    1. Age ≥18 years.
    2. Definite diagnosis of AS according to the modified New York criteria1.
    3. History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each.
    4. Active disease as defined by a BASDAI value of ≥4 at screening and baseline.
    5. Presence of at least one of the following risk factors for radiographic spinal progression:
    • Elevated CRP (>5mg/l) at screening at the absence of reasons for elevated CRP other than AS;
    • Presence of ≥ 1 syndesmophyte on prior X-rays of the spine.
    6. Subject is a candidate for anti-TNF therapy based on the investigator’s opinion.
    7. Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.
    8. If female: either unable to bear children or is willing and able to practice a reliable method of contraception throughout the study and 6 months after the last dose of study drug
    9. If on NSAIDs: the dose must be stable for at least 2 weeks prior to baseline.
    10. If on oral steroids: the dose must not exceed 10 mg (prednisolone equivalent) per day and must be stable for at least 2 weeks prior to baseline.
    11. If on methotrexate: the dose must not exceed 25 mg per week and must be stable for at least 4 weeks prior to baseline.
    12. If on sulfasalazine: the dose must not exceed 3 g per day and must be stable for at least 4 weeks prior to baseline.
    13. If on analgesics: the dose must be stable for at least 2 weeks prior to baseline.

    Phase II of the study:
    1. Achievement of at least 50% improvement or >=2 absolute points (on a 0-10 scale) reduction of the BASDAI after 12 weeks of Golimumab treatment in the Phase I.
    E.4Principal exclusion criteria
    - for female subjects: pregnancy or lactating.
    - subjects with chronic inflammatory articular disease other than SpA or systemic autoimmune disease.
    - history of inadequate response (primary non-response) to previous anti-TNF therapy.
    - treatment with any other investigational drug within 3 months of 5 half-lifes of the drug (whichever is longer) prior to Baseline visit.
    - history of intolerability or hypersensitivity reaction study drugs
    - any active current infection. History of recurrent clinically significant infection (suggestive for primary or secondary immunodeficiency). Infections requiring treatment with antibiotics within 4 weeks prior to baseline.
    - current clinical signs and symptoms suggestive for tuberculosis.
    - positive QuantiFERON®-TB Gold In-Tube test at screening and/or abnormal chest x-ray (performed at screening or within 3 months prior to screening) suggestive for past or present tuberculosis (positive x-ray). Patients with a positive QuantiFERON®-TB Gold In-Tube test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic anti-tuberculous treatment.
    - chronic infection with hepatitis B or C, history of HIV infection.
    - malignancies
    - demyelinating disease (like multiple sclerosis; including myelitis)
    - history of cardiovascular events or high cardiovascular risk
    - history of GI ulceration or any clinically relevant GI bleeding, perforation, or gastric outlet obstruction.
    - History of a chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
    - evidence of other severe uncontrolled disorders.
    - diagnosis of fibromyalgia.
    - several abnormalities of laboratory values as defined in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Absolute progression of syndesmophytes as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years (weeks 12 to 108) of therapy in the core phase of the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and end of study
    E.5.2Secondary end point(s)
    • New syndesmophyte formation or progression of existing syndesmophytes after 2 years of treatment.
    • Improvement of disease activity, function, axial mobility and quality of life measures
    • Change of the bone and cartilage biomarkers serum levels and their relevance for the prediction of radiographic progression
    • Change of cellular and humoral markers of inflammation
    • Change of the enteric microbiome profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Syndesmophyte progression at baseline and end of study.
    disease activity, function, axial mobility and QOL at several timepoints troughout the study (questionnaires)
    bone and cartilage biomarkers and biomarkers of inflammation at several timepoints
    enteric microbiome at baseline and end of study.
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned21
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state170
    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 Decision2016-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-25
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