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    The EU Clinical Trials Register currently displays   36120   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-000311-34
    Sponsor's Protocol Code Number:P07642
    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:2011-10-11
    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 number2011-000311-34
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study of
    the Effect of Golimumab Administered Subcutaneously in Subjects with
    Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also
    known as MK-8259-006-00).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GO-AHEAD
    A.3.2Name or abbreviated title of the trial where available
    GO-AHEAD
    A.4.1Sponsor's protocol code numberP07642
    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 SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    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., USA
    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., USA
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressLindenplatz 1
    B.5.3.2Town/ cityHaar
    B.5.3.3Post code85540
    B.5.3.4CountryGermany
    B.5.4Telephone number+498945611251
    B.5.5Fax number+49894561281418
    B.5.6E-mailstefan.beeck@msd.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.
    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 nameSIMPONI
    D.3.2Product code MK-8259 / SCH 900259
    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.3.9.4EV 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 Yes
    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
    Active Axial Spondyloarthritis (SpA)
    E.1.1.1Medical condition in easily understood language
    Axial SpA
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041672
    E.1.2Term Spondylitis ankylosing
    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 effect of golimumab50 mg compared to placebo in the treatment of active axial SpA, as measured by proportion of subjects achieving Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16 and to demonstrate the safety and tolerability of golimumab 50 mg through Week 16 in the active axial SpA population.
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of golimumab 50 mg compared to placebo as measured by the proportion of subjects achieving ASAS 40 response at Week 16.

    To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response at Week 16.

    To evaluate the treatment effect of golimumab 50 mg compared to placebo, as measured by the proportion of subjects who achieve ASAS partial remission at Week 16.

    To evaluate the treatment effect of golimumab 50 mg compared to placebo by the change in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) joints scoring from Baseline to Week 16.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Each subject must be ≥18 to ≤45 years of age.
    2. Each subject must have a physician’s diagnosis of active axial SpA with disease duration ≤5 years, and chronic back pain of ≥3 month duration.
    3. Each subject must meet either criterion “a” or “b” as adopted from ASAS classification criteria:
    a. Active inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthropathy (as evidenced by the central reader) and 1 or more of the following spondyloarthritis characteristics OR
    b. HLA-B27+ gene and 2 or more of the following spondylarthritis characteristics (not including HLA-B27):
    ◦ Inflammatory back pain, defined as having at least 4 out of the 5 following parameters:
     age at onset < 40 years;
     insidious onset;
     improvement with exercise;
     no improvement with rest;
     pain at night (with improvement upon getting up);
    ◦ Arthritis diagnosed by a physician;
    ◦ Enthesitis diagnosed by a physician;
    ◦ Dactylitis diagnosed by a physician;
    ◦ Psoriasis diagnosed by a physician;
    ◦ History of inflammatory bowel disease (IBD) diagnosed by a physician;
    ◦ History of uveitis confirmed by an ophthalmologist;
    ◦ Good response to NSAIDs
    ◦ Family history for SpA;
    ◦ Elevated CRP (> upper limit of normal based on central lab values);
    ◦ HLA-B27+ gene;
    4. Each subject must show high disease activity at Screening and Baseline of both a total back pain evaluation of ≥40 mm on a VAS of 0-100 mm and a BASDAI score of ≥ 40 mm.
    5. Each subject must have either an inadequate response (as assessed by the investigator) to 30 days of continuous therapy with maximal recommended daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a maximal dose of NSAID therapy for a full 30 days because of intolerance, toxicity, or contraindications to NSAIDs.
    E.4Principal exclusion criteria
    1. The subject has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional X-rays (ie, excluding modified New York criteria) based on central reading at Screening.
    2. The subject has ever received TNF-α targeted therapy or any biological agents, including but not limited to infliximab, etanercept, adalimumab, alefacept or efalizumab, rituximab, or natalizumab.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for the trial is the proportion of subjects meeting the ASAS 20 response at Week 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    The Key Secondary Efficacy Endpoints are:
    • Proportion of subjects meeting the ASAS 40 response at Week 16;
    • Proportion of subjects achieving BASDAI 50 at Week 16;
    • Proportion of subjects in ASAS partial remission at Week 16;
    • Change in SPARCC MRI SI joints scoring from Baseline to Week 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Canada
    Czech Republic
    Denmark
    Germany
    Greece
    Ireland
    Italy
    Norway
    Russian Federation
    Spain
    Turkey
    United Kingdom
    United States
    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
    The overall trial ends when the last remaining subject has ended participation in the trial, by completing the trial, being discontinued from the trial, or being lost to follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 225
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 225
    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)
    Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment of that condition.
    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 Decision2011-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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