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    Summary
    EudraCT Number:2010-022378-15
    Sponsor's Protocol Code Number:VT-4001-001-SP
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-022378-15
    A.3Full title of the trial
    VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate.
    A.3.2Name or abbreviated title of the trial where available
    VELVET
    A.4.1Sponsor's protocol code numberVT-4001-001-SP
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNycomed GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameVeltuzumab solution 75mg/ml
    D.3.2Product code hA20 (Immu-106)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNVeltuzumab
    D.3.9.1CAS number 728917-18-8
    D.3.9.2Current sponsor codehA20, IMMU-106
    D.3.9.3Other descriptive namehumanised anti-CD 20 antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number70 to 80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    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
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy and safety of three different sc doses of the humanized anti-CD20 antibody veltuzumab as an add-on treatment to MTX over 24 weeks compared to MTX alone
    E.2.2Secondary objectives of the trial
    To identify the dosage(s) of veltuzumab with the most favourable benefit-risk-ratio to be further evaluated in the subsequent Phase II/III clinical program in patients with moderate to severe RA.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Nested pharmacokinetic and exploratory biomarker study in a subset of 60 patients
    E.3Principal inclusion criteria
    • Written informed consent obtained before any trial-related activities
    • Outpatient, male or female, at least 18 years of age at Screening
    • Active rheumatoid arthritis. Diagnosis of RA using the ACR criteria for the classification of RA for at least 6 months prior to trial entry (based on swollen and tender joint count; CRP and/or ESR; RF and/or anti-CCP)
    • An inadequate response to previous or current treatment with either MTX alone or a combination of MTX with other DMARDs or biologic agents.
    • Receiving MTX 15-25 mg/week (oral or parenteral) for at least 20 weeks, including the last 6 weeks prior to Baseline at a stable dose
    • Subjects of reproductive potential (females and males) must agree to use effective double-method contraception
    • Female subjects must not be actively breast-feeding
    E.4Principal exclusion criteria
    Medical history/concurrent diseases
    Joints
    • Subjects who are wheel chair or bed bound
    • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
    • History of or current inflammatory joint disease other than RA
    • Septic prosthetic joint within the last 48 weeks prior to Baseline or indefinitely if the prosthesis concerned remains in situ.

    Infectious diseases
    • Primary or secondary immunodeficiency, including human immunodeficiency virus (HIV) infection
    • Evidence of acute or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
    • Evidence and/or history of active tuberculosis (TB), prior to successfully completing an anti-TB treatment. Subjects with latent TB infection (LTBI) can be included
    • Acute clinical manifestations of herpes zoster virus and history of severe herpes zoster
    • History of active infection of any kind or any major episode of infection requiring hospitalisation or treatment with iv anti infective agents within 6 weeks prior to Baseline or oral anti-infective agents within 2 weeks prior to Baseline
    • History of deep space/tissue infection within 48 weeks prior to Baseline
    • History of osteomyelitis
    • History of sepsis of any origin requiring intensive care
    • History of serious recurrent or chronic infections not specified above.

    Cardio-pulmonary
    • Any significant cardiac disease
    • History of severe chronic obstructive pulmonary disease (COPD) and/or history of severe COPD exacerbation(s) within the last 12 months prior to Screening .

    Immune system/haematology/biochemistry
    • History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of veltuzumab injection solution
    • Subjects with CD4 cell counts (< 250/µl) at Screening
    • Hypogammaglobulinemia (IgG < 5.0 g/L, and/or IgM < 0.20 g/L) at Screening
    • Splenectomy
    • Subjects with haemoglobin < 9.0 g/dL, white blood cell (WBC) count < 3000 cells/µL, absolute neutrophil count (ANC) < 2000 cells/µL, lymphocyte count < 800 cells/µL or platelet count < 100,000/µL at Screening
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT) or alkaline phosphatase levels > 2.0 times the upper limit of normal (ULNR) at Screening
    • Subjects with a serum creatinine > ULNR (e.g. > 1.2 mg/dL for males and > 1.0 mg/dL for females) at Screening

    Other medical conditions
    • Subjects with diabetes mellitus type 1 or unstable type 2
    • History of solid-organ transplantation
    • History of cancer within the last 5 years treated with anti-cancer chemotherapy
    • Current active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to Baseline. Opiate-containing medicines are not allowed
    • Evidence of any significant and/or unstable concomitant diseases such as nervous system, renal, hepatic, endocrine, respiratory or gastrointestinal disorders which, in the Investigator’s opinion, would preclude subject participation
    • Any other medical condition (e.g. clinically relevant abnormal laboratory values) that would, in the Investigator's opinion, make the administration of trial drug or trial procedures hazardous to the subject, or obscure the interpretation of AEs.

    Skin
    • Chronic skin ulcerations.

    Previous and concomitant therapies and procedures
    • Any planned, elective or emergency surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to or planned within 52 weeks after Baseline
    • Treatment with any investigational agent 12 weeks or five half-lives of the investigational drug or the duration of that agent’s PD effect (whichever is longer) prior to Baseline
    • Previous treatment with any cell-depleting therapies, including investigational agents
    • Persistent urinary catheter or regular intermittent catheterisation

    Other
    • Previous participation in this clinical trial
    • Pregnancy
    • Donation or loss of more than 400 mL of blood within less than 3 months before first IMP administration
    • History of MTX toxicity (especially pulmonary, hepatic or haematologic toxicity) and unable to tolerate a stable dose of at least 12.5 mg/week
    • Lack of peripheral venous access
    • Employee at the investigational site, relatives or spouse of site staff
    • Suspected inability, e.g. language problems, or unwillingness to comply with trial procedures
    • Subjects enrolled in this trial will not be allowed to donate blood, germ cells, organs, or bone marrow during the trial and for at least 12 months after the last administration of the IMP
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the ACR20 responder rate after 24 weeks of double blind treatment with the study medication. Responders will be defined as those whose improvement from baseline to endpoint fullfil the following criteria:
    • more or equal to 20% reduction in the TJC (66/68)
    • more or equal to 20% reduction in the SJC (66/68)
    • more or equal to 20% reduction in three of the following additional measures:
    - Subject assessment of pain (visual analogue scale [VAS])
    - Subject global assessment of disease activity (VAS)
    - Physician global assessment of disease activity (VAS)
    - Degree of disability (HAQ-DI)
    - Level of acute-phase reactant (CRP)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last patient last visit (after 48 weeks)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 300
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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