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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   41232   clinical trials with a EudraCT protocol, of which   6757   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:2012-003876-38
    Sponsor's Protocol Code Number:GP13-302
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-003876-38
    A.3Full title of the trial
    A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past
    A.3.2Name or abbreviated title of the trial where available
    ASSIST-RT
    A.4.1Sponsor's protocol code numberGP13-302
    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 SponsorHexal AG (a Sandoz company)
    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 supportHexal AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHexal AG (a Sandoz company)
    B.5.2Functional name of contact pointDmitrij Kollins
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestr. 25
    B.5.3.2Town/ cityHolzkirchen
    B.5.3.3Post code83607
    B.5.3.4CountryGermany
    B.5.4Telephone number+4980244764718
    B.5.5Fax number+4980244764870
    B.5.6E-maildmitrij.kollins@sandoz.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 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 nameGP2013
    D.3.2Product code GP2013
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeGP2013
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleComparator
    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 MabThera®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMabThera®
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes
    inflammation and deformity of the joints. Other problems may also
    develop, including inflammation in various parts of the body.
    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 19.1
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective is to identify potential safety risk of the transition from the originator product (US-licensed Rituxan® or EU-approved MabThera®) to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
    E.2.2Secondary objectives of the trial
    Is no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant, non-lactating female patients at least 18 years of age at screening, who give written informed consent before any assessment is performed.
    2. Patients must have the diagnosis of RA (according to American College of Rheumatology 2010 criteria).
    3. Patients must have received at least one full treatment course of rituximab for the therapy of RA (i.e. 2 complete i. v. infusions of 1000 mg of Rituxan® in the USA or MabThera® in the EU) six to eighteen months prior to randomization.
    4. Patients must be eligible for the subsequent treatment course with Rituxan® or MabThera® according to the clinical judgment of the Investigator.
    5. Patients must be on a stable dose of methotrexate (MTX) (7.5 to 25 mg per week) for at least 4 weeks prior to randomization. If patients receive a combination of DMARDs (MTX + hydroxychloroquine or MTX+ chloroquine or MTX+ sulfasalazine) these DMARDs must be also on a stable dose for at least 4 weeks prior to randomization.
    6. Patients must be on a stable dose of folic acid or folinic acid (≥ 5 mg per week) for at least 4 weeks prior to randomization.
    E.4Principal exclusion criteria
    1. RA of functional status class IV classified according to the ACR 1991 revised criteria.
    2. Systemic manifestation of RA, with the exception of Sjögren’s syndrome.
    3. Use of any other investigational drugs within 30 days prior to screening (or within 5 half-lives or until the expected PD effect has returned to baseline, whichever is longer).
    4. Requiring treatment with any biological medicinal product during the study other than the study medication.
    5. Treatment with any biologics for any indication since the start of last treatment with either Rituxan®/MabThera®.
    6. History of severe hypersensitivity to either Rituxan®/MabThera® or any of its excipients, requiring drug discontinuation.
    7. Any contraindication to Rituxan®/MabThera® or MTX.
    8. Therapy with any DMARDs (including tofacitinib) other than MTX or combination of MTX with hydroxychloroquine or MTX with chloroquine or MTX with sulfasalazine within 4 weeks prior to randomization. In case of leflunomide it has to be discontinued 8 weeks prior to randomization (if a cholestyramine washout is performed, leflunomide has to be discontinued 4 weeks prior to randomization).
    9. Previous treatment with any cell depleting therapies, including investigational agents.
    10. Current treatment or need for treatment with any prohibited medications.
    11. Any serious illness or uncontrolled medical condition, including but not limited to severe infections, significant hepatic or renal disease, uncontrolled hypertension (defined as ≥160/95), congestive heart failure (NYHA class III or IV), or other severe, uncontrolled cardiac disease.
    12. Any medical condition which, in the investigator’s opinion, would preclude the patient from completing all protocol requirements.
    13. Any of the following laboratory values at screening: WBC < 3000/μL; Platelets < 100.000/μL; Neutrophils < 1.500/μL; Hemoglobin < 85 g/L; aspartate aminotransferase (AST) > 3 × ULN (upper limit of normal); alanine aminotransferase (ALT) > 3 × ULN; gamma-glutamyl transferase (GGT) > 3 × ULN; alkaline phosphatase (AP) > 3 × ULN; glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (GFR calculated as per 4-variable MDRD formula); immunoglobulin G (IgG) and/or IgM and/or IgA below LLN.
    14. Positive serology to hepatitis C infection.
    15. Positive serology to hepatitis B infection.
    15a. In case a patient is HBsAg negative but positive for hepatitis B core antibody [anti-HBc], this patient can only be included after consultation with a hepatitis expert to clarify the potential risk of Hepatitis B reactivation, required Hepatitis B monitoring and antiviral therapy.
    16. History of serious recurrent or chronic infectious disease (excluding fungal infections of the nail beds) or active systemic infection within 2 weeks prior to screening or during the screening period, except for common cold.
    17. Severely immunocompromised state, including but not limited to Felty’s syndrome and known (HIV) infection.
    18. Any malignancy prior to screening, with exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer, or non-invasive malign colon polyps that have been removed with no evidence of recurrence.
    19. Active tuberculosis. If a QuantiFERON®- Tuberculosis (TB) Gold test at screening is positive, further work-up, according to local guidelines/practices needs to be performed to conclusively establish that that the patient has no evidence of active tuberculosis.
    20. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test (> 5 mIU/mL).
    21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree to use highly effective methods of contraception during the study and up to 12 months after last infusion of study medication. Women are considered not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    22. History of vaccination with live vaccines within 4 weeks prior to randomization or known to require live vaccines during the 6 month after the randomization visit.
    23. History or evidence of ongoing drug or alcohol abuse within the last 6 months.
    24. Blood donation or blood loss of >400 mL in the 8 weeks prior to randomization.
    25. Inability or unwillingness to undergo repeated venipuncture (poor tolerability or lack of access to veins).
    E.5 End points
    E.5.1Primary end point(s)
    The following safety variables will be evaluated:
    • Hypersensitivity reactions
    • Anaphylactic reactions
    • Infusion-related reactions
    • Immunogenicity (development of anti-drug-antibodies (ADA))
    • Adverse events and serious adverse events
    • Other safety variables (vital signs, laboratory variables, body weight)
    E.5.1.1Timepoint(s) of evaluation of this end point
    All safety parameters will be analyzed on the safety analysis set (SAF).
    E.5.2Secondary end point(s)
    Is no secondary end points
    E.5.2.1Timepoint(s) of evaluation of this end point
    Is no secondary end points
    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 No
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Germany
    Hungary
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 Visit Last Subject
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 80
    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 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    Standard of Care
    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 Decision2015-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-12
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