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    Summary
    EudraCT Number:2010-020839-39
    Sponsor's Protocol Code Number:RA0056
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-020839-39
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITH
    AN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with
    an unsuccessful response to anti-TNF therapy
    A.3.2Name or abbreviated title of the trial where available
    RA0056
    A.4.1Sponsor's protocol code numberRA0056
    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 SponsorUCB Biosciences, Inc. A Member of the UCB Group of Companies
    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 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 nameCDP6038
    D.3.2Product code CDP6038
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.1CAS number 1007223-17-7
    D.3.9.2Current sponsor codeCDP6038
    D.3.9.3Other descriptive nameRecombinant human Mab of IgG4 subtype
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 RoActemra 20 mg/ml concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameTocilizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRoActemra®
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeEU/1/08/492/001-6
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    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
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of CDP6038 administered sc at various doses and dose administration frequencies relative to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the safety of CDP6038 at various doses and dose administration frequencies relative to placebo
    • To assess the PK and immunogenicity of repeated doses of CDP6038
    • To assess the dose- and exposure-response relationships of CDP6038 with efficacy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, all of the following criteria must be met:
    1. Subject must be able to understand the information provided to them, be given ample time and opportunity to ask questions and to decide whether or not to participate, and provide written informed consent. The subject should also be able to communicate satisfactorily with the Investigator and be willing to participate in the study and to comply with all study requirements.
    2. Subject must be at least 18 years old at Screening.
    3. Subject must have a diagnosis of adult-onset RA of at least 6 months’ (24 weeks)
    duration as defined by the 1987 ACR classification criteria (Arnett et al, 1988) or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA (Aletaha et al, 2010).
    4. Subject must have moderately to severely active RA disease as defined by each of the following:
    ◦ ≥6 tender joints (68-joint count) at Screening and Baseline
    ◦ ≥6 swollen joints (66-joint count) at Screening and Baseline
    ◦ CRP ≥1.2 times the upper limit of normal (ULN) (central laboratory) or ESR
    >28mm/hour (Westergren)
    5. Subject must be on a dose of MTX between 15 to 25mg/week, which has been stable for at least 6 weeks prior to Screening with a stable route of administration. Subjects may be dosed with 10 to less than 15mg weekly if they have documented reasons of toxicity.
    6. Subject must have had intolerance or inadequate response to treatment (ie, TNF-blocker failure) with 1 or more licensed TNF-blocker therapies (etanercept, infliximab,
    golimumab, certolizumab pegol, or adalimumab) within 2 years of Screening.
    7. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study. Female subjects of childbearing potential must agree to use adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038.
    E.4Principal exclusion criteria
    Rheumatoid arthritis disease-related and other treatment-related exclusions:
    1. Subjects who have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis, ankylosing spondylitis, or gout, or lupus).
    2. Subjects who have a secondary, noninflammatory type of arthritis (eg, osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of IMP on the subject’s primary diagnosis of RA.
    3. Subject who is Steinbrocker IV functional capacity.
    4. Subjects must be free of the prohibited medications (as detailed in section 6.2 of the study protocol)
    5. Subjects must be free of biological therapy (as detailed in section 6.2 of the study protocol)
    6. Participation in any other clinical drug or device study (including a biologic product)
    within 12 weeks or 5 half-lives, or within protocol-specified durations for specific agents, whichever is longer, prior to Baseline.
    Medical history-related exclusions:
    7. Subject has a creatinine level, an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level, platelets or a white blood cell count, or a neutrophil count at Screening in accordance with the protocol parameters (refer to protocol).
    8. Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks following last dose of IMP.
    9. Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    10. Subject with a history of chronic or recurrent infections (refer to protocol).
    11. Subjects with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
    12. Subjects at high risk of infection (eg, presence of leg ulcers or an indwelling urinary catheter, bedridden, or wheelchair-bound subjects).
    13. Subjects with known concurrent acute or chronic viral hepatitis B or C infection.
    14. Subjects with known human immunodeficiency virus (HIV) infection.
    15. Subject has known TB disease, high risk of acquiring TB infection, or latent TB infection (refer to protocol).
    16. Subjects that have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted).
    17. Concurrent malignancy or a history of malignancy (refer to protocol).
    18. Subjects with a history of a lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
    19. Subjects with a history or presence of cardiovascular, respiratory, hepatic, renal,
    gastrointestinal, endocrinological, dermatological, neurological, psychiatric,
    hematological (including bleeding disorder), or immunologic/immunodeficiency
    disorder(s) which are clinically significant enough in the opinion of the Investigator or
    Sponsor to alter the absorption and disposition of IMP, or constitute a possible
    confounding factor for assessment of efficacy or safety of the IMP.
    20. Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac (including Class IV congestive heart failure according to the New York Heart Association 1964 classification criteria [Criteria Committee of the New York Heart Association, 1964], neurological (including cerebral disease).
    21. Subjects with planned surgery during the study.
    22. Subject with a history of chronic alcohol abuse within the last 1 year.
    23. Subject with a history of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
    24. Subject has a known hypersensitivity to any components of the IMP or comparative drugs as stated in this protocol.
    25. Subject is legally institutionalized.
    26. Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
    27. Subjects with any other condition (eg, clinically significant laboratory values besides those prespecified in Exclusion Criterion 7) which in the Investigator’s or Sponsor’s judgment would make the subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy variables
    The primary efficacy variable is the change from Baseline in the DAS28(CRP) at Week 12 for CDP6038 and placebo.

    Primary pharmacokinetic/pharmacodynamic variables
    Assuming a 2-compartment PK model (consistent with prior knowledge), the primary PK variables are:
    • Absorption rate constant (Ka)
    • Apparent clearance
    • Apparent volumes of distribution of the central and peripheral compartments, V1/F and V2/F (or V2/F and V3/F if Compartment 1 is defined as the depot compartment)
    • Intercompartment clearance (Q) Individual concentrations at the time of clinical observations (Ci) will be derived from the PK model. It will be used as the exposure measurement to assess the exposure-response relationship. The PK/PD models for dose- and exposure-response will be described by the following primary PD variables:
    • Dose leading to 50% of the maximum effect (D50) on DAS28(CRP)
    • Exposure leading to 50% of the maximum effect on DAS28(CRP)
    • Concentration leading to 50% of the maximum effect (EC50) on DAS28(CRP)
    • Slope of effect (γ) on DAS28(CRP)
    In addition, anti-CDP6038 antibodies and the concentration of TCZ following repeated doses will be assessed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy variables
    The primary efficacy variable is the change from Baseline in the
    DAS28(CRP) at Week 12 for CDP6038 and placebo.
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Double-blind, placebo and active-controlled, factorial design, randomized study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    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
    The end of the study is defined in the protocol in section "5.1.1 Study duration per 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.2.1Number of subjects for this age range: 220
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 220
    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)
    Subjects who complete the study will be eligible to receive CDP6038 in the open-label extension study, RA0057, until the approval of the marketing application for the indication of RA in the subject’s country or region or until further notice from UCB. A follow up on all adverse events as described in the protocol section 12, Assessment of Safety, will also be performed.
    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 Decision2010-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-29
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