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    Summary
    EudraCT Number:2009-010813-57
    Sponsor's Protocol Code Number:RA0010
    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:2009-06-24
    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 number2009-010813-57
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate.
    A.4.1Sponsor's protocol code numberRA0010
    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 Celltech
    B.1.3.4CountryUnited Kingdom
    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 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.3.9.1CAS 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) 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) No
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    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 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 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.3.9.1CAS 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) 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) No
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    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
    D.8 Placebo: 2
    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 placeboIntravenous 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 9.1
    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 characterize the PK/PD relationship between systemic CDP6038 exposure and CRP suppression, following single dose CDP6038 administration via iv infusion and sc injection to subjects with RA.
    • To evaluate the safety and tolerability of single doses of CDP6038 in RA subjects over a therapeutic dose range (as defined by CRP suppression).
    E.2.2Secondary objectives of the trial
    • To determine the absolute bioavailability of CDP6038 given via sc administration in comparison with iv infusion in subjects with RA.
    • To assess the immunogenicity of single dose CDP6038 in subjects with RA.
    • To assess, on an exploratory basis, changes in clinical response and other systemic biomarkers with CDP6038 dosing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has been informed and given ample time and opportunity to ask questions and to decide whether or not to participate and has provided written informed consent. The subject should also be able to communicate satisfactorily with the Investigator to participate in the study and to comply with all study requirements.
    2. Subject is aged between 18 and 75 years (inclusive).
    3. Subject has a diagnosis of RA (diagnosed according to ACR criteria) of more than 6 months’ duration and has been on a stable MTX dose of 5 to 25mg/week for at least 3 months prior to Screening.
    4. Subject has ≤9 swollen and ≤9 tender joints (28-joint count) or a DAS28(CRP) of ≤5.10.
    5. Subject has a minimum Screening CRP of 0.05mg/dL.
    6. Confirmation that female subjects of child-bearing potential (ie, not surgically sterile by hysterectomy/bilateral oophorectomy or bilateral tubal ligation or postmenopausal for at least 2 years prior to Screening), use a contraceptive method over the entire exposure period and that a male partner use barrier contraception (eg, a condom). Abstinence is not considered an acceptable method of contraception.
    7. Confirmation that the male subject, when having sexual intercourse with women of childbearing potential (ie, not surgically sterilized and not at least 2 years postmenopausal), will use a contraceptive barrier (eg, condom) over the entire exposure period and that the respective partner will use an additional contraceptive method. Abstinence is not considered an acceptable method of contraception.
    8. Subject has a body mass index (BMI) between 19.0 and 38.0kg/m² (inclusive).
    9. Subject has an ECG with interpretations considered as “normal” or as “abnormal” but within the agreed upon clinically nonsignificant ranges predefined by the Sponsor in the ECG manual.
    10. Subject has results of clinical safety laboratory tests, including liver function tests, within the laboratory reference ranges or outside the laboratory reference range but within limits predefined by the Sponsor in the laboratory manual and deemed acceptable and not clinically relevant by the Investigator.
    11. The subject is considered to be reliable and capable of adhering to the protocol, according to the judgment of the Investigator.
    E.4Principal exclusion criteria
    1. Participation in any other clinical drug or device study (including a biologic product) as per protocol.
    2. Subjects who have received prior treatment with: a) etanercept or anakinra within 4 weeks prior to screening, b) golimumab, infliximab, adalimumab, certolizumab pegol or abatacept within 3 months prior to screening, c) B-cell depleting therapy within 6 months prior to screening or B-cell depleting therapy ≥6 months prior to screening but who have CD19 counts ≤75 (cells/µL), d) any other experimental biologics within 3 months or 5 half-lives, which ever is longer, prior to screening, and e) tocilizumab or other anti-IL-6 preparations.
    3. Subject is not willing to abstain from participating in any other study until the last study visit.
    4. Presence of any medical condition (except for RA disease), including any form of primary immunodeficiency, leading to a deficiency in either adaptive or innate immune response.
    5. Subject has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological or immunologic disorder(s) which are clinically significant enough in the opinion of the Investigator to alter the absorption and disposition of drugs, or constitute a risk factor when taking the study medication.
    6. Subject taking any medication for management of their RA disease, apart from MTX and those stated in Section 7.8.1.
    7. Subject with a present condition of malignancy or history of malignancy as per protocol.
    8. Subject with a history of prosthetic joint infection with the same prosthesis still in situ.
    9. Subject with a known clinically relevant allergy or known severe adverse reaction to any drug, hypersensitivity to protein made from bacterial yeast or mammalian producer cells, or known or suspected clinically relevant drug hypersensitivity.
    10. Female subjects who are pregnant or lactating.
    11. Subject with a known, clinically significant history of any chronic latent, persistent, opportunistic, or severe bacterial, viral, systemic fungal, or parasitic infection within the 2 years prior to Screening, or any clinically significant recent (within the last 6 months prior to Screening) bacterial, viral, systemic fungal, parasitic infection, or any current sign or symptom that may indicate an infection.
    12. Subjects with infections requiring more than 2 courses of antibiotics within the last 6 months prior to Screening.
    13. Subject with a positive TIGRA (T-cell interferon-γ release assay) and/or positive skin test (purified protein derivative [PPD] or positive TIGRA only, in case of contraindication to PPD skin testing, for tuberculosis and/or a chest x–ray showing evidence of possible latent/active tuberculosis.
    14. Subject with evidence from chest x-ray of interstitial lung disease. Subjects with other abnormalities on chest x-ray which, in the opinion of the Investigator would prevent appropriate evaluation of the subject.
    15. Subject with a positive test to Human Immunodeficiency Virus-1/2 antibody (HIV 1/2Ab).
    16. Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive.
    17. Subject with a history of chronic alcohol abuse within the last 2 years, or a positive alcohol test at Screening and/or Day-1. Subjects should restrict their alcohol consumption to no more than 1 unit per week.
    18. Subject with a history of drug addiction within the last 2 years or current drug addiction or use.
    19. Subject with uncontrolled hypertension - systolic blood pressure (SBP) >150mmHg or diastolic blood pressure (DBP) >95mmHg.
    20. Subject with orthostatic hypotension, defined as per protocol.
    Blood pressure should be taken as per protocol.
    21. Subject has any psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
    22. Subjects with any other condition which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.
    23. Vulnerable and legally detained individuals.
    24. 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.
    25. Subjects with planned surgery during the Study Period.
    26. Subjects that have received vaccinations within 8 weeks prior to Day -1 or plan to receive vaccines during the Study Period (with the exception of injectable influenza and pneumococcal vaccinations).
    E.5 End points
    E.5.1Primary end point(s)
    • Pharmacodynamic variable: serum concentration of CRP by using a hsCRP assay.

    • Pharmacokinetic variables: Cmax, CL, Vd, AUC0-inf, tmax, and t1/2 of CDP6038 in plasma.
    Anti-CDP6038 antibodies will also be measured.

    • Exploratory systemic biomarkers:
    1. Exploratory biomarkers of
    1.1. bone turnover: bone degradation - serum carboxy-terminal crosslinked telopeptide of type I collagen (CTX-I) and bone synthesis - amino-terminal propeptide of type I procollagen (PINP)
    1.2. cartilage turnover: cartilage synthesis - serum amino-terminal propeptide of type IIA procollagen (PIIANP) and cartilage degradation - urinary carboxy-terminal crosslinked telopeptide of type II collagen (CTX-II)
    1.3. synovial abnormality: synovial inflammation - matrix metalloproteinase 3 (MMP3) and angiogenesis in pannus - vascular endothelial growth factor (VEGF)
    2. SAA and fibrinogen
    3. IL-6, sIL-6R, and sgp130
    4. RF and anti-CCP antibodies
    5. Anti-IL-6 autoantibodies (included as part of the PK assay) and ANA

    • Clinical variables:
    Change in DAS28 will be used to assess clinical activity.

    • Safety Variables:
    1. AEs and SAEs
    2. Vital signs (including BP, HR, respiratory rate, and temperature)
    3. ECG monitoring
    4. Clinical laboratory tests as per protocol: hematology, coagulation, clinical chemistry, serology, urinalysis, drug screening, tuberculosis test, alcohol test
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    bioavailability and dose/exposure response
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Human pharmacology study in RA patients
    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
    Study with 2 cohorts of subjects. The allocation to dose route (iv or sc) will be open.
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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 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 as the date of the last visit of the last subject in the study.
    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.1.3Elderly (>=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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 72
    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)
    Please refer to sections 8.14 to 8.16 in protocol.
    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 Decision2009-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-20
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