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    Summary
    EudraCT Number:2010-022224-77
    Sponsor's Protocol Code Number:RA0057 Protocol Amendment 2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-14
    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 number2010-022224-77
    A.3Full title of the trial
    A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label study to assess the safety and efficacy of CDP6038 in
    patients who completed RA0056
    A.3.2Name or abbreviated title of the trial where available
    RA0057
    A.4.1Sponsor's protocol code numberRA0057 Protocol Amendment 2
    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 SponsorUCB Biosciences, Inc.
    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.3.8INN - Proposed INNOlokizumab
    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.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
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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 assess the long-term safety of CDP6038 dosed at 120mg q2w while treating the signs and symptoms of active RA in subjects who have previously failed TNF╬▒ blocker therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the long-term efficacy of CDP6038, its plasma levels, and immunogenic profile.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects completing RA0056 are eligible to participate in this study, if all of the following criteria are met:
    1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
    written Informed Consent form is signed and dated by the subject.
    2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
    3. Subject completed the RA0056 study (Week 12 Visit).
    4. Subject must have maintained their stable dose (and route) of MTX between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks. Subjects may have been dosed with 10 to ≤12.5mg weekly if they have documented reasons for toxicity.
    5. 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 2 methods of 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
    Subjects are not permitted to enroll in the study if any of the following criteria is met:
    1. Subject has an ongoing SAE from the RA0056 study.
    2. Female subject of childbearing potential has a positive pregnancy test at Week 12 in RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of IMP.
    3. Subject has evidence of active or latent tuberculosis (TB).
    4. Subject is receiving any biologic response modifier or synthetic DMARD other than
    MTX.
    5. Subject has an alcohol consumption of more than 1 unit per day. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL).
    6. Subject has planned surgery during the first 12 weeks of the study.
    7. Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent AEs or SAEs, or infection SAEs) 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)
    Safety variables
    • AEs
    • Vital signs
    • Chest x-rays
    • Electrocardiograms (ECG)
    • Laboratory parameters

    Pharmacokinetic variables
    • PK of CDP6038 following repeat dose administration
    • Anti-CDP6038 antibodies

    Efficacy variables
    • Change from Baseline (Week 0 of RA0056) in the DAS28(CRP) at Weeks 12, 24, 48, and 96
    • ACR20/50/70 improvement criteria response rates (from Baseline at Week 0 of RA0056) at Weeks 24, 48, and 96
    • Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) ≤3.2 at Weeks 12, 24, 48, and 96
    • Change from Baseline (Week 0 of RA0056) in CDAI and SDAI at Weeks 48, and 96

    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs – assessed every 2 weeks throughout the study
    Vital signs – assessed every 2 weeks throughout the study
    Chest x-rays – assessed at Week 48 and completion
    Electrocardiograms (ECG) – assessed at Weeks 4, 12, 24, 48 and
    completion
    Laboratory parameters – assessed at Weeks 2, 4, 8, 12, 16, 24, 32, 40,
    48 and q8w thereafter to study completion
    E.5.2Secondary end point(s)
    Efficacy variables include:
    Change from Baseline (Week 0 of RA0056) in the DAS28(CRP)
    ACR20/50/70 improvement criteria response rates (from Baseline at
    Week 0 of RA0056) Percentage of subjects with DAS28(CRP) <2.6 and
    with DAS28(CRP) ≤3.2
    Change from Baseline (Week 0 of RA0056) in CDAI and SDAI PK and
    antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy variables include:
    Change from Baseline (Week 0 of RA0056) in the DAS28(CRP) at Weeks
    12, 24, and 48
    ACR20/50/70 improvement criteria response rates (from Baseline at
    Week 0 of RA0056) at Weeks 24, and 48
    Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) ≤
    3.2 at Weeks 12, 24, and 48
    Change from Baseline (Week 0 of RA0056) in CDAI and SDAI at Week 48
    PK and antibodies:
    Weeks 4, 8, 12, 16, 24, 32, 48, and 72
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open Label Follow-Up Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 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
    Belgium
    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 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 months6
    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 months6
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 190
    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)
    Eligible subjects will enter the study after completing the Week 12 Visit of RA0056 and will be allowed to continue in this open-label study for a period of 5 years, or until further notice from UCB.
    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 Decision2011-02-03
    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 StatusPrematurely Ended
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