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    Summary
    EudraCT Number:2005-002629-30
    Sponsor's Protocol Code Number:CDP870-051
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-23
    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 ConcernedEstonia - SAM
    A.2EudraCT number2005-002629-30
    A.3Full title of the trial
    A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050.
    A.3.2Name or abbreviated title of the trial where available
    Follow on study to CDP870-050
    A.4.1Sponsor's protocol code numberCDP870-051
    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 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 Information not present in EudraCT
    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 nameCertolizumab pegol
    D.3.2Product code CDP870
    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 INNCertolizumab pegol
    D.3.9.2Current sponsor codeCDP870
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typePEGylated antibody Fab' fragment
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10039073
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To continue to assess the safety of the liquid formulation of certolizumab pegol, dosed at 400 mg sc every two weeks and 200 mg sc every two weeks, in treating signs and symptoms and preventing joint damage in patients with active rheumatoid arthritis (RA).
    E.2.2Secondary objectives of the trial
    1. To continue to assess the tolerability of liquid certolizumab pegol every two weeks in patients with active RA.

    2. To continue to assess the efficacy of liquid certolizumab pegol every two weeks in patients with active RA.

    3. To continue to assess the effect of liquid certolizumab pegol every two weeks on physical function in patients with active RA.

    4. To continue to assess the effect of liquid certolizumab pegol every two weeks on Health Outcome Measures in patients with active RA.

    5. To continue to monitor the pharmacokinetic and immunogenicity profile of liquid certolizumab pegol every two weeks in patients with active RA.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients must have either failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in the CDP870-050 trial or must have completed the entire CDP870-050 trial through Week 24.

    2. Patients must have complied with the protocol requirements during their participation in trial CDP870-050.

    3. Patients entering CDP870-051 who have completed the CDP870-050 trial must have a clear chest X-ray at the Entry visit (Week 24 Completion of CDP870-050). Patients who enter CDP870-051 at Week 16 of the CDP870-050 trial are not required to have a chest X-ray prior to enrollment.

    4. Female patients of childbearing potential must have a negative urine pregnancy test at the Entry visit and must continue to have negative urine pregnancy tests administered immediately before every certolizumab pegol administration. Females must be either surgically sterile, be postmenopausal for at least 2 years prior
    to screening visit, have undergone tubal ligation, or be using an acceptable method of birth control for the duration of the study and continuing for 12 weeks after the last dose of study drug (or longer if required by local regulations). Oral contraceptives must be stable for at least 28 days prior to Entry visit. Abstinence is not an acceptable method of contraception for the study.

    5. Patients must continue treatment on methotrexate with or without folic acid throughout the study, unless given prior approval by UCB for discontinuation.

    6. Patients must be able to understand the information provided to them and give written Informed Consent for CDP870-051.
    E.4Principal exclusion criteria
    RA Disease Related Exclusion
    1. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).

    2. Patients must not have a secondary condition, (e.g. OA or fibromyalgia) that, in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of liquid certolizumab pegol on the patient’s primary diagnosis of RA.

    3. Patients must not have a history of an infected joint prosthesis at any time if prosthesis still in situ.

    Concomitant Medication Exclusion
    4. At study entry patients must not be taking any of the prohibited medications as detailed in the CDP870-050 trial.

    Medical History Exclusion
    5. Female patients who are breast feeding, pregnant, or plan to become pregnant during the study and for 12 weeks following the last dose of study drug.

    6. Patients with a history of chronic infection, recent serious or life-threatening infection during CDP870-050 participation (including herpes zoster), or any current (study entry assessment) sign or symptom that may indicate an infection.

    7. Patients at a high risk of infection in the Investigator’s opinion (e.g. patients with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and patients who are permanently bed ridden or wheelchair bound).

    8. Patients with a history of tuberculosis or positive chest X-ray for tuberculosis at the Entry visit.

    9. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.

    10. Patients with a known positive hepatitis B surface antigen test and/or hepatitis C antibody test result.

    11. Patients with known human immunodeficiency virus (HIV) infection.

    12. Patients receiving any vaccination (live or attenuated) during the CDP870-050 trial with the exception of Influenza or Pneumococcal vaccines.

    13. Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).

    14. Patients with a history of blood dyscrasias.

    15. Patients with a current or recent history, as determined by the investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient’s participation in the trial.

    16. Patients with class III or IV congestive heart failure New York Heart Association (NYHA) 1964.

    17. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).

    18. Patients with a history of an adverse reaction to PEG or protein medicinal product.

    19. Patients with any other condition (e.g., clinically significant abnormal laboratory values) which in the Investigator’s judgment would make the patient unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse Events
    Extent of Exposure
    Haematology
    Biochemistry
    Urinalysis
    Urine pregnancy testing
    Physical Examination
    Vital signs
    Body Mass
    Concomitant Medication
    Chest X-ray
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 study is defined as the last subject/last visit in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 450
    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)
    Patients will continue with the marketed drug or the most other suitable treatment available if the investigator believes this a better treatment option for that patient.
    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 Decision2006-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-09
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