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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2008-005427-28
    Sponsor's Protocol Code Number:C87094
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005427-28
    A.3Full title of the trial
    Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis).
    A.3.2Name or abbreviated title of the trial where available
    Realistic
    A.4.1Sponsor's protocol code numberC87094
    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 Pharma SA
    B.1.3.4CountryBelgium
    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 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 typeequal
    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 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 typePEGylated antibody Fab' fragment
    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
    Artritis reumatoide (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 assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.
    E.2.2Secondary objectives of the trial
    ? To assess:
    - for all patients at Week 12, and every 8 weeks and at the completion/withdrawal visit in the group remaining in the study after Week 12:
    - clinical response rate.
    - reduction of disease activity.
    - achievement of clinical remission.
    - additionally, at Week 12:
    - improvement in individual components of the ACR criteria
    - Time to sustained ACR20 response.
    - European League Against Rheumatism (EULAR) response.
    - additionally, every 8 weeks and at completion/withdrawal visit :
    - change from Baseline in individual components of the ACR criteria.

    ? Tolerability and safety of CZP therapy over the first 12 weeks of treatment and over the open-label treatment extension period.

    ? To evaluate the influence of some characteristics (as per protocol) on ACR20 response rate at Week 12 and adverse events rate with CZP therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be at least 18 years old at the screening visit.
    2. Patients must be able to understand the information provided to them and to give written Informed Consent.
    3. Female patients must be either postmenopausal for at least one 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 only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after their last dose of CZP. Male patients must agree to ensure they or their female partner(s) uses adequate contraception during the study and for 12 weeks after the patient receives their last dose of CZP.
    4. Patients must have a diagnosis of adult?onset RA of at least three months duration as defined by the 1987 American College of Rheumatology classification criteria.
    5. Patients must have active RA disease as defined by:
    ? ?5 tender joints (28 joint count) at Screening and Baseline; and
    ? ?4 swollen joints (28 joint count) at Screening and Baseline; and
    ? ?10 mg/L CRP and/or ?28mm/hour ESR (Westergren)
    6. Patients must have had an unsatisfactory response or intolerance to at least one traditional DMARD
    7. Patients must be able and willing to comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    1. Patients have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
    2. Patients have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity.
    3. Patients have a secondary, non?inflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigator?s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient?s primary diagnosis of RA.
    4. Patients have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    5. Patients have received any of prohibited medication as detailed in the protocol.
    6. Patients have received any experimental non?biological therapy, within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline visit (whichever is longer).
    7. Patients have received any experimental biological agent within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline (whichever is longer).
    8. Patients have received any biological therapy for RA within two months prior to Baseline visit, except for etanercept or anakinra for which a one month washout prior to baseline visit is acceptable.
    9. Patients having discontinued or discontinuing biological therapy for their RA have had a severe hypersensitivity reaction or an anaphylactic reaction to more than 1 different biologic agent.
    10. Patients have received treatment with more than 2 anti-TNF agents prior to enrollment in this study.
    11. Patients have received treatment with rituximab and/or abatacept.
    12. Female patients who are breast-feeding, pregnant, or plan to become pregnant during the study or within twelve weeks following last dose of study drug.
    13. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life?threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
    14. Patients with active TB (or history of active TB), positive chest X?ray for TB, or positive (defined as induration of ? 5mm) PPD skin test or patients having close contact with an individual with active TB. Patients having a PPD skin test ? 5 mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent TB (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of CZP.
    15. Patients at a high risk of infection (e.g., leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).
    16. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
    17. Patients with concurrent acute or chronic viral hepatitis B or C.
    18. Patients with known human immunodeficiency virus (HIV) infection.
    19. Patients receiving any vaccination (live or attenuated) within eight weeks prior to baseline (e.g., parenteral influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not).
    20. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening).
    21. Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.
    22. Patients with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.
    23. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
    24. Patients with a history of an adverse reaction to PEG.
    25. Patients with any other condition (e.g., clinically significant 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)
    The primary efficacy variable is the ACR 20 (American College of Rheumatology 20% response criteria) responder rate at Week 12.

    Safety variables to be assessed are adverse events, vital signs, physical examination (including symptoms of active tuberculosis), and measurements of laboratory parameters.

    Clinical laboratory values (hematology, serum biochemistry, and urinalysis) will be collected and assessed.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    the second part of the trial design is open-label
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 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 study is defined as the date of Last Patient Last Visit, which is the safety follow-up visit occuring 12 weeks post-last dose intake (after the last country receives marketing approval or further notification from UCB).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1048
    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 11.2.14 and 11.2.15 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 Decision2009-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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