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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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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    EudraCT Number:2005-002326-63
    Sponsor's Protocol Code Number:CDP870-050
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2005-002326-63
    A.3Full title of the trial
    A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.
    A.4.1Sponsor's protocol code numberCDP870-050
    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.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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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. 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
    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 compare the efficacy of two dose regimens of liquid formulation certolizumab pegol in combination with MTX to MTX alone in treating the signs and symptoms of patients with active rheumatoid arthritis.
    E.2.2Secondary objectives of the trial
    To assess two dose regimens of certolizumab pegol in combination with MTX and MTX alone in:

    The safety and tolerability of certolizumab pegol in patients with active RA.

    The prevention of joint damage in patients with active RA.

    Health Outcomes Measures in patients with active RA.

    Improving physical function in patients with active RA.

    To characterize the pharmacokinetic profile and immunogenicity of two dose regimens of liquid formulation certolizumab pegol in combination with methotrexate.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients must be at least 18 years old at the screening visit.

    2. Patients must have a clear chest X–ray within three months prior to the Baseline visit (negative for TB).

    3. Female patients of childbearing potential must have a negative serum pregnancy test at the screening visit and negative urine testing immediately before every certolizumab pegol administration. Females must be surgically sterile, postmenopausal for at least 2 years prior to screening visit, must have undergone tubal ligation or be using an acceptable method of birth control for the duration of the study and for 12 weeks after the last dose of certolizumab pegol. Oral contraceptives must be stable for at least 28 days prior to screening visit. Abstinence is not an acceptable method of contraception for the study.

    4. Patients must have a diagnosis of adult–onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.

    5. Patients must have active RA disease as defined by:
    ≥9 tender joints at Screening and Baseline.
    ≥9 swollen joints at Screening and Baseline.
    and fulfilling 1 of the following 2 criteria during the screening period:
    a) ≥30 mm/hour ESR (Westergren),
    b) CRP >15 mg/L.

    6. Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

    7. Patients must be willing to complete an X–ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

    8. Patients must be able to understand the information provided to them and to give written Informed Consent.
    E.4Principal exclusion criteria
    RA Disease–Related Exclusions:

    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, non–inflammatory type of arthritis (e.g. OA 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.

    3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. Concomitant medication exclusions

    4. Patients must be free of prohibited medication as detailed on page 33 & 34 of the protocol.

    Previous clinical trials and previous biological therapy exclusion:

    5. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit.

    6. Patients must not have received any biological therapy for RA within six months prior to Baseline visit, except for etanercept and anakinra where a three month washout prior to baseline visit is acceptable.

    7. Patients must not have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.

    8. Patients who failed to respond to previous treatment with an anti–TNF drug are excluded. Patients who initially responded to a previous treatment with an anti-TNF drug but who later discontinued that drug due to loss of efficacy or other reasons may be included.

    Medical History Exclusion:

    9. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.

    10. Patients with a history of chronic infection, recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.

    11. Patients with a history of tuberculosis or positive chest X–ray for tuberculosis or positive (defined as positive induration per local medical practice) PPD skin test. Patients with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator. Consideration should be given to the fact that a positive PPD skin test with prior vaccination does not exclude latent TB.

    12. 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 bed ridden or wheelchair bound).

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

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

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

    16. Patients receiving any vaccination (live or attenuated) within eight weeks prior to Baseline. (However, influenza and pneumococcal vaccines are allowed).

    17. 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).

    18. Patients with a history of blood dyscrasias.

    19. 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 diseasewhich would interfere with the patient’s participation in the trial.

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

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

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

    23. 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)
    Primary endpoint and analysis:

    The primary efficacy variable is the ACR20 responder rate at Week 24 (Visit 17). The study will be declared successful for the treatment of signs and symptoms objective if at least one of the two dose comparisons to placebo is statistically significant for the ACR20 endpoint.

    Treatment comparisons versus placebo for the two certolizumab pegol dose groups will be performed using logistic regression with factors for treatment and country. Statistical tests will be performed two–tailed at the 2.5% level of significance.
    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 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. 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 No
    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.8.5The 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 date of final Clinical Study Report. At this time, interactions between the Sponsor and the Investigator(s) with possible impact on subject’s data have ended.
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 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 2005-11-22. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 590
    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 who fail to achieve an ACR20 response at Week 12, and patients who complete the entire CDP870-050 study through Week 24 may be given the opportunity to enter an extension study to continue to assess the efficacy and safety of liquid certolizumab pegol as additional medication to methotrexate. All patients in the trial are expected to have a final follow-up visit at 12 weeks post the last dose which would occur at week 34 for subjects completing the full 24 weeks of treatment.
    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 Decision2005-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-09-19
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