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    Summary
    EudraCT Number:2010-021146-22
    Sponsor's Protocol Code Number:5339
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-021146-22
    A.3Full title of the trial
    Alemtuzumab and rheumatoid arthritis - an immunisation study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system
    A.3.2Name or abbreviated title of the trial where available
    Alemtuzumab and rheumatoid arthritis - an immunisation study
    A.4.1Sponsor's protocol code number5339
    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 SponsorThe Newcastle upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenzyme Corporation, a Sanofi company
    B.4.2CountryUnited Kingdom
    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.2.1.1.1Trade name Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome)
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlemtuzumab (already received by alemtuzumab cohort between 1991 and 1994)
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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
    An autoimmune disease that causes inflammation in the joints. The main symptoms are joint pain and swelling.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    To compare the ability to mount immune responses (to measure the function of the immune system) in patients who received alemtuzumab for rheumatoid arthritis between 1991 and 1994 and a matched control group with long-standing rheumatoid arthritis. The control group will be matched for disease duration (within 5 years of matched case), age (within 10 years of matched case) and gender.
    E.2.2Secondary objectives of the trial
    To update data regarding reconstitution of lymphocytes (white blood cell believed to contribute to Rheumatoid Arthritis), mortality and morbidity in the group of patients who received alemtuzumab between 1991 and 1994. To compare specific parameters of immune function in alemtuzumab patients and controls (lymphocyte subsets by flow cytometry; Circulating cytokine levels; Thymic function; Serum immunoglobulins and serum protein electrophoresis; Rheumatoid factor and anti-CCP levels). To collect information on current disease activity in alemtuzumab patients and controls (Swollen joint count; Tender joint count; Patient VAS; ESR/CRP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All study participants must be able and willing to provide informed consent prior to any study-specific procedures, including immunisation. NOTE: Alemtuzumab recipients who do not wish to take part in the study (i.e. attend Addenbrooke’s for study procedures as outlined in Protocol Section 13.1, including blood samples with/without vaccination), but who are happy for morbidity information only to be collected via a phone call or via GP records on one occasion only (as per screening/baseline visit) will indicate their intention in writing on the study “Expression of Interest” form. Alemtuzumab recipients (cases) • Received alemtuzumab in original Cambridge studies (1991-94) Matched controls • Rheumatoid arthritis according to 1987 ACR criteria • Disease duration within 5 years of matched case • Age within 10 years of matched case • Gender profile to match alemtuzumab recipients
    E.4Principal exclusion criteria
    Both groups • Contra-indications to vaccination (as per SmPCs – see protocol Appendices B-D) • Recent vaccination with study strain of flu vaccine • Vaccination with tetanus, diphtheria, polio or pneumococcus within past 5 years (contra-indication to the specific vaccine only) Controls only • Received rituximab within past 3 months • Treatment with any investigational agent within 12 weeks or 5 half-lives of the investigational drug NOTE: Eligible patients (control or alemtuzumab cohort) who have received vaccination with pneumococcus, tetanus, diphtheria, or polio within the past 5 years will not be excluded from the study, but will NOT be revaccinated with the specific vaccine as relevant, i.e. Revaxis and/or Pneumovax II. NOTE: Eligible patients (control or alemtuzumab cohort) who are also women of child-bearing potential will have pregnancy status checked by a serum pregnancy test at the screening visit. Women who are subsequently confirmed as pregnant or who are breast feeding will NOT be excluded from the study but will NOT receive any of the three vaccines at the screening/baseline visit. Results from the serum pregnancy test (where relevant) must be obtained prior to vaccination. For relevant female patients whose pregnancy test is negative, a separate baseline visit is needed for vaccination only (once pregnancy results are known). The separate baseline visit must be within 7 days of the screening visit; the date of vaccination (baseline) would then be Day 0.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable is serological response 4 weeks after immunisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 (+/- 48 hours) after immunisation
    E.5.2Secondary end point(s)
    In alemtuzumab cohort only: • Mortality data to be obtained via the Office for National Statistics. Death certificates will be requested for those patients who have died since last follow-up to confirm cause of death. The alemtuzumab cohort are already flagged via Office for National Statistics for flagging and tracing (with consent). • Morbidity data collected will relate specifically to infectious and malignant morbidity since last follow-up. In both patient groups: • Adverse event profile at 4 weeks after immunisation. • Full blood count and lymphocyte subsets • Serum protein electrophoresis and immunoglobulin levels • T-cell receptor excision circles (measurement of thymic activity) • Serum cytokines (at minimum IL7, IL15, IL21) • Autoantibody levels • Disease activity score using 28 joints (DAS28) – Swollen joint count, Tender joint count, Patient VAS, ESR, CRP (Protocol Appendix E). • ACR Core Criteria, including Patient Health Assessment Questionnaire and Patient pain VAS (Protocol Appendix F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    In alemtuzumab cohort only: • Mortality data - as and when received by ONS. • Morbidity data - collected at combined screening/baseline visit only(or on one occassion only, via phone call to patient or via GP records, if pt does not wish to take part in study but happy for morbidity information to be collected only) In both patient groups: • Adverse event profile - 4 weeks after immunisation (Day 28 +/- 48 hours). • Full blood count and lymphocyte subsets, Serum protein electrophoresis and immunoglobulin levels, T-cell receptor excision circles (measurement of thymic activity), Serum cytokines (at minimum IL7, IL15, IL21), Autoantibody levels, Disease activity score using 28 joints (DAS28), ACR Core Criteria - at combined screening/baseline visit only.
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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
    matched cohort, open-label 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 Yes
    E.8.2.3.1Comparator description
    previous alemtuzumab recipients versus matched controls (matched for disease duration, age & gender)
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 will be the last participant's final study contact, at 4 weeks post-immunisation follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    The MHRA have defined the alemtuzumab (administered to the alemtuzumab recipients at Cambridge between 1991 and 1994) as the IMP for this study. The vaccines (NIMPs for the purpose of this study) will be administered to relevant eligible participants at the baseline visit only. All three vaccines are used to protect against infectious diseases, in healthy individuals and in patients with diseases such as rheumatoid arthritis.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation West Anglia CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-20
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