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    Summary
    EudraCT Number:2007-003288-36
    Sponsor's Protocol Code Number:C0168Z05
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-003288-36
    A.3Full title of the trial
    A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA)
    A.3.2Name or abbreviated title of the trial where available
    RESTART
    A.4.1Sponsor's protocol code numberC0168Z05
    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 SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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 Yes
    D.2.1.1.1Trade name Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRemicade
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    D.3.9.3Other descriptive nameChimeric Human-Murine IgG1 <Monocolonal Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 typeMonoclonal Antibody
    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.1.2Version 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 evaluate the efficacy of infliximab at week 10 in patients with active RA who are having an inadequate response to therapy with etanercept or adalimumab.
    E.2.2Secondary objectives of the trial
    To assess clinical response, physical function, and health-related quality of life through week 26 in patients with active RA who are having a inadequate response to etanercept of adalimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have Active RA, defined as DAS28 score ≥3.6, at screening visit and at baseline;
    - Have ≥6 swollen and ≥ 6 tender joints
    - Have an inadequate response to treatment with aternecept or adalimumab, at an approved and stable dose in combination with MTX, for a minimum treatment period of at least 3 months prior to the screening visit. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab infusion. The last dose of etanercept must have been administered at least 1 week before but not more than 2 weeks before the first infliximab infusion.
    - Are capable of providing written informed consent. Written informed consent must be obtained prior to performing any study-related procedures.
    - Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.
    - Are male of female and 18 years or older
    - Women of childbearing potential must test negative for pregnancy and be using birth control measures during the study and for 6 months after receiving the last administration of infliximab. Likewise, men capable of fathering children must also use appropriate methods of birth control.
    - Must have decided a stable dose of ≥ 7.5 mg/week MTX for at least 4 weeks prior to screening.
    - If using NSAIDS for RA, must be on a stable dose for at least 4 weeks before screening.
    - If using oral corticosteroids, must be on a stable dose equivalent to ≤ 10 mg of prednisone/day for at least 4 weeks before screening. If currently not using corticosteroids, the patient must have not received oral corticosteroids for at least 4 weeks before screening.
    - Are considered eligible according to the following TB screening criteria:
    - Have no history of latent of active TB prior to screening;
    - Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
    - Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation to rule out latent or active TB;
    - Within 1month prior to the first administration of infliximab, have a negative tuberculin skin test, as outlined in Appendix A
    - The screening laboratory tests must meet the following criteria:
    - Hemoglobin > 8.5 g/dL
    - White blood cell (WBC) count > 3.5 x 10,9 cells/L
    - Neutrophils > 1.5 x 10,9 cells/L
    - Platelets >100 x 10,9 cells/L
    - Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) levels must be within 2 times the upper limit of normal (ULN) for the laboratory conducting test. Alkaline phosphatase levels must be within 3 times ULN for the laboratory conducting the test.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria may not be enrolled in the study:
    - Have a history of latent or active granulomatous infection, including TB, histoplasmosis, of coccidioidomycosis, prior to screening, or are frequently in contact with individuals who carry active TB infection
    - Had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening;
    - Have a chest radiograph within 3 months prior to the first administration of infliximab that shows an abnormality suggestive of a malignancy of current active infection, including TB;
    - Have had a nontubercolous mycobacterial infection of opportunistic infection within 6 months prior to screening;
    - Have inflammatory diseases other than RA, including but not limited to Psoriatic Arthritis, Ankylosing Spondylitis, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of infliximab therapy;
    - Are receiving treatment with DMARD/systemic immunosuppressives other than MTX at screening. In patients exposed to leflunomide within the 6 months prior to the screening visit, plasma levels of leflumonide must be < 0.02 mg/L for at least 14 days before screening;
    - Have ever received infliximab;
    - Have ever received certolizumab pegol;
    - Have received treatment with more tha 1 TNFα inhibitor;
    - Have received treatment with abatacept, alefacept, efalizumab or rituximab during the 3 months prior to screening;
    - Have used any investigational drug within 3 months prior to screening;
    - Have or develop a concurrent disease or require medication(s) that could compromise efficacy assessments during the study;
    - Have a documented HIV infection;
    - Have documented current active Hepatitis B or a history of documented hepatitis C infection;
    - Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product;
    - Have a known allergy to murine proteins or other chimeric proteins;
    - Are pregnant, nursing or planning pregnancy during the trial within the 6-month period thereafter;
    - Are currently participating or are likely to participate in another investigative trial using an investigational agent, procedure, or medical device during participation in this trial;
    - Have a current diagnosis or a history of systemic lupus erythematous or lupus-like syndrome; severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases;
    - Have a transplanted organ;
    - Have had a chronic or recurrent infectious disease including but not limited to chronic renal infection; chronic chest infection; sinusitis; recurrent urinary tract infection; open, draining, of infected skin wound of ulcer;
    - Have any known malignancy of history of malignancy prior to screening;
    - Have multiple sclerosis or other central demeylinating disorder;
    - Have a serious concomitant illness that could interfere with the patient’s participation in the trial;
    - Have a history of substance abuse within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the patient’s adherence to protocol requirement;
    - Have a concomitant diagnosis or any history of congestive heart failure;
    - Are unable of unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy evaluation is the proportion of patients who achieve EULAR response at week 10.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    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
    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 months0
    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 months0
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    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)
    NA
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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