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    Summary
    EudraCT Number:2008-000982-51
    Sponsor's Protocol Code Number:P05336
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-000982-51
    A.3Full title of the trial
    Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial
    A.3.2Name or abbreviated title of the trial where available
    INFAST
    A.4.1Sponsor's protocol code numberP05336
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern/a
    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 SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    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 Yes
    D.2.1.1.1Trade name Remicade 100 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    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.3.10 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Diclofenac-ratiopharm 75mg SL sustained release capsules
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namediclofenac
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdiclofenac
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Information not present in EudraCT
    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 placeboPowder for concentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-severe active axial spondyloarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058338
    E.1.2Term Spondylarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy endpoint is the proportion of subjects meeting the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria at Week 28. The primary objective is to assess the proportion of subjects in the infliximab plus diclofenac arm versus the placebo plus diclofenac arm, in a population of subjects with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the ASAS partial remission criteria.
    E.2.2Secondary objectives of the trial
    Compare the proportion of subjects in ASAS partial remission at Wk 52/ET who are on diclofenac(DLO) vs those without therapy(tx) between Wks 28-52;Assess the proportion of subjects in the infliximab(IFX)+DLO arm vs the placebo(PBO)+DLO arm who achieve ASAS partial remission at Wk 52/ET;Assess the effect of IFX+DLO vs pbo +DLO on the change of or absence of active inflammatory lesions on MRI of the spine and sacroiliac joints(SIJ); Assess the effect of DLO vs no tx between Wks 28-52/ET on the change of or absence of active inflammatory lesions on MRI of the spine and SIJ;Compare the duration of remission between DLO treatment with stopping all AS-tx’s between Wks 28 and 52/ET;To compare the % of subjects in ASAS partial remission who flare with DLO maintenance tx vs no maintenance;Compare the % of subjects achieving ASAS-40 and ASAS-20 in the INF +DLO arm with the PBO+DLO arm;Compare the % of subjects achieving ASAS-40 and ASAS-20 with diclofenac maintenance tx vs no maintenance tx
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be willing to give written informed consent & be able to adhere to the dose & visit schedules
    2. Subject must be 18 to 48 yrs of age, of either sex, & of any race
    3. Subject must have a diagnosis of active axial spondyloarthritis, w/disease duration of ≤3 yrs, based on ALL of the following findings: chronic low back pain (for a duration of >3 months to ≤3 yrs, with onset before the age of 45), active inflammatory lesions of the sacroiliac joints shown on MRI. Active inflammatory lesions are defined as bone edema within or adjacent the sacroiliac joints, compatible w/active lesions seen in AS or axial spondyloarthritis as observed w/short inversion recovery (STIR). One or more of the following spondyloarthritis manifestations: Inflammatory back pain according to Calin Criteria or Rudwaleit et al, Uveitis, Arthritis, Dactylitis, Psoriasis, History of CD/ulcerative colitis, HLA-B27 positive, good response to NSAIDs, CRP levels elevated above upper limit of normal (local lab), positive family history for Spondyloarthritis, Enthesitis
    4. Subject must have active disease at Screening & Baseline defined by both a total back pain evaluation of ≥40 mm on a VAS of 0 to 100 mm AND a BASDAI score of ≥40 mm
    5. Subject must meet 1 of the following criteria: be NSAID-naïve, OR if subject has been treated with an NSAID before Screening, average dose during the last 2 wks must not have escalated to more than two-thirds of the maximal recommended dose, AND in addition a washout period of ≥3 days has occurred before Baseline
    6. Subject who is on an NSAID at Screening (& goes through a ≥3-day washout period before Baseline) must have an increase in total back pain of ≥30% at Baseline visit compared to Screening visit as measured by the Total Back Pain VAS
    7. Women of childbearing potential & all men must agree to use a medically accepted method of contraception prior to entering the study while receiving protocol-specified medication, & for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without spermicide, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, & surgical sterilization (eg, hysterectomy, tubal ligation for women, and vasectomy for men).Women of non-childbearing potential do not have to use any contraceptive methods
    8. Women of childbearing potential & men who are not currently sexually active must agree to use a medically acceptable method of contraception should they become sexually active while participating in the study & receiving protocol-specified medication or within 6 months after stopping the medication
    9. Subject is considered eligible according to the following tuberculosis (TB) criteria:
    has no history of latent or active TB within 3 months prior to Screening (according to local standards and laws), has no signs or symptoms suggestive of active TB upon medical history &/or physical examination during Screening, has 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, & have active and latent TB ruled out (according to local standards and laws) prior to first administration of study medication. In the case of a positive TB-test (as per local standards and laws), a subject can participate in this trial only if the subject agrees to & is able to receive TB prophylaxis with isoniazid 300mg once daily starting from 4 wks prior to Baseline and until Wk 28 of the trial. In the case of isoniazid intolerance, rifampin can be an alternative. Subject must have a chest x-ray available from within the previous 3 months prior to Screening visit showing a negative outcome (no clinically significant findings). But if such a negative chest x-ray is not available, then subject must have a chest x-ray performed during the Screening visit showing a negative outcome
    10. Subject must have Screening laboratory tests within the following parameters:
    Hemoglobin (hgb) ≥10 g/dL (≥100 g/L), White blood cells (WBC) ≥3.5 x 109 cells/L, Neutrophils ≥1.5 x 109 cells/L, Platelets ≥100 x 109 cells/L, Lymphocytes >1.0 x 109 cells/L, Serum creatinine <1.5 mg/dL (<133 micromol/L), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, & gamma-glutamyltransferase (GGT) all ≤2 times upper limit of normal, Total bilirubin ≤1.5 times upper limit of normal
    11. Subject must have an x-ray of the sacroiliac joints available from within the previous 12 months prior to Screening visit. But if such an x-ray is not available, then the subject must have an x-ray of the sacroiliac joints performed during the Screening visit. Subjects will not be excluded based on the results of this x-ray
    E.4Principal exclusion criteria
    1. Subject has history of esophageal, gastric, pyloric channel, or duodenal ulceration or any clinically relevant gastrointestinal bleeding w/in 5 yrs prior to Screening
    2. Subject has evidence of active inflammatory bowel disease (CD or UC)
    3. Subject has clinical gastrointestinal malabsorption, regardless of etiology
    4. Subject has uncontrolled hypertension as per the discretion of treating physician.
    5. Subject has history of coronary heart disease, myocardial infarction, stroke, transient ischemic attack, or has a diagnosis of congestive heart failure, even if the subject is medically controlled &/or asymptomatic
    6. Subject has another chronic inflammatory articular disease or systemic autoimmune disease such as Systemic Lupus Erythematosus, Sjogren’s syndrome, active rheumatoid vasculitis, or chronic fatigue syndrome
    7. Subject w/a history of chronic or recurrent infectious disease including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), & recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, infected skin wounds or ulcers, or a history of recurrent bacterial infections w/encapsulated organisms
    8. Subject has/had an opportunistic infection (infection caused by an organism such as cytomegalovirus, Pneumocystis carinii, aspergillus, histoplasmosis, or mycobacteria other than TB, in a host whose resistance is lowered by another disease or drug[s]) w/in 6 months prior to Screening
    9. Subject has/had herpes zoster infection w/in 2 months prior to Screening.
    10. Subject is known to be infected w/human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
    11. Subject has primary or secondary immunodeficiency
    12. Subject has known history of lymphoproliferative disease, including lymphoma, or signs & symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size/location
    13. Subject has any known malignancy or history of malignancy w/in the previous 5 yrs (w/the exception of basal cell carcinoma of the skin that has been treated w/no evidence of recurrence for 1 yr prior to Screening)
    14. Subject has had previous treatment w/a TNF-alpha targeted therapy or another biological agent
    15. Subject has been on leflunomide during the previous 8 wks prior to Screening (or during the previous 4 wks prior to Screening if subject has undergone standard cholestyramine or activated charcoal washout)
    16. Subject has been on DMARDs, sulfasalazine, methotrexate, a corticosteroid (oral, intra-articular, or parenteral) during the previous 4 wks prior to Screening
    17. Subject has history of or current signs &/or symptoms of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary (eg, pulmonary insufficiency), cardiac, neurological, cerebral, or psychiatric disease
    18. Subject has history of demyelinating disease, symptoms suggestive of multiple sclerosis or optic neuritis
    19. Subject has a transplanted organ (w/the exception of a corneal transplant >3 months prior to Baseline)
    20. Subject has neuropathy that can interfere w/quality of life &/or pain assessment.
    21. Subject has known intolerance (including allergic reactions) to murine, chimeric proteins or human/murine recombinant products
    22. Subject for whom a known intolerance to or contraindication for infliximab exists, or for whom infliximab is not recommended
    23. Subject is not responsive to diclofenac, subject for whom a known intolerance to or contraindication for diclofenac exists, or for whom diclofenac is not recommended.
    24. Subject has used an immunosuppressant at any time w/in the previous 4 wks prior to Screening
    25. Subject has used any systemic medication (other than NSAIDs) that could affect active axial spondyloarthritis or study evaluations w/in the previous 4 wks prior to Screening
    26. Subject has received a live virus or bacterial vaccination w/in the previous 3 months prior to Screening or is expected to receive such a vaccination.
    27. Subject is a woman who is breastfeeding, pregnant, or intending to become pregnant.
    28. Subject is known to have had a substance abuse problem w/in the previous 3 yrs prior to Screening
    29. Subject has used an investigational drug at any time within the previous 4 wks prior to Screening
    30. Subject is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
    31. Subject is participating in any other clinical study
    32. Subject is part of staff personnel directly involved w/this study
    33. Subject is a family member of the investigational study staff
    34. Subject has any clinically significant laboratory result, medical condition, or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Efficacy Endpoint is related to the Primary Trial Objective.
    The Primary Efficacy Endpoint for the current trial is the proportion of subjects in each study arm (Arm A and Arm B) meeting the ASAS partial remission criteria at Week 28.

    The Primary Safety Endpoints for the current study are treatment-emergent serious adverse events (SAEs).
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) Yes
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 overall study ends when the last subject has completed or has been discointinued and the last protocol-specific contact (vistit or telefone contact) took place.
    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 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) No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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)
    N/A
    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 Decision2009-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-20
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