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    Summary
    EudraCT Number:2004-001876-37
    Sponsor's Protocol Code Number:CO168X71 (EU-0037)
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-02-27
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2004-001876-37
    A.3Full title of the trial
    BENEFIT-study: A randomized placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody ( infliximab) in idiopathic pulmonary fibrosis.
    A.3.2Name or abbreviated title of the trial where available
    BENEFIT
    A.4.1Sponsor's protocol code numberCO168X71 (EU-0037)
    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 SponsorAcademic Medical Centre
    B.1.3.4CountryNetherlands
    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 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 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 nameRemicade
    D.3.4Pharmaceutical form Powder 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.3.11 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 No
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 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
    Idiopathic Pulmonary Fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the study are to establish that the administration of monoclonal antibody anti-TNF-alpha in patients with IPF:
    * Affects inflammatory and pro-fibrotic cytokine expression in broncho-alveolar lavage and blood.
    E.2.2Secondary objectives of the trial
    * Has a potential beneficial effect on disease progression.
    * Is tolerable and safe.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients to be included must meet the following criteria:

    1. Diagnosis of IPF(2):
    a) If possible a thoracoscopic or open lung biopsy showing UIP. A thoracoscopic or open lung biopsy must be performed in patients <51 years old. Transbronchial biopsy is strongly advocated and should show no features to support an alternate diagnosis.
    b) Insidious onset of otherwise unexplained dyspnea on exertion.
    c) Presence of bibasilar, inspiratory crackles.
    d) Abnormal lung function: VC £ 80% predicted or TLC < 90% predicted, plus DLco < 80% predicted.
    e) Parenchymal abnormalities on chest X-ray.
    f) HRCT: bilateral parenchymal abnormalities with peripheral and bibasilar distribution showing linear and reticular opacities, usual in conjunction with subpleural honeycombing and architectural distortion.
    g) Exclusion of other forms of interstitial lung diseases.
    h) In patients > 50 years fulfilling all above mentioned criteria a BAL to exclude other causes of interstitial lung disease is sufficient and a lung biopsy is not necessary.

    2. Show stable disease or failure to respond to standard medication (i.e. azathioprine and prednisolone) (as defined by the ATS/ERS criteria(2)) during a minimum of 3 months prior to the study, with a minimum dose of prednisolone (or equivalent) of 20 mg daily, and azathioprine 2 mg per kg with a maximum of 200 mg daily during 3 months.

    3. Men and women between 40 and up until 79 years.

    4. Disease duration between 3 months and 2 years.

    5. Men and women must use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.

    6. The screening laboratory test results must meet the following criteria:
    a. Haemoglobin ³ 8.5 g/dL (5.3 mmol/L)
    b. WBC ³ 3.5 x 109/L
    c. Neutrophils ³ 1.5 x 109/L
    d. Platelets ³ 100 x 1012/L
    e. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test.

    7. Patient must be able to adhere to the study visit schedule and other protocol requirements.

    8. Patient must be able to communicate meaningfully with the study personnel.

    9. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.

    10. Must have a chest radiograph within 3 months prior to first infusion with no evidence of malignancy or infection.

    11. Are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules as decribed in section 4.3.
    E.4Principal exclusion criteria
    Patients will be excluded from this study for any of the following reasons:

    1. Critical low lung function: FVC < 50%.

    2. Artificially ventilated.

    3. Inability to undergo a broncho-alveolar lavage.

    4. Patients that were treated with IFN-γ.

    5. Women who are pregnant, nursing, or planning pregnancy within 1,5 years after screening (ie, approximately 6 months following last infusion).

    6. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

    7. Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline, thalidomide, etanercept, adalimumab etc.) within 3 months of screening.

    8. Previous administration of infliximab.

    9. History of receiving human/murine recombinant products or known allergy to murine products.

    10. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.

    11. Documented HIV infection.

    12. Active hepatitis- B or hepatitis-C.

    13. Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 4.3.

    14. Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening..

    15. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).

    16. Concomitant congestive heart failure and/or cor pulmonale, including medically controlled asymptomatic patients. Criteria for cor pulmonale are based on cardiac sonography: estimated systolic pulmonary artery pressure ≥ 40 mmHg at rest.

    17. Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).

    18. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).

    19. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.

    20. Known recent substance abuse (drug or alcohol).

    21. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.

    22. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Section 4.3.2.1

    E.5 End points
    E.5.1Primary end point(s)
    -Change in FVC from baseline.
    -Time to disease progression (ATS criteria)(2).
    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 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 Yes
    E.7.1.3.1Other trial type description
    phase II b
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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 Decision2007-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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