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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2007-004867-22
    Sponsor's Protocol Code Number:108UC201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2007-004867-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.
    A.4.1Sponsor's protocol code number108UC201
    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 SponsorBiogen Idec Ltd
    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 Yes
    D. name Avonex
    D. of the Marketing Authorisation holderBiogen Idec Ltd
    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 nameAvonex
    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 IMPIntramuscular 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. 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) Yes
    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.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 placeboIntramuscular 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 Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 objective of this study is to evaluate the clinical activity of AVONEX in subjects with moderate to severe UC.
    The primary endpoint is clinical response at Week 8, defined as a decrease from baseline in the Total Mayo Score/Disease Activity Index (DAI) of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 0 or 1.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine (i) the safety and tolerability of AVONEX in subjects with moderate to severe UC, and (ii) the percentage of subjects with a decrease in the SCCAI score of =/> 3 points at Week 8.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of Screening:
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
    2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
    3. Must have an established diagnosis of UC for =/>6 months.
    4. Must have endoscopy (flexible sigmoidoscopy or colonoscopy if clinically indicated) with biopsy to confirm the diagnosis of UC.
    5. Must have >20 cm of active disease at Screening endoscopy.
    6. Must have active UC with a Mayo Score/DAI of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment with corticosteroids, azathioprine, 6-mercaptopurine, 5-aminosalicylic acid (5-ASA) or any combination thereof.
    7. Colonoscopy within the past 5 years for extent of disease .
    8. For subjects with UC for >10 years, colonoscopy with appropriate biopsies within 1 year prior to Screening to exclude dysplasia and neoplasia.
    9. At the time of screening, subjects must be receiving 1 or more of the following treatments, or any combination thereof, and must be willing to maintain stable doses of these treatments after randomisation at Week 0 (Visit 1): corticosteroids, azathioprine, 6-mercaptopurine, or 5-ASA as follows:
    a. If receiving corticosteroid treatment prior to screening, subjects must be willing to maintain stable doses until Week 8.
    b. If receiving azathioprine or 6-mercaptopurine prior to screening, subjects must have taken stable doses for at least 12 weeks prior to screening and be willing to maintain stable doses until at least Week 8.
    c. If receiving 5-aminosalicylic acid prior to screening, subjects must have taken stable doses for at least 2 weeks prior to screening and be willing to maintain stable doses until at least Week 12.
    10. Subjects must be willing and able to comply with a 7-day UC symptom collection by IVRS telephone diary as assessed during the Screening period.
    11. All male subjects and female subjects of child bearing potential must be willing and able to practice effective birth control during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.
    For purposes of this study, effective contraception is defined as follows:
    For females:
    • Using 1 or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), intrauterine contraception/device, hormonal contraception, or any 2 barrier methods (a combination of male or female condom with spermicide, diaphragm, sponge, cervical cap).
    • Abstinence, at the discretion of the Investigator, can be considered an acceptable method of contraception. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    For males:
    • Effective male contraception includes a vasectomy with negative semen analysis at follow-up, or the use of condoms with spermicide.
    For purposes of this study, women of child-bearing potential (WOCBP) are defined as all women physiologically capable of becoming pregnant, UNLESS they meet the following conditions:
    • Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
    Reliable contraception for both males and females should be maintained throughout the study.
    E.4Principal exclusion criteria
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening:
    1. Subjects with a diagnosis of indeterminate colitis or Crohn’s disease.
    2. Subjects with clinical findings suggestive of Crohn’s disease, e.g., fistulae or granulomas on biopsy.
    3. Subjects with an imminent need for surgery.
    4. Subjects with toxic megacolon.
    5. Subjects with primary sclerosing cholangitis.
    6. Any of the following abnormal laboratory results:
    • ALT and AST =/>2xULN
    • Hemoglobin =/<9 g/dL
    • WBC <3500 cells/mm3
    • Lymphocyte count <1000 cells/microLitre
    • Platelet count <100,000 cells/microLitre

    7. Female subjects who are pregnant or who wish to become pregnant during the study, or who are lactating.
    8. Subjects with known symptomatic colonic stricture.
    9. Stool cultures positive for enteric infection, including parasitic and C. difficile infection.
    10. Subjects who are positive for HBsAg, HCV, or HIV at Screening.

    11. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
    12. History of severe depression and / or suicidal ideation
    13. History of severe allergic or anaphylactic reactions.
    14. History of intolerance to acetaminophen (paracetamol) that would preclude its use during the study period.
    15. Subjects with a history of major abdominal surgery (e.g. gastrectomy) within the past 5 years.
    16. Subjects with a history of colonic or small bowel obstruction or resection.
    17. History of any clinically significant cardiac disease (including cardiomyopathy, congestive heart failure or related risk factors) or endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (including untreated or unstable seizures), dermatologic, renal, and psychiatric or other major disease, as determined by the Investigator. This includes psychosis, schizophrenia, mania, or major psychiatric illness requiring pharmacological treatment. Patients with a clinical diagnosis of anorexia nervosa or bulimia nervosa are excluded from the study.
    18. Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening.
    19. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 6 months prior to Screening.
    20. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Screening.

    21. Treatment with another study treatment or approved therapy for investigational use within the 4 weeks prior to the first dose of study treatment.
    22. Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within 8 weeks prior to Screening.
    23. Treatment with anti-TNF agents within 12 weeks prior to Screening.
    24. Treatment with methotrexate, cyclosporine, tacrolimus, sirolimus, or mycophenylate mofetil within 8 weeks prior to Screening.
    25. Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than low-dose aspirin within 4 weeks prior to Screening.
    26. Use of oral antibiotics for any reason within 2 weeks prior to Screening.
    27. Treatment with rectally administered corticosteroids or rectally administered medications containing 5 aminosalicylates within 2 weeks prior to Screening.
    28. Use of antidiarrheal agents during the screening period (between Screening and Visit 1).
    29. Previous participation in this study.
    30. Previous treatment with interferon beta or other interferon products.

    31. Blood donation (1 unit or more) within 2 months prior to Screening.
    32. Current enrollment in any other study treatment or disease study.
    33. Inability to comply with study requirements.
    34. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response at Week 8, defined as a decrease from baseline in the Total Mayo Score/Disease Activity Index (DAI) of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 0 or 1.
    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 No
    E. trial type description
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    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 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
    last subject last visit
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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 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 2008-02-26. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-08
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