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    Summary
    EudraCT Number:2006-005800-15
    Sponsor's Protocol Code Number:MRCG060329
    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:2007-08-01
    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 number2006-005800-15
    A.3Full title of the trial
    Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection
    A.3.2Name or abbreviated title of the trial where available
    TOPPIC
    A.4.1Sponsor's protocol code numberMRCG060329
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN89489788
    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 SponsorUniversity of Edinburgh
    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 supportMedical Research Council
    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
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    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 supportMedical Research Council (Grant MRC G060329)
    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
    B.Sponsor: 3
    B.1.1Name of Sponsor
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsor
    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 organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointMarise Bucukoglu (ACCORD Office)
    B.5.3 Address:
    B.5.3.1Street AddressQMRI, 47 Little France Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312429262
    B.5.5Fax number01312429447
    B.5.6E-mailMarise.Bucukoglu@ed.ac.uk
    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 6-Mercaptopurine (Puri-Nethol)
    D.2.1.1.2Name of the Marketing Authorisation holderAlkopharma Sarl
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 name6-Mercaptopurine (Puri-nethol)
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) 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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease is a serious disease in which there is swelling and ulceration of the gut wall. Symptoms may include pain, tiredness and the feeling of being generally unwell.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does 6-Mercaptopurine (also known as 6-MP) prevent or delay recurrence of Crohn's disease after surgery?
    E.2.2Secondary objectives of the trial
    We shall also address these secondary research questions: 1. Can faecal calprotectin be used as a non-invasive marker of disease recurrence that may remove the need for colonoscopy in some patients? Calprotectin is a stable neutrophil derived faecal protein, that correlates with disease activity. Elevated calprotectin predicts relapse in patients in a medically induced remission but has not been assessed in the postoperative setting. 2. Do drug metabolite levels relate to clinical efficacy of 6MP? 3. Can we predict postoperative recurrence using clinical, genetic or serological data? The recent Montreal classification of Crohn’s disease has identified the need to integrate clinical, genetic and serological data. This study provides the opportunity to perform exploratory analyses of this data in a prospective, rigorously phenotyped cohort. 4. Does 6MP prevent or delay endoscopic evidence of recurrence? 5. Does endoscopic recurrence predict clinical recurrence?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 16 years of age in Scotland and 18 years of age in England and Wales. 2. Established diagnosis of Crohn’s disease confirmed at recent resection. 3. Ileocolonic or small bowel resection within 3 months before screening. 4. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable. 5. Able to start oral nutrition within the first 2 postoperative weeks. 6. Normal or heterozygous TPMT (activity present or reduced consistent with carrier status). 7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol. 8. Off antibiotics 2 weeks prior to randomisation.
    E.4Principal exclusion criteria
    1. Pregnancy at baseline or breast feeding. 2. A known hypersensitivity or intolerance to 6MP. 3. Pancreatitis associated with azathioprine. 4. Receiving an experimental treatment for Crohn’s disease in the 4 weeks prior to study entry. 5. Known to require further surgery at study entry i.e. for the removal of an abscess developing from the primary surgery. 6. Stricturoplasty procedure alone (Please note that stricturoplasty and resection procedure together will not be considered an exclusion.) 7. Presence of stoma. 8. Significant haematological, renal or hepatic dysfunction or clinically important lung disease (i.e. liver function tests >x2 upper limit of normal, Haemoglobin ≤10, total white blood cell count <3.5, Neutrophils <1.5, Platelets <100x106/l). 9. Systemic infection including hepatitis B, hepatitis C, HIV and active TB. 10. A diagnosis of indeterminate colitis or ulcerative colitis. 11. A history of illicit drug or alcohol abuse in the 1 year prior to study entry. 12. Active or untreated malignancy (excluding basal cell carcinoma and insitu tumours). (Patients who have had successful treatment for malignancy and have been in remission for more than 5 years may be considered for inclusion only after detailed discussion with, and written approval, from the patient's medical oncologist.) 13. Presence of a medical or psychiatric condition, disease or laboratory abnormality that in the opinion of the PI may place the subject at unacceptable risk during the study. 14. Homozygous deficient for TPMT (absent activity) 15. Evidence of untreated post-operative infection e.g. clostridium difficile, urinary tract infection or chest infection. If these have been appropriately treated in the opinion of the PI, and inclusion criteria 8 is met, this will not be considered an exclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical recurrence of Crohn’s disease (defined by a CDAI value of greater than 150 together with a 100 point rise in the CDAI score from baseline)), together with the need for anti-inflammatory rescue therapy or primary surgical intervention.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Assessment Table (Page 29 of the Protocol) details all evaluation points for the trial.
    E.5.2Secondary end point(s)
    1. The need for a second operation to remove recurrent Crohn’s disease from the anastomotic site. 2. Changes in self rated quality of life scores. 3. Endoscopic recurrence using the Rutgeerts scoring system. 4. Clinical recurrence of Crohn's disease (defined by a CDAI value of greater than 150 together with a 100 point rise in the CDAI score from baseline), OR the need for anti-inflammatory rescue therapy or primary surgical intervention.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Assessment Table (Page 29 of the Protocol) details all evaluation points for the trial.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned30
    E.8.5The trial involves multiple Member States No
    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 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
    The end of study is defined as the last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state234
    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)
    Recruitment is over a 4.5 year period, followed by up to a 3 year treatment period for each patient. Patients will be informed that a summary of results will be published on the Edinburgh Clinical Trials Unit website and patients can find out if they were taking 6-MP or the placebo. A previous study has shown that the effects of the drug wear off after 4 years, suggesting that there is little point in taking it for longer than 4 years.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-30
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