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    Summary
    EudraCT Number:2011-001733-16
    Sponsor's Protocol Code Number:A3921083
    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:2011-12-22
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-001733-16
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL
    GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND
    EFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease
    A.4.1Sponsor's protocol code numberA3921083
    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 SponsorPfizer Inc.
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street,
    B.5.3.2Town/ cityNew York,
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.com
    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 No
    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 nameTofacitinib
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTofacitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboFilm-coated tablet
    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
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    E.1.2System Organ Class 100000004856
    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 the study is to evaluate the dose-response of tofacitinib in inducing clinical remission in subjects with moderate to severe Crohn’s disease and to select effective dose(s).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of tofacitinib induction therapy in subjects with moderate to severe Crohn’s disease.
     To evaluate the dose-response of tofacitinib in inducing clinical response in subjects with moderate to severe Crohn’s disease.
     To characterize the pharmacokinetics of tofacitinib in subjects with moderate to severe Crohn’s disease.
     To evaluate the effect of tofacitinib on quality of life in subjects with moderate to severe Crohn’s disease.
     To evaluate the effect of tofacitinib on CRP and fecal calprotectin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female subjects between the ages of ≥18 and ≤75 years at screening.
    2. Subjects with documented clinical diagnosis of Crohn’s disease (CD) for at least 6 months prior to screening.
    3. Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn’s Disease Activity Index (CDAI) of ≥220 to ≤450 at baseline.
    4. Subjects with a history of inadequate treatment response or intolerance (as defined by the Investigator) to at least one of the following therapies for Crohn’s disease:
    • Corticosteroids.
    • Azathioprine/6-Mercaptopurine.
    • Methotrexate.
    • Anti-TNF therapy (Infliximab; Adalimumab; Certolizumab pegol).
    5. Subjects currently receiving any of the following treatments for Crohn’s disease are eligible provided they are on stable dose for designated period of time and throughout the study:
    • Oral 5-ASA or sulfasalazine stable dose for at least 4 weeks prior to baseline.
    • Oral corticosteroids (prednisolone up to 30 mg/day; budesonide up to 9 mg/day) stable dose for at least 2 weeks prior to baseline.
    • Chronic treatment for Crohn’s disease with antibiotics (e.g. metronidazole, rifaximin) stable dose for at least 2 weeks prior to baseline.
    • Rectally administered formulation of corticosteroids or 5-ASA stable dose for at least 2 weeks prior to baseline.
    • Seton placement before enrollment must remain in place during the study.
    6. Subjects with presence of ulceration at screening/baseline colonoscopy as documented by the Simple Endoscopic Score for Crohn’s Disease (SES-CD): aphthous ulcers (0.1 to 0.5 cm), large ulcers (0.5 to 2 cm), or very large ulcers (>2 cm).
    7. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    • A chest radiograph taken at or within the 3 months prior to screening, without changes suggestive of active TB infection as determined by a qualified radiologist.
    • No history of either untreated or inadequately treated latent or active TB infection.
    • If a subject has previously received an adequate course of therapy for either latent (e.g., 9 months of isoniazid in a locale where rates of primary multi drug resistant TB infection are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a PPD test nor a QFT G test is needed, but a negative chest radiograph must still be obtained if not performed within 3 months prior to screening. Documentation of adequate treatment for TB will be obtained prior to first dose of study drug.
    • A subject who is currently being treated for active TB infection is to be excluded.
    • A subject who is currently being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi-drug resistant TB infection in the locale, documentation of an adequate treatment regimen, and with prior approval by the Sponsor.
    8. Women of childbearing potential must test negative for pregnancy prior to study enrolment.
    9. Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. (Further description of the requirements and a list of contraceptives considered effective and acceptable for use in this trial are found in Section 4.4 Life Style
    Guidelines in the protocol).
    10. Subjects receiving non-prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new medication or changing dosage of a current medication within 7 days or 5 half-lives (whichever is longer) prior to baseline.
    11. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    12. Evidence of a personally signed and dated informed consent
    document indicating that the subject (or a legal representative) has
    been informed of all pertinent aspects of the study.
    E.4Principal exclusion criteria
    1.Diagnosis of indeterminate colitis, UC, or clinical findings suggestive of UC. 2.Subjects diagnosed with Crohn's disease but without previous exposure to treatment or having failed or been intolerant to treatment solely with 5 ASA containing compounds. 3.Subjects receiving treatment for Crohn's disease (see protocol for list of treatments). 4.Other investigational or marketed biologics with immunomodulatory properties within 3 months prior to baseline. 5.Subjects who have previously received natalizumab, or any anti adhesion molecule, within 1 year prior to baseline. 6.Leukocyte apheresis including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months. 7.Subjects who have previously participated in any study of tofacitinib. 8.Participation in other interventional clinical studies within 3 months prior to baseline and/or during study. 9.History of symptomatic obstructive strictures unless the stricture has been surgically treated or treated with dilation without recurrence of symptoms for at least 6 months prior to enrollment, or an active ostomy. 10.History of total colectomy or subtotal colectomy to the extent that it precludes the subject from having any formed stool, extensive small bowel resection (>100 cm) or short bowel syndrome. 11.History of bowel surgery within 6 months prior to baseline. 12.Subjects likely to require any type of surgery during the study period. 13.Fecal culture/toxin assay indicating presence of pathogenic infection. 14.Presence of active (draining) fistulae, intra-abdominal or perineal collection or abscess.15.Subjects on elemental diet used for treating Crohn's disease within 7 days from baseline. 16.Subjects with blood dyscrasias at screening. 17.Subjects with evidence of or suspected liver disease eg, liver injury due to methotrexate or primary sclerosing cholangitis. 18.Subjects with estimated GFR <40 ml/min at screening, based on Cockcroft Gault calculation. 19.Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening. 20.Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 21.Subjects who
    have been vaccinated with any live or attenuated virus vaccine within 6 weeks of baseline or scheduled to receive live virus vaccination during study period and for 6 weeks after last dose of study drug. 22.Subjects with history of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease. 23.Subjects with clinically significant infections currently or within 6 months of baseline, a history of any infection requiring antimicrobial therapy within 2 weeks of baseline, or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study. 24.Subjects with a history of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex. 25.Subjects with prior treatment with lymphocyte depleting agents/therapies. Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to baseline. 26.Subjects with any condition possibly affecting oral drug absorption. 27.Women who are pregnant or breastfeeding, or planning pregnancy during the study period. 28.History of alcohol or drug abuse with less than 6
    months of abstinence prior to baseline. 29.Screening 12 lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results. 30. Subjects with history of blood donation in excess of 500 mL within 8 weeks prior to baseline. 31.Subjects with history of blood transfusion within 4 weeks prior to baseline. 32.Subjects with a first degree relative with a hereditary immunodeficiency. 33.Subjects with any malignancies or with a history of malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin. 34.Significant trauma or major surgery within 4 weeks of screening visit. 35.Subjects infected with HIV or hepatitis B or C viruses. 36.Subjects receiving prohibited concomitant medications including medications that are either moderate to potent CYP3A4 inducers or inhibitors in the specified time periods prior to the first dose of study drug or are expected to receive any of these medications during the study period. See Protocol for additional criteria and details.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in clinical remission at week 8 as defined by a Crohn’s disease
    activity index (CDAI) score of less than 150 points.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of subjects in clinical remission at week 8 as defined by a Crohn’s disease activity index (CDAI) score of less than 150 points
    E.5.2Secondary end point(s)
    The proportions of subjects in clinical remission (CDAI<150) at Week 2 and 4.
    The proportion of subjects achieving clinical response-70 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline.
    The proportion of subjects achieving clinical response-100 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline.
    The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI<150) at Week 2, 4, and 8.
    CDAI scores over time.
    Serum CRP and fecal calprotectin levels over time.
    Plasma tofacitinib concentration over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportions of subjects in clinical remission (CDAI<150) at week 2 and 4
    The proportion of subjects achieving clinical response-70 at week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline
    The proportion of subjects achieving clinical response-100 at week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline
    The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI<150) at week 2, 4, and 8
    CDAI scores over time
    Serum CRP and fecal calprotectin levels over time
    Plasma tofacitinib concentration over time


    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Bulgaria
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Japan
    Korea, Republic of
    Netherlands
    South Africa
    Spain
    Ukraine
    United States
    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
    EOT in all participating countries is defined as LSLV. EOT in a Member State of the EU is defined as time at which it is deemed that sufficient subjects have been recruited & completed the study as stated in regulatory application (ie, Clinical Study Application) &ethics application in the Member State (MS). Poor recruitment (recruiting less than the anticipated number in the CTA) by a MS is not a reason for premature termination but is considered a normal conclusion to the study in that MS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.1Number 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) No
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 275
    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)
    Subjects who complete to the week 8 visit may be eligible to consider entering a 26-week maintenance study (A3921084). Study drug will not otherwise be made available to subjects after the end of treatment. For subjects not entering A3921084, a follow up visit will be performed 4 weeks after their last dose of study medication.
    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 Decision2012-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-17
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