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    EudraCT Number:2011-003622-27
    Sponsor's Protocol Code Number:A3921086
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2011-003622-27
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A.4.1Sponsor's protocol code numberA3921086
    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, 235 East 42nd Street, New York, New York 10017
    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 number001303739 1119
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 assess the safety and tolerability of long-term open-label (OL) tofacitinib therapy in subjects with CD.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of OL tofacitinib maintenance therapy on clinical remission in subjects with CD.

    • To evaluate the effect of OL tofacitinib maintenance therapy on quality-of-life in subjects with CD.

    • To evaluate the effect of OL tofacitinib maintenance therapy on biomarkers as measured by CRP and fecal calprotectin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure
    2. Women of childbearing potential must test negative for pregnancy prior to study enrolment.
    3. 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. No specific contraceptive measures are required in male subjects during study participation (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 of the protocol).
    4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    5. Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will be excluded from the study:
    1. Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
    2. Subjects who were discontinued from the A3921084 study due to an adverse event that was not related to Crohn's disease.
    3. Evidence of active (draining) fistulae, intrabdominal or perineal collection or abscess at Baseline (MRI imaging is not required for entry to this study unless clinically indicated).
    4. Subjects with evidence of or suspected liver disease ie, liver injury due to methotrexate or primary sclerosing cholangitis.
    5. Subjects with evidence of blood dyscrasias at Baseline visit (as assessed by the laboratory results from Week 26 or early discontinuation visit from the A3921084 study):
    • Hemoglobin levels <9.0 g/dL
    • An absolute white blood cell (WBC) count of <3.0 x 10 to the power of 9/L (<3000/mm3) or absolute neutrophil count of <1.2 X 10 to the power of 9/L (<1200/mm3) or absolute lymphocyte count of <0.5 x 10 to the power of 9/L (<500/mm3).
    • Thrombocytopenia, as defined by a platelet count <100 x 10 to the power of 9/L (<100,000/mm3).
    6. Subjects who have been scheduled to receive any live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug. (see Section 4.4.4 of the protocol for further information on avoidance of household contacts who may be vaccinated with live virus).
    7. Women who are pregnant or breastfeeding or planning pregnancy during the study period.
    8. Subjects with estimated GFR ≤40 mL/min based on Cockcroft-Gault calculation from Week 26 or early discontinuation visit from the A3921084 study.
    9. Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal from Week 26 or early discontinuation visit from the A3921084 study.
    10. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, or neurological disease.
    11. Baseline 12-lead ECG (from Week 26 or early discontinuation visit from the A3921084 study) that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results (ie, baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias; see Appendix 3 of the protocol).
    12. Subjects who are expected to receive prohibited concomitant medications (see Appendix 2 of the protocol) including medications that are either moderate to potent CYP3A4 inducers or inhibitors during the study period.
    13. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    14. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    16. Subjects who are participating in or interested in participating in other investigational studies during study A3921086.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    - Incidence and severity of adverse events.
    - Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values.
    - Incidence of clinically significant changes in physical examination from baseline.
    - Incidence of vital sign abnormalities and changes from baseline in vital sign measures.
    - Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment.
    - Summary of adjudicated cardiovascular endpoints.
    - Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All safety endpoints are measured at every clinic visit throughout the duration of the study (52 weeks)
    E.5.2Secondary end point(s)
    Efficacy endpoints

    - Sustained clinical remission at both Week 24 and Week 48.
    - The proportion of all subjects in clinical remission and sustained clinical remission at Week 48.
    - The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline.
    - The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response or clinical remission at A3921086 baseline.
    - The median time to relapse among subjects in clinical remission at baseline.
    - CDAI scores over time and change from baseline
    - The proportion of subjects achieving a steroid-free clinical remission at Week 48.
    - Corticosteroid use over time.
    - Serum CRP and fecal calprotectin over time and change from baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All efficacy endpoints are measured at times specified in above section.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Czech Republic
    Korea, Republic of
    South Africa
    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 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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days12
    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.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 30
    F.4.2.2In the whole clinical trial 60
    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)
    Considering that this is a phase 2b study, there is no plan for tofacitinib treatment to continue following the end of the A3921086 study subject participation.
    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 Decision2013-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-25
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