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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   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).

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    Summary
    EudraCT Number:2018-002378-30
    Sponsor's Protocol Code Number:A3921210
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2018-002378-30
    A.3Full title of the trial
    OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN-LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    A.4.1Sponsor's protocol code numberA3921210
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/009/2021
    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 Centre
    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 number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@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 Yes
    D.2.1.1.1Trade name XELJANZ
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameTofacitinib citrate
    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.3.8INN - Proposed INNtofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg
    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.IMP: 2
    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 citrate
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOFACITINIB
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1mg/mL
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
    E.1.1.1Medical condition in easily understood language
    MODERATE TO SEVERE ULCERATIVE COLITIS
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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
    Primary Objective(s):
    • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC.
    E.2.2Secondary objectives of the trial
    Secondary Objective(s):
    • To evaluate the overall efficacy of tofacitinib during induction during
    induction, maintenance and extension.
    • To evaluate the effect of tofacitinib on biomarkers.
    • To evaluate tofacitinib PK during induction and maintenance.
    • To evaluate taste acceptability of tofacitinib oral solution, and/or acceptability of tofacitinib film coated tablet, if applicable, at Week 2 of the open label induction phase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document and assent document (as appropriate) indicating that the subject or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.
    2. Males and females 2 to <18 years old and weighing at least 10 kg at baseline.
    3. Participants with a clinical diagnosis of UC for at least 12 weeks prior to baseline and with a pathology report that confirms colonic inflammation consistent with UC at any time prior to enrollment. A biopsy report supporting the diagnosis prior to the baseline visit must be available in the source documents (can be obtained from biopsies performed at screening if prior pathology report is not available). In addition, a report documenting disease duration and extent of disease (eg, proctosigmoiditis, left sided colitis, or pancolitis) based on prior endoscopy must also be available in the source documentation
    4. Participants diagnosed with UC at age less than 6 years old, must have had testing for very early onset (VEO) IBD and be negative for monogenic disorders associated with VEO IBD.
    5. Participants with moderately to severely active UC as defined (via screening endoscopy) by a Mayo score of ≥6, with a rectal bleeding score of ≥1 and an endoscopic subscore (Mayo) of ≥2 (assessed by local read). Endoscopy must be performed within 14 days of baseline visit. If the participant had a colonoscopy with biopsies showing no dysplasia or colon cancer within 12 months prior to baseline with appropriate documentation in source, then the baseline endoscopy may be either colonoscopy (with or without random biopsies) or flexible sigmoidoscopy (with or without random biopsies). However targeted biopsies should be obtained if there are observed abnormalities or lesions of clinical concern during endoscopy. All pathology reports must be available in the source document prior to enrollment.
    Note: The Mayo endoscopic subscore assessed locally will be used to derive the Mayo score to determine eligibility.
    6. Pediatric Ulcerative Colitis Activity Index (PUCAI) score >/= 35 at baseline.
    7. No history of dysplasia or colon cancer.
    8. No evidence or history of untreated or inadequately treated active or latent infection with Mycobacterium tuberculosis (TB).
    9. For participants outside of the US or the EU: have had an inadequate response or been intolerant to at least one prior therapy as listed below or have a medical contraindication to such therapies:
    • Oral or intravenous (IV) corticosteroids;
    • Azathioprine or 6-MP;
    • Anti TNF or anti-integrin therapy.
    10. For participants in the US and the EU: have had an inadequate response or intolerance to TNF inhibitors.
    11. Stable doses of the following therapies for UC for designated time and throughout study (Note: The following therapies for UC are not required, however allowed, and if taken, must remain stable for those subjects who are taking them at the time of enrollment):
    • Oral 5 ASA or sulfasalazine for at least 4 weeks prior to baseline.
    • Oral corticosteroids equivalent to prednisone </=1 mg/kg up to a maximum of 20 mg/day or budesonide up to 9 mg/day at least 2 weeks prior to baseline.
    12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    13. No contraception methods are required for male participants in this study, as the calculated safety margin is ≥100 fold between the estimated maternal exposure due to seminal transfer and the no observed adverse effect level (NOAEL) for serious manifestations of developmental toxicity in nonclinical studies.
    A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP) (see definitions in Section 4.3.4.1) OR
    Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), as described in Section 4.3.4.2, during the intervention period and for at least 12 weeks after the last dose of study intervention. If a highly effective method that is user dependent is chosen, a second effective method of contraception, as described in Section 4.3.4.2, must also be used. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    E.4Principal exclusion criteria
    1. Diagnosis of indeterminate colitis, isolated proctitis, microscopic colitis, infectious colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease.
    2. History of symptomatic obstructive intestinal strictures or active ostomy.
    3. History of colectomy, extensive small bowel resection (>100 cm) or short bowel syndrome. Participants hospitalized for UC related reason(s) within 2 weeks of baseline visit other than for standard of care monitoring/observation or performing baseline endoscopic procedure..
    4. Any factors or clinical characteristics potentially related to the risk of venous thromboembolism (see Section 7.2.3, Risk Factor Check for VTE) that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
    5. Participants who have previously received tofacitinib or another Janus Kinase inhibitor.
    6. Participants vaccinated or exposed to a live or attenuated vaccine:
    • Within the 6 weeks prior to the first dose of study drug; OR
    • Who are expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug.
    7.Participants receiving the following treatments:
    • AZA, 6 MP, methotrexate (MTX), or thioguanine within 2 weeks prior to baseline.
    • Infliximab therapy within 2 weeks prior to baseline unless an undetectable serum level has been documented following the last dose of infliximab therapy prior to baseline.
    • Adalimumab therapy within 4 weeks prior to baseline unless an undetectable serum level has been documented following the last dose of adalimumab therapy prior to baseline.
    • Golimumab therapy within 4 weeks prior to baseline unless an undetectable serum level has been documented following the last dose of golimumab therapy prior to baseline.
    • Ustekinumab therapy within 6 weeks prior to baseline unless an undetectable serum level has been documented following the last dose of ustekinumab therapy prior to baseline.
    • Interferon therapy within 8 weeks prior to baseline.
    • Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
    • Intravenous (IV) corticosteroids within 2 weeks prior to baseline.
    • Rectally administered formulations of corticosteroids or 5 ASA within 1 week of screening endoscopy.
    • Natalizumab within 1 year prior to baseline.
    • Vedolizumab therapy within 6 weeks prior to baseline unless an undetectable serum level has been documented following the last dose of vedolizumab therapy prior to baseline.
    8. Investigational drugs within 3 months of baseline. Other antiadhesion molecules within 5 half-lives prior to baseline unless an undetectable serum level has been documented following the last dose of other antiadhesion molecule therapy prior to baseline
    9. Participants previously receiving leukocyte apheresis including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
    10. Participants receiving prohibited concomitant medications, including moderate to potent CYP3A inducers or inhibitors (see Appendix 3) 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.
    11. Participants who require chronic and frequent use of antimotility agents for control of diarrhea (ie, diphenoxylate hydrochloride with atropine sulfate or loperamide).
    12. Participants with a history of bowel surgery, including cholecystectomy within 6 months prior to baseline. Participants with appendectomy within 3 months prior to baseline are excluded.
    13. Participants with significant trauma or major surgery within 4 weeks of screening visit.
    14. Participants with the following laboratory values at screening:
    • Hemoglobin level <9.0 g/dL.
    • An absolute white blood cell (WBC) count of <3.0 x 10^9/L (<3000/mm³) or absolute neutrophil count of <1.2 x 10^9/L (<1200/mm³) or absolute lymphocyte count of <0.75 x 10^9/L (<750/mm³).
    • Thrombocytopenia, as defined by a platelet count <100 x 10^9/L (<100,000/mm³).
    • Estimated Glomerular filtration rate (GFR) </=40 mL/min/1.73 m² . GFR will be calculated by the Central lab using the bedside Schwartz formula (see Appendix 4).
    • Total bilirubin, aspartate aminostransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal.
    Note: Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and are eligible for the study provided the direct bilirubin is </= upper limit of normal (ULN).
    15. Participants who have positive stool examinations for enteric pathogens, pathogenic ova or parasites, or C. difficile toxin at screening.

    Please refer to the section 4.2 Exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint(s):
    • Remission by central read Mayo score following 44 weeks in the maintenance phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 44 in the maintenance phase
    E.5.2Secondary end point(s)
    • response by Mayo score (Induction Week 8, Induction Week 16,
    Maintenance Week 44).
    • Remission by Mayo score with local and central read (induction Week
    8, induction Week 16), and with local read (maintenance week 44).
    • Change from baseline in Mayo score (induction Week 8, induction
    Week 16, maintenance Week 44).
    • Partial Mayo Score response over time.
    • Change from baseline in Partial Mayo scores over time.
    • Response/remission by PUCAI score over time.
    • Change from baseline in PUCAI score over time.
    • Endoscopic improvement (previously known as mucosal healing)
    (induction Week 8, induction Week 16, maintenance Week 44).
    • Endoscopic remission (induction Week 8, induction Week 16,
    maintenance Week 44).
    • Remission at maintenance week 44 (Mayo and PUCAI) and extension
    (PUCAI only) amongst participants who achieved remission at the end of
    Induction. Rectal bleeding subscore of 0 over time.
    • Time to flare (maintenance, extension)
    • Change from baseline in fecal calprotectin levels over time.
    • Change from baseline in high sensitivity C-reactiveprotein (hsCRP)
    levels over time.
    • Corticosteroid free remission Corticosteroid free remission by Partial
    Mayo Score over time.
    • Change from baseline in lymphocyte subset counts (induction Week 8,
    induction Week 16, maintenance Week 44; extension Month 24).
    • PK: plasma concentrations (baseline, induction Week 8, induction
    Week 16, maintenance Week 16, maintenance Week 44).
    • Evaluation of taste acceptability of tofacitinib oral solution, and
    acceptability of film-coated tablet, if applicable, (Week 2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    various timepoint for each secondary endpoint are defined within the endpoint
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Canada
    Israel
    Japan
    United States
    Finland
    France
    Poland
    Sweden
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    Hungary
    Slovakia
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 42
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 78
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children between 2 and 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 120
    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)
    Study drug may be continued at the discretion of patient’s medical team but in this case will not be supplied by Pfizer
    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 Decision2021-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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