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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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) .
     
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    Summary
    EudraCT Number:2009-013223-37
    Sponsor's Protocol Code Number:A9391005
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-013223-37
    A.3Full title of the trial
    A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
    A.4.1Sponsor's protocol code numberA9391005
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 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 support
    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
    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 namePF-04171327
    D.3.2Product code PF-04171327
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-04171327
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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) No
    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.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 namePF-04171327
    D.3.2Product code PF-04171327
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-04171327
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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) No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.3Other descriptive nameDecortin®
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of PF-04171327 (high and low dose) compared to placebo as assessed by DAS28-4 (CRP) at Week 2
    E.2.2Secondary objectives of the trial
    To determine the efficacy of 5 mg prednisone compared to placebo as assessed by DAS28-4 (CRP) at Week 2.
    To assess the safety and tolerability of PF-04171327 and prednisone 5 mg when administered to RA patients for 2 weeks.
    To evaluate PF-00251802 pharmacokinetics and biomarker responses in RA patients.
    To evaluate the pharmacokinetics of MTX in the presence of PF 00251802.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Males and females ≥18 years of age.
    4. Subject should have RA (ACR criteria, 1987 revised criteria) with a minimum duration of 3 months and fulfilled 4/7 criteria for the diagnosis of RA.
    5. Subject must have minimum disease activity level of at least :
    ≥6 swollen joints and ≥6 tender joints at screening and baseline (28 joint count);
    CRP ≥0.7 mg/dL (≥7.0 mg/L) at screening.
    6. Has observed the following washout periods, if treated with any of the following therapies:
    4 weeks of the first dose:
    Biologics−anakinra (Kineret®), etanercept (Enbrel®).
    DMARDs−leflunomide (Arava®), auranofin (oral gold) injectible gold (aurothioglucose or aurothiomalate), sulfasalazine, d-penicillamine, minocycline, cyclosporine, and azathioprine.
    Note: In addition to a washout period of 4 weeks for leflunomide, one of the following elimination procedures must have been adhered to for a minimum of 11 days:
    cholestyramine at a dose of 8 grams 3 times daily for at least 24 hours, or
    activated powdered charcoal at a dosage of 50 grams 4 times a day for at least 24 hours.
    Experimental NSAIDs−any experimental non-selective NSAID or experimental selective NSAID (COX-2 inhibitor).
    Other−herbal medications, immunization with any live or live attenuated virus vaccination (eg, FluMist™).
    6 weeks of the first dose:
    Glucocorticoids by any route (oral, intra-articular, intramuscular or intravenous) that may result in significant systemic exposure.
    8 weeks of first dose:
    infliximab (Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®).
    12 weeks of first dose:
    abatacept (Orencia®)
    12 months of first dose:
    rituximab(Rituxan®) or other selective B lymphocyte depleting agents—however, a B lymphocyte count is recommended to consider the subject sufficiently washed off before treatment with study drug.
    7. Meet the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III.
    8. Subject must have been on MTX or allowed MTX-DMARD combination (eg, MTX + hydroxychloroquine or MTX+ chloroquine) for at least 3 months, and be on a stable dose of MTX for at least 6 weeks (8 weeks for antimalarials) prior to screening. In addition, MTX or allowed DMARD combination as well as any concomitant medication(s) dose will remain unchanged during treatment period. In addition:
    Subjects should not be removed from ongoing glucocorticoid therapy and complete a wash out period for the purpose of qualification for this study.
    9. Subject must be on a MTX of dose ≥7.5 mg weekly (po/sc/im) and ≤25 mg weekly unless documented intolerance requires a lower dose. MTX should be administered as a single dose for a minimum of 28 days prior to randomization. If the proportion of enrolled subjects receiving a parenteral formulation (sc or im) exceeds 10% of the total, the sponsor may at its discretion limit further subsequent enrollment to subjects receiving oral MTX.
    10. For subjects on chronic topical or inhaled glucocorticoids, the treatment must be stable for ≥4 weeks prior to entry and remain unchanged through the 2-week treatment period.
    11. If of childbearing potential, agrees that when sexually active, to use 2 effective contraceptive methods and abide by the timeframes as noted in the Contraception section of the Lifestyle Guidelines.
    12. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    13. No evidence or history of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    A negative QuantiFERON® -TB Gold In Tube test or, if unavailable, a Mantoux Purified Protein Derivative skin test using 5 tuberculin units per 0.1 mL (5 TU PPD) result of <5 mm of induration, performed within the 3 months prior to screening. [It is strongly recommended that patients with a history of Bacille Calmette Guérin (BCG) vaccination be tested with the QuantiFERON®-TB Gold In Tube test.];
    A chest radiograph taken within the 3 months prior to screening without changes suggestive of active TB infection.
    E.4Principal exclusion criteria
    1. Diagnosis of any other arthritidies (inflammatory or non-inflammatory) or chronic pain condition (fibromyalgia, neuropathy) that, in the opinion of the investigator would interfere with disease activity assessments.
    2. Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease, or any other condition which would make the subject unsuitable for the study.
    3. Any lymphoproliferative disorder, such as Epstein-Barr Virus (EBV), history of lymphoma, leukemia, myeloproliferative disorders, multiple myleoma or signs and symptoms suggestive of current lymphatic disease.
    4. Active TB or currently undergoing treatment for active or latent TB.
    5. Any solid malignancy that has been in remission for less than 10 years, excluding subjects with nonmetastic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, who are eligible immediately after adequate treatment.
    6. Blood dyscrasis including confirmed:
    Hemoglobin <9 g/dL or Hematocrit <30%;
    Absolute white blood cell (WBC) count <3.0 x 10 to the power 9/L;
    Absolute neutrophils count <1.2 x 10 to the power 9/L;
    Platelet count<100 x 10 to the power 9/L.
    7. Hepatic transaminase elevations (AST or ALT) >1.5 ULN, confirmed at the screening visit.
    8. Subject diagnosed with insulin dependent diabetes mellitus or poorly controlled noninsulin dependent diabetes mellitus (HgbA1c value of >7.0% [ADA recommendation of poorly controlled]).
    9. Drug or alcohol abuse with less than 6 months of continued abstinence prior to the screening visit.
    10. Clinically significant infections (those requiring hospitalization or requiring parenteral antimicrobial therapy) within 6 months of the screening visit.
    11. A body temperature of 38 degrees Celcius or higher at the baseline visit or a febrile illness within 14 days prior to the first dose.
    12. An infection with human immunodeficiency virus (HIV) or Hepatitis B or C.
    13. Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
    14. Significant trauma, blood loss or major surgery (involving anesthesia or respiratory assistance within 4 weeks of the screening visit).
    15. Bone fracture and/or immobility/immobilization within 3 months of the screening visit.
    16. A standard 12-lead ECG demonstrating a QTc>460 ms for males and QTc>480 ms for females or other clinically significant abnormality at the screening visit. If the QTc is greater than 460 ms (for males) or 480 ms (for females), the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject’s eligibility.
    17. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
    18. Blood donation of approximately 1 pint (500 mL) within 60 days of the screening visit.
    19. Subjects with a previous or current history of glaucoma or ocular herpetic infections.
    20. Subjects known to be glucocorticoid ‘non-reponders’ or with a previous history of intolerance or significant adverse effects with glucocorticoid therapy.
    21. Documented history of peptic ulcer disease within 5 years.
    22. Subjects requiring prohibited concomitant medications listed in Appendix 1. This listing includes CYP3A4 inhibitors, CYP3A4 inducers, selected CYP3A4 substrates and/or other medications.
    23. Female subject who is pregnant or lactating.
    24. Current household contact with children who have received varicella or oral polio vaccine within 8 weeks of the screening visit.
    25. 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.
    E.5 End points
    E.5.1Primary end point(s)
    DAS28-4 (CRP) at Week 2.
    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 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) 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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    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 months11
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days7
    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) Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 119
    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 Decision2009-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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