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    Summary
    EudraCT Number:2010-023782-22
    Sponsor's Protocol Code Number:A9391010
    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:2011-08-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-023782-22
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG
    Randomizované, dvojitě zaslepené klinické hodnocení fáze II hodnotící účinnost a bezpečnost PF-04171327 (denní dávka 1, 5, 10, 15 mg) ve srovnání s denní dávkou 5 mg a 10 mg prednisonu a s placebem u pacientů s revmatoidní artritidou po dobu 8 týdnů následovaných 4 týdny postupného snižování dávky hodnoceného léčivého přípravku
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG
    A.4.1Sponsor's protocol code numberA9391010
    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, 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 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
    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 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.3.2Product code PF-04171327
    D.3.4Pharmaceutical form 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 1044535-58-1
    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 number1
    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.3.2Product code PF-04171327
    D.3.4Pharmaceutical form 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 1044535-58-1
    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) 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: 3
    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.3.2Product code PF-04171327
    D.3.4Pharmaceutical form 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 1044535-58-1
    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) 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: 4
    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.2.1.1.1Trade name Decortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-02
    D.3.9.4EV Substance CodeSUB10020MIG
    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 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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10066578
    E.1.2Term Progression of rheumatoid arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare efficacy and safety of PF 04171327 (1, 5, 10 mg, 15 mg once daily) to 5 mg daily prednisone, 10 mg daily prednisone and placebo given over 8 weeks, in subjects with active RA on a stable background of MTX;

    Determine comparative therapeutic window of PF 04171327 using ACR 20 responses and change from baseline in P1NP and UNTx/uCr, (primary set of biomarkers) ie, determining a dose, or a range of doses, in which there is sufficient efficacy on the ACR20 and minor changes in P1NP and UNTx/uCr.
    E.2.2Secondary objectives of the trial
    To characterize the dose effect and concentration effects for efficacy, safety and biomarker outcome measures;

    To characterize the effects of PF 04171327 on the bone and carbohydrate biomarkers compared to prednisone 5 mg, 10 mg, and placebo;

    To examine the durability of the response to PF 04171327;

    To evaluate the tapering of PF 04171327;

    To evaluate the safety and tolerability of PF 04171327;

    To evaluate health and functional status of study subjects.
    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 legal 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. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    5. Women of child bearing potential must have a negative pregnancy test prior to nrollment in this study. Women are considered to be of child-bearing potential unless they are either post menopausal (documented by elevated FSH at screening), surgically sterile, or have had a hysterectomy and/or bilateral salpingo oophorectomy.
    6. If of child bearing potential, the subject 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.
    7. 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.
    8. 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.
    9. Meet the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III.
    10. Subject must have been on MTX or allowed MTX DMARD combination (eg, MTX + hydroxychloroquine or MTX + chloroquine or MTX + sulfasalazine) for at least 3 months, and be on a stable dose of MTX for at least 8 weeks prior to randomization. MTX or allowed DMARD combination, as well as any concomitant medication(s) dose, will remain unchanged during the treatment period.
    11. Subject must be on a stable MTX of dose ≤25 mg weekly (po/sc/IM). Stable MTX doses should be administered as a weekly single dose for a minimum of 8 weeks prior to randomization.
    12. For subjects on chronic topical or inhaled glucocorticoids, the treatment must be stable for ≥4 weeks prior to entry and remain unchanged throughout the study period.
    13. No evidence of active or latent 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 (PPD) 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;
    • No history of previously untreated infection with TB, and not currently receiving treatment for active TB;
    • A chest radiograph taken within the 3 months prior to screening without changes suggestive of active TB infection.
    • If a patient has a positive QFT Gold or PPD test, he/she may be eligible if he/she has completed an appropriate treatment regimen for TB and has a chest radiograph within the 3 months prior to Screening that shows no evidence of active TB. A subject who is currently being treated for latent TB infection can only be enrolled with documentation of an adequate treatment regimen, a chest radiograph within the 3 months prior to Screening that shows no evidence of active TB, and the approval by the Sponsor. In addition, patients must have maintained normal ALT and AST levels following initiation of treatment for latent TB (minimum of 1 month) duration of latent TB treatment prior to PF 04171327 dosing.
    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 conditions 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 myeloma or signs andsymptoms suggestive of current lymphatic disease. 4. A prior history of malignancy, excluding subjects with non-metastic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, who are eligible immediately after adequate treatment. 5. Blood dyscrasis including confirmed:Hemoglobin <9 g/dL or Hematocrit <30%; Absolute white blood cell (WBC) count <3.0 x 10 to the power of 9/L; Absolute neutrophils count <1.2 x 10 to the power of 9/L; Platelet count<100 x 10 to the power of 9/L. 6. Subjects treated with the following who did not observe the protocol specified wash out period before baseline: CYP3A4 inducers or inhibitors, Experimental NSAIDs,herbal medications, Immunization with any live or live attenuated virus vaccination (egg, FluMist™), Glucocorticoids by any route that may result in significant systemic exposure, Biologic DMARDs, Anakinra (Kineret®), etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Golimumab (Simponi TM), Abatacept (Orencia®), tocilizumab (Actemra), certolizumab pegol (Cimzia®), rituximab(Rituxan®) or other selective B lymphocyte depleting agents, DMARDs, d-penicillamine, azathioprine, cyclosporine, tacrolimus, and staphylococcal protein. Immuno-absorbant pheresis columns (eg, PROSORBA device/column), Tetracyclines, unless prescribed for the treatment of acne or other dermatologic disorders, Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold), Leflunomide (Arava®). 7. Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug. Patients cannot participate in other clinical studies at any time during their participation in this study. Prior exposure to investigational biologics should be discussed with the Pfizer Medical Monitor, as these agents may require extended washout periods.
    8. Hepatic enzyme elevations (ALT or ALP) >1.3 ULN. 9. Subject diagnosed with insulin dependent diabetes mellitus or poorly controlled noninsulin dependent diabetes mellitus (HgbA1c value of >8.0%). 10. Drug or alcohol abuse with less than 6 months of continued abstinence prior to the screening visit. 11. Clinically significant infections (those requiring hospitalization or requiring parenteral antimicrobial therapy) within 6 months of the screening visit. 12. A body temperature of 38◦C or higher at the baseline visit or a febrile illness within 14 days prior to the first dose. 13. An infection with human immunodeficiency virus (HIV) or Hepatitis B or C. 14. Any condition possibly affecting oral drug absorption 15. Significant trauma, blood loss or major surgery (involving anesthesia or respiratory assistance within 4 weeks of the screening visit). 16. Bone fracture and/or immobility/immobilization within 3 months of the screening visit. 17. A standard 12-lead ECG demonstrating a QTcF >450 ms for males and QTcF >480 ms for females or other clinically significant abnormality at the screening visit. If the QTcF is greater than 450 ms (for males) or 480 ms (for females), the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject’s eligibility. 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-responders’ 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. Ongoing treatment with an NSAID or selective COX inhibitor that is not stable (dose and duration) for at least six weeks prior to screening. 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 abnormalities 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)
    Efficacy: ACR20 at week 8;

    Primary set of dissociation biomarkers: P1NP, and UNTx/Ucr at week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Week 8
    E.5.2Secondary end point(s)
    Efficacy:
    ACR20 at 2, 4 and 12 weeks; ACR50, ACR70, Hybrid ACR response, Individual ACR components, all at Week 2, 4, 6, 8 &12;

    DAS 28 3 (CRP), DAS28 4 (CRP) at Week 2, 4, 6, 8 and 12;

    SF 36 v 2 (Quality of Life) at Week 4, 8, and 12.

    Pharmacokinetic and Pharmacodynamic endpoints:
    Plasma concentrations of PF 00251802 and its N Oxide metabolite PF 04015475 (baseline, Week 2, 4, 6, 8, 10 and 12);

    Pharmacodynamic effects will be assessed by several biomarkers, such as serum CTx, osteocalcin, P1NP, UNTx/UCr (baseline, Week 2, 4, 6, 8, 10, 12 and 13) and PTH and adiponectin (baseline, Week 4, 8, and 12).

    Safety endpoints:
    Biomarkers: plasma cortisol, CRP, will be obtained at baseline, Week 2, 4, 6, 8, 10, 12 and 13;

    Circulating lymphocytes, neutrophils, and eosinophil counts will be obtained at 4, 8 and 12 weeks;

    HbA1C (baseline Week 8 and 12), and fasting glucose at Week 0, 4, 8 and 12;

    Safety outcomes: Assessment of taper period, HPA axis labs (ACTH stimulation test (Week 13 after one week of study drug discontinuation), vital signs, telephone follow up (taper period), AE reports, routine labs (including liver tests), concomitant meds (esp. diabetes meds, glucocorticoids other than study drug).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Weeks 2, 4, 6, 8 and 12
    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 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 Yes
    E.8.2.3.1Comparator description
    Prednisone
    E.8.2.4Number of treatment arms in the trial7
    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 EEA50
    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
    Bulgaria
    Canada
    Colombia
    Czech Republic
    Germany
    Hungary
    India
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    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
    Last Subject Last Visit
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 200
    F.4.2.2In the whole clinical trial 315
    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)
    Patient care after the trial should be no different than the expected standard of care treatment for rheumatoid arthritis
    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 Decision2011-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-09
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