DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hereditary Periodic Fevers

Intervention: canakinumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

Summary

ThIS study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with HPF (Hereditary Periodic Fevers) compared to placebo.

Clinical Details

Official title: Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of participants with resolution of initial flare at time of the randomization and absence of new flares

Secondary outcome:

Percentage of participants who achieve Physician's global assessment < 2

Percentage of participantswith the serologic remission

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Patient's written informed consent (or parent's written informed

consent in case of pediatric patient) at screening - Male and female patients at least 2

years of age at the time of the screening visit. - Confirmed diagnosis and active flare at

randomization - CRP >10mg/L at randomization

Exclusion Criteria: - Use of the following therapies (within varying protocol defined

timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or

chlorambucil, any other investigational biologics - History of malignancy of any organ

system (other than localized basal cell carcinoma of the skin or in - situ cervical

cancer), treated or untreated - Significant medical diseases, including but not limited to

the following: a. History of organ transplantation b. Elevated liver enzymes ≥2x ULN d. Increase in total bilirubin e. Serious hepatic disorder (Child-Pugh scores B or C) f. Chronic Kidney Disease g. Thyroid disease h. Diagnosis of active peptic ulcer disease i.

Coagulopathy j. Significant CNS effects including vertigo and dizziness - Any conditions

or significant medical problems which immunecompromise the patient and/or places the

patient at unacceptable risk for immunomodulatory therapy - Live vaccinations within 3

months prior to the start of the trial, during the trial, and up to 3 months following the last dose

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

Novartis Investigative Site, Bruxelles 1200, Belgium; Recruiting

Novartis Investigative Site, Edegem 2650, Belgium; Recruiting

Novartis Investigative Site, Hasselt 3500, Belgium; Recruiting

Novartis Investigative Site, Leuven 3000, Belgium; Recruiting

Novartis Investigative Site, Liege 4000, Belgium; Recruiting

Novartis Investigative Site, Bron Cedex 69677, France; Recruiting

Novartis Investigative Site, Le Kremlin Bicetre 94275, France; Recruiting

Novartis Investigative Site, Nimes Cedex 30029, France; Recruiting

Novartis Investigative Site, Paris 75015, France; Recruiting

Novartis Investigative Site, Berlin 10117, Germany; Recruiting

Novartis Investigative Site, Berlin 13353, Germany; Recruiting

Novartis Investigative Site, Essen 45147, Germany; Not yet recruiting

Novartis Investigative Site, Hamburg 20246, Germany; Not yet recruiting

Novartis Investigative Site, Hamburg 22081, Germany; Recruiting

Novartis Investigative Site, Muenchen 80337, Germany; Recruiting

Novartis Investigative Site, München 80336, Germany; Recruiting

Novartis Investigative Site, St. Augustin 53757, Germany; Recruiting

Novartis Investigative Site, Tübingen 72076, Germany; Recruiting

Novartis Investigative Site, Athens 115 27, Greece; Withdrawn

Novartis Investigative Site, Thessaloniki 54642, Greece; Withdrawn

Novartis Investigative Site, Budapest 1094, Hungary; Recruiting

Novartis Investigative Site, Budapest 1023, Hungary; Recruiting

Novartis Investigative Site, Galway, Ireland; Not yet recruiting

Novartis Investigative Site, Haifa 31048, Israel; Recruiting

Novartis Investigative Site, Haifa 31096, Israel; Recruiting

Novartis Investigative Site, Jerusalem 91031, Israel; Recruiting

Novartis Investigative Site, Jerusalem 91120, Israel; Not yet recruiting

Novartis Investigative Site, Petach-Tikva 49202, Israel; Recruiting

Novartis Investigative Site, Napoli 80131, Italy; Not yet recruiting

Novartis Investigative Site, Nijmegen 6500 HB, Netherlands; Recruiting

Novartis Investigative Site, Utrecht 3508 GA, Netherlands; Not yet recruiting

Novartis Investigative Site, Moscow 115522, Russian Federation; Recruiting

Novartis Investigative Site, Moscow 119991, Russian Federation; Not yet recruiting

Novartis Investigative Site, Moskow 117198, Russian Federation; Recruiting

Novartis Investigative Site, Rostov on Don 344022, Russian Federation; Recruiting

Novartis Investigative Site, Saint-Petersburg 194100, Russian Federation; Not yet recruiting

Novartis Investigative Site, Samara 443070, Russian Federation; Not yet recruiting

Novartis Investigative Site, Madrid 28034, Spain; Recruiting

Novartis Investigative Site, Madrid 28046, Spain; Recruiting

Novartis Investigative Site, Lausanne 1011, Switzerland; Recruiting

Novartis Investigative Site, Ankara 06100, Turkey; Recruiting

Novartis Investigative Site, Istanbul 34093, Turkey; Recruiting

Novartis Investigative Site, Istanbul 34303, Turkey; Recruiting

Novartis Investigative Site, Leeds LS9 7TF, United Kingdom; Not yet recruiting

Novartis Investigative Site, London NW3 2QG, United Kingdom; Recruiting

Novartis Investigative Site, London WC1N 1EH, United Kingdom; Recruiting

Novartis Investigative Site, Sciacca, AG 92019, Italy; Not yet recruiting

Novartis Investigative Site, Calgary, Alberta T3B 6A8, Canada; Recruiting

Novartis Investigative Site, Oviedo, Asturias 33011, Spain; Not yet recruiting

Novartis Investigative Site, Brescia, BS 25123, Italy; Recruiting

Novartis Investigative Site, Esplugues de Llobregat, Barcelona 08950, Spain; Recruiting

Novartis Investigative Site, Vancouver, British Columbia, Canada; Recruiting

Novartis Investigative Site, Los Angeles, California 90027, United States; Not yet recruiting

Novartis Investigative Site, Barcelona, Catalunya 08035, Spain; Recruiting

Novartis Investigative Site, Valencia, Comunidad Valenciana 46026, Spain; Recruiting

Novartis Investigative Site, Firenze, FI 50139, Italy; Recruiting

Novartis Investigative Site, Fukuoka-city, Fukuoka 812-8582, Japan; Recruiting

Novartis Investigative Site, Genova, GE 16147, Italy; Recruiting

Novartis Investigative Site, Alexandroupolis, GR 68100, Greece; Withdrawn

Novartis Investigative Site, Yokohama-city, Kanagawa 236-0004, Japan; Recruiting

Novartis Investigative Site, Kyoto-city, Kyoto 606-8507, Japan; Recruiting

Novartis Investigative Site, Messina, ME 98125, Italy; Recruiting

Novartis Investigative Site, Bethesda, Maryland 20892, United States; Withdrawn

Novartis Investigative Site, Boston, Massachusetts 02115, United States; Not yet recruiting

Novartis Investigative Site, Ann Arbor, Michigan 48109, United States; Recruiting

Novartis Investigative Site, El Palmar, Murcia 30120, Spain; Recruiting

Novartis Investigative Site, Cleveland, Ohio 44195, United States; Recruiting

Novartis Investigative Site, Toronto, Ontario M5G 1X8, Canada; Withdrawn

Novartis Investigative Site, Padova, PD 35128, Italy; Withdrawn

Novartis Investigative Site, Pavia, PV 27100, Italy; Recruiting

Novartis Investigative Site, Philadelphia, Pennsylvania 19134-1095, United States; Not yet recruiting

Novartis Investigative Site, Roma, RM 00165, Italy; Recruiting

Novartis Investigative Site, Roma, RM 00168, Italy; Recruiting

Novartis Investigative Site, Trieste, TS 34137, Italy; Not yet recruiting

Additional Information

Starting date: June 2014
Last updated: November 24, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017