DOCSLIB.ORG

Prevalence of Celiac Disease: a Multicenter Trial in Pediatric Population from Five Urban Districts of Argentina

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Prevalence of Celiac Disease: a Multicenter Trial in Pediatric Population from Five Urban Districts of Argentina Original article Arch Argent Pediatr 2012;110(6):490-495 / 490 Prevalence of celiac disease: a multicenter trial in pediatric population from five urban districts of Argentina Mabel Mora, MDa, Néstor Litwin, MDb, María del Carmen Toca, MDc, María Inés Azcona, MDa, Rossana Solís Neffa, MDa, Fernando Battiston, MDa, María Solaegui, MDa, Gonzalo Ortiz, MDc, Marta Wagener, MDd, Jorgelina Olivera, MDd, Silvia Marchisone, MDe, Gabriela Oropeza, MDe, Cinthia Bastianelli, MDf, Alejandra González, MDg and Gabriela Rezzónico, MDh SUMMARY sequence of an inflammatory response Introduction. No published material on the to the intake of gluten in genetically preva lence of celiac disease (CD) in the pedi- atric popula tion of Argentina has been found susceptible indi viduals. up to date. Its clinical spectrum is varied and Objec tive. To estimate the prevalence of CD in includes three forms: classical, with a pediatric population (hospital-based sample) mal absorption syndrome, silent and from 5 urban districts of Argentina. Methods. In a cross-sectional descriptive study, atypical. Extraintestinal –often oligo- we analyzed serum samples from 2219 children, symptomatic– manifestations can also a. Hospital Materno aged 3-16 years old, which had been requested Infantil de San be observed in atypical celiac disease, for pre-surgical tests and for physical aptitude Isidro “Dr. Carlos such as short stature, osteoporosis, certificates for sports in the province of Buenos Gianantonio”. Aires, and cit ies of Buenos Aires, Córdoba, Santa anemia, abortions, in fertility, epilepsy, b. Gastroenterology Fe and Salta. Children with a previous and ac- ataxia, occipital cerebral calcifications, Research Laboratory. curate diagnosis of CD were also included. IgA c. Hospital Nacional recurrent aphthous ulcers or dermati- class tissue transglu taminase antibodies were 1-3 “Prof. A. Posadas”. tis herpetiformis. determined using serum samples, and those Province of Buenos samples which turned out posi tive were also If any of these occur, the early Aires. tested for IgA class endomysium antibodies. A diagno sis of celiac disease should be d. Hospital de Niños small intestine biopsy was proposed for those 4-6 de Santa Fe considered to avoid complications. who had a positive serology. “Dr. O. Alassia”. There are conditions associated to ce- Results. Between May 2008 and August 2009, e. Hospital Municipal 29 positive serologies were found. A total of liac disease, such as Down, Williams, Infantil de Córdoba. 22 duo denum biopsies were performed, and 21 Turner syndromes, and autoimmune f. Hospital “Niño Jesús turned out compatible with CD. Out of 2219 chil- de Praga”. Salta. disorders, such as type 1 diabetes, dren, 7 had a previous diagnosis. A prevalence g. Hospital Universitario Hashimoto’s thyroiditis or autoim- of 1.26% (1:79 children), with female gender pre- CEMIC. 7,8 dominance (p < 0.023) was found. mune hepatitis, among others. Buenos Aires. Ninety percent of the celiac children were over The so-called silent celiac patients h. Clínica San Lucas. 6 years old (p < 0.021). Silent celiac disease pre- San Isidro. Province present no clinic manifestation and, dominated but there was a 33% of symptom- of Buenos Aires. while they are most common in the atic cases. Conclusions. The results of the trial show a so-called risk groups, they can also be E­mail Address: higher prevalence of CD than expected. The found among the general population. Mabel Mora, MD: finding of symptomatic patients (33%) suggests [email protected] Risk groups are composed by those the undertak ing of different activities to spread who have family members with celiac the knowledge on this disease and promote the Funding: indication for serology test, to avoid complica- disease or associated conditions. Ramon Carrillo- tions by means of an early diagnosis. The clinical spectrum of this disease Arturo Oñativia Key words: celiac disease, prevalence, children, tis­ Initiation Scholarship has been compared to an iceberg, in sue transglutaminase, Argentina. granted by the Health which the symptomatic form is the vis- Research Committee http://dx.doi.org/10.5546/aap.2012.490 ible part, while the atypical and silent (Comité Nacional forms, almost seven times more fre- Salud Investiga) of the 9 Ministry of Health. quent, constitute the submerged part. INTRODUCTION In the 1980s, serological determina- Conflict of Interest: Celiac disease is a permanent tions, such as antigliadin, started None. condition of gluten intolerance, char- being performed, spreading the Received: 2-12-2012 acterized by damage to the mucous of knowledge on this clinical spectrum. Accepted: 6-22-2012 the small intestine, produced as a con- Subsequently, other antibodies of Prevalence of celiac disease: a multicenter trial in pediatric population from five urban districts of Argentina / 491 greater specific ity and sensitivity appeared, such hospital centers of the City of Buenos Aires and as anti-endomysi um (EMA) and tissue transgluta- its suburbs, and the City of La Plata, on the pop- minase (tTG). EMA showed a 96% sensitivity and ulation estimated for that area.21 In 1999, a popu- a specificity close to 100%, while tTG has a 95-99% lation-based study was conducted on premarital specificity and a 96% sensitivity in children. The serum samples in the area of La Plata, and a great- technique for the latter is simpler, and therefore er prevalence (1:167) was found.22 it is used as the method of choice in population Pediatric studies are scarce. In Finland (2003), studies.10 a prevalence of 1:99 was found in schoolchil- The diagnosis of celiac disease is confirmed dren,23 and in Hungary (1999), this was of 1:85.24 through a small intestine biopsy. The symptoms, In Argentina, up to date, no population-based pos itive antibodies and intestinal damage are re- stud ies have been published on the prevalence in versible with a gluten-free diet. pediatric population. Assessing the magnitude of celiac disease re- According to the 2001 Census, Argentina has quires knowledge of all its clinical manifestations, a predominantly urban distribution of the popu- especially those hidden, for which a prevalence lation (89%).25 study in general population is the most important source of information. OBJECTIVE In the literature there are three modalities of To estimate the prevalence of celiac disease in preva lence studies, given the clinical characteris- a pediatric population from 5 urban areas of the tics of ce liac disease: Central and Northern regions of Argentina, and to 1. Diagnosed cases of celiac disease on popula- analyze their clinical manifestations, distribution tion density in a determined area. These re- per sex, age group and geographic distribution. present the first epidemiological studies, prior to the use of serology; cases were generally METHODS symptomatic, clas sical and their prevalence A cross-sectional descriptive design was was lower. For instance, in 1950, in England used. The population was made of children aged and Wales, the prevalence of celiac disease 3-16 years old, who attended health-care facilities was estimated at 1 every 8000 in dividuals.11 of five urban dis tricts of the country to have pre- Subsequent studies were conducted in Italy as surgical tests for sched uled or emergency surger- from 1990, with the first use of serology. ies or fitness tests for sports. We worked with a 2. Studies of celiac disease cases in risk popula- consecutive sample. Children com ing from Gas- tions (family members and patients with asso- troenterology, Endocrinology, Rheuma tology or ciated con ditions), and their prevalence was that could suffer a pathology related to celiac dis- higher. Fasano et al., found a prevalence of ease were expressly excluded. 1:22 among family members of patients with The optimal situation would have been to in- celiac disease.12 clude children from a general population, but it 3. Population-based studies: they are conducted would have been more difficult to justify the col- in general population. This study is perfor- lection of blood among study participants. For this med under this modality. This research revea- reason, we decid ed to include such population, led a prevalence of the disease much higher given that none of the surgical indications would than expected. Sero logic studies in blood do- have relation to celiac disease, and also consider- nors in Sweden in 1991 showed a prevalence ing an appropriate and possible population for the of 1:256.13 Other similar stud ies indicated the objective of the research study. The children had following results: 1:250 in the USA,14 1:330 in to be Argentineans, with at least one Ar gentinean the Netherlands,15 1:99 in Finland,16 and 1:157 parent, so as to minimize the influence of na tive in Israel.17 In Mexico a high prevalence of tTG populations from other countries. We also includ- positivity was found in blood donors (1:37).18 ed those with a previous and accurate diagnosis of In Brazil, a study in Sao Pablo showed a prev- celiac disease within that population. alence of 1:273, and another in Brasilia of The informed consent of at least one of the 1:681.19,20 parents was obtained. Under the described modality, a study was Seven sites participated: Hospital Materno published in 1993 in Argentina showing a prev- Infan til de San Isidro, Clínica San Lucas de San alence of 1:1377 in children. The study was con- Isidro and Hospital Nacional Prof. Dr. A. Posa- ducted using the number of cases diagnosed in das (Greater Bue nos Aires), CEMIC of the City of 492 / Arch Argent Pediatr 2012;110(6):490-495 / Original article Buenos Aires, Hospi tal Infantil of Córdoba, Hos- The average age (mean) of the population pital de Niños de Salta and Hospital de Niños de studied was of 8 years and 5 months, with a mean Santa Fe.
Load more

Recommended publications
  • Contemporary Clinical Trials Communications 16 (2019) 100488
    Contemporary Clinical Trials Communications 16 (2019) 100488 Contents lists available at ScienceDirect Contemporary Clinical Trials Communications journal homepage: http://www.elsevier.com/locate/conctc Opinion paper Creating an academic research organization to efficiently design, conduct, coordinate, and analyze clinical trials: The Center for Clinical Trials & Data Coordination Kaleab Z. Abebe *, Andrew D. Althouse, Diane Comer, Kyle Holleran, Glory Koerbel, Jason Kojtek, Joseph Weiss, Susan Spillane Center for Clinical Trials & Data Coordination, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA ARTICLE INFO ABSTRACT Keywords: When properly executed, the randomized controlled trial is one of the best vehicles for assessing the effectiveness Data coordinating center of one or more interventions. However, numerous challenges may emerge in the areas of study startup, Clinical trial management recruitment, data quality, cost, and reporting of results. The use of well-run coordinating centers could help prevent these issues, but very little exists in the literature describing their creation or the guiding principles behind their inception. The Center for Clinical Trials & Data Coordination (CCDC) was established in 2015 through institutional funds with the intent of 1) providing relevant expertise in clinical trial design, conduct, coordination, and analysis; 2) advancing the careers of clinical investigators and CCDC-affiliated faculty; and 3) obtaining large data coordi­ nating center (DCC) grants. We describe the organizational structure of the CCDC as well as the homegrown clinical trial management system integrating nine crucial elements: electronic data capture, eligibility and randomization, drug and external data tracking, safety reporting, outcome adjudication, data and safety moni­ toring, statistical analysis and reporting, data sharing, and regulatory compliance.
    [Show full text]
  • Adaptive Enrichment Designs in Clinical Trials
    Annual Review of Statistics and Its Application Adaptive Enrichment Designs in Clinical Trials Peter F. Thall Department of Biostatistics, M.D. Anderson Cancer Center, University of Texas, Houston, Texas 77030, USA; email: [email protected] Annu. Rev. Stat. Appl. 2021. 8:393–411 Keywords The Annual Review of Statistics and Its Application is adaptive signature design, Bayesian design, biomarker, clinical trial, group online at statistics.annualreviews.org sequential design, precision medicine, subset selection, targeted therapy, https://doi.org/10.1146/annurev-statistics-040720- variable selection 032818 Copyright © 2021 by Annual Reviews. Abstract All rights reserved Adaptive enrichment designs for clinical trials may include rules that use in- terim data to identify treatment-sensitive patient subgroups, select or com- pare treatments, or change entry criteria. A common setting is a trial to Annu. Rev. Stat. Appl. 2021.8:393-411. Downloaded from www.annualreviews.org compare a new biologically targeted agent to standard therapy. An enrich- ment design’s structure depends on its goals, how it accounts for patient heterogeneity and treatment effects, and practical constraints. This article Access provided by University of Texas - M.D. Anderson Cancer Center on 03/10/21. For personal use only. first covers basic concepts, including treatment-biomarker interaction, pre- cision medicine, selection bias, and sequentially adaptive decision making, and briefly describes some different types of enrichment. Numerical illus- trations are provided for qualitatively different cases involving treatment- biomarker interactions. Reviews are given of adaptive signature designs; a Bayesian design that uses a random partition to identify treatment-sensitive biomarker subgroups and assign treatments; and designs that enrich superior treatment sample sizes overall or within subgroups, make subgroup-specific decisions, or include outcome-adaptive randomization.
    [Show full text]
  • The Α7 Nicotinic Agonist ABT-126 in the Treatment
    Neuropsychopharmacology (2016) 41, 2893–2902 © 2016 American College of Neuropsychopharmacology. All rights reserved 0893-133X/16 www.neuropsychopharmacology.org The ɑ7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study ,1 1 1,2 1 George Haig* , Deli Wang , Ahmed A Othman and Jun Zhao 1 2 Abbvie Inc., North Chicago, IL, USA; Faculty of Pharmacy, Cairo University, Cairo, Egypt A double-blind, placebo-controlled, parallel-group, 24-week, multicenter trial was conducted to evaluate the efficacy and safety of 3 doses of ABT-126, an α7 nicotinic receptor agonist, for the treatment of cognitive impairment in nonsmoking subjects with schizophrenia. Clinically stable subjects were randomized in 2 stages: placebo, ABT-126 25 mg, 50 mg or 75 mg once daily (stage 1) and placebo or ABT-126 50 mg (stage 2). The primary analysis was the change from baseline to week 12 on the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score for ABT-126 50 mg vs placebo using a mixed-model for repeated-measures. A key secondary measure was the University of California Performance-based Assessment-Extended Range (UPSA-2ER). A total of 432 subjects were randomized and 80% (344/431) completed the study. No statistically significant differences were observed in either the change from baseline for the MCCB neurocognitive composite score (+2.66 [ ± 0.54] for ABT-126 50 mg vs +2.46 [ ± 0.56] for placebo at week 12; P40.05) or the UPSA-2ER. A trend for improvement was seen at week 24 on the 16-item Negative Symptom Assessment Scale total − ± − ± = score for ABT-126 50 mg (change from baseline 4.27 [0.58] vs 3.00 [0.60] for placebo; P 0.059).
    [Show full text]
  • Downloadable Database from January 1 to October 21, 2020
    medRxiv preprint doi: https://doi.org/10.1101/2020.11.29.20237875; this version posted November 30, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license . CLINICAL TRIALS IN COVID-19 MANAGEMENT & PREVENTION: A META-EPIDEMIOLOGICAL STUDY EXAMINING METHODOLOGICAL QUALITY Authors: Kimia Honarmand MD MSc1, Jeremy Penn BHSc (c)2, Arnav Agarwal3,4, Reed Siemieniuk3, Romina Brignardello- Petersen3, Jessica J Bartoszko3, Dena Zeraatkar3,5, Thomas Agoritsas3,6, Karen Burns3,7, Shannon M. Fernando MD MSc8, Farid Foroutan9, Long Ge PhD10, Francois Lamontagne11, Mario A Jimenez-Mora MD12, Srinivas Murthy13, Juan Jose Yepes Nuñez12,14 MD, MSc, PhD, Per O Vandvik MD, Ph.D15, Zhikang Ye3, Bram Rochwerg MD MSc3,16 Affiliations: 1. Division of Critical Care, Department of Medicine, Western University, London, Canada 2. Faculty of Health Sciences, McMaster University, Hamilton, Canada 3. Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada 4. Department of Medicine, University of Toronto, Toronto, Canada 5. Department of Biomedical Informatics, Harvard Medical School, Boston, USA 6. Division General Internal Medicine, University Hospitals of Geneva, Geneva, Switzerland 7. Unity Health Toronto, St. Michael’s Hospital, Li Ka Shing Knowledge Institute, Toronto, Canada 8. Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, Canada 9. Ted Rogers Centre for Heart Research, University Health Network, Toronto General Hospital, Toronto, Canada 10. Evidence Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou, Gansu, China 11.
    [Show full text]
  • Exploring the Application of a Multicenter Study Design in the Preclinical Phase of Translational Research
    Exploring the Application of a Multicenter Study Design in the Preclinical Phase of Translational Research Victoria Hunniford Thesis submitted to the University of Ottawa in partial Fulfillment of the requirements for the Master of Science in Health Systems Telfer School of Management University of Ottawa © Victoria Hunniford, Ottawa, Canada, 2019 Abstract Multicenter preclinical studies have been suggested as a method to improve potential clinical translation of preclinical work by testing reproducibility and generalizability of findings. In these studies, multiple independent laboratories collaboratively conduct a research experiment using a shared protocol. The use of a multicenter design in preclinical experimentation is a recent approach and only a handful of these studies have been published. In this thesis, I aimed to provide insight into preclinical multicenter studies by 1) systematically synthesizing all published preclinical multicenter studies; and 2) exploring the experiences of, barriers and enablers to, and the extent of collaboration within preclinical multicenter studies. In Part One, I conducted a systematic review of preclinical multicenter studies. The database searches identified 3150 citations and 13 studies met inclusion criteria. The multicenter design was applied across a diverse range of diseases including stroke, heart attack, and traumatic brain injury. The median number of centers was 4 (range 2-6) and the median sample size was 133 (range 23-384). Most studies had lower risk of bias and higher completeness of reporting than typically seen in single-centered studies. Only five of the thirteen studies produced results consistent with previous single-center studies, highlighting a central concern of preclinical research: irreproducibility and poor generalizability of findings from single laboratories.
    [Show full text]
  • E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
    E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2018 Procedural OMB Control No. 0910-0843 Expiration Date 09/30/2020 See additional PRA statement in section 9 of this guidance. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 885-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: [email protected] http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: [email protected] http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2018 Procedural Contains Nonbinding Recommendations TABLE OF CONTENTS INTRODUCTION ...............................................................................................................
    [Show full text]
  • Labelling Requirements for Investigational Medicinal Products in Multinational Clinical Trials: Bureaucratic Cost Driver Or Added Value?
    Labelling Requirements for Investigational Medicinal Products in Multinational Clinical Trials: Bureaucratic Cost Driver or Added Value? Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels „Master of Drug Regulatory Affairs“ der Mathematisch-Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von Dr. Astrid Weyermann aus Herford Bonn 2006 Dr. Astrid Weyermann Labelling requirements for IMPs in multinational CTs Betreuer und 1. Referent: H. Jopp Zweiter Referent: Dr. J. Hofer Page 2 / 71 Dr. Astrid Weyermann Labelling requirements for IMPs in multinational CTs TABLE OF CONTENTS TABLE OF CONTENTS .......................................................................................................................... 3 1 EXECUTIVE SUMMARY.................................................................................................................. 6 2 INTRODUCTION.............................................................................................................................. 7 2.1 Definitions ..................................................................................................................................... 7 2.2 Clinical Trials ................................................................................................................................ 8 2.2.1 Types of clinical trials ............................................................................................................ 8 2.2.1.1 Phases of Clinical Trials ...................................................................................................
    [Show full text]
  • Study Protocol, but May Have Been Done Outside of the Study Protocol by the Subject’S Provider
    A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis DMID Protocol Number: 12-0021 DMID Funding Mechanism: VTEU Contract Support Pharmaceutical Support Provided by: Hennepin Life Sciences Other Identifying Numbers: None IND Sponsor: Division of Microbiology and Infectious Diseases The National Institute of Allergy and Infectious Diseases The National Institutes of Health Principal Investigator: Patricia Winokur, MD DMID Clinical Project Manager: Barbara Hahn, RN, BSN DMID Medical Monitor: Soju Chang, MD Version 8 23 May 2017 1 DMID Protocol No. 12-0021 Version 8.0 23May2017 STATEMENT OF COMPLIANCE This trial will be conducted in compliance with the protocol, International Conference on Harmonisation guideline E6: Good Clinical Practice: Consolidated Guideline, the applicable regulatory requirements from US Code of Federal Regulations (CFR) (Title 45 CFR Part 46 and Title 21 CFR including Parts 50 and 56) concerning informed consent and Institutional Review Board regulations, and the NIAID Clinical Terms of Award. All individuals responsible for the design and conduct of this study have completed Human Subjects Protection Training and are qualified to be conducting this research prior to the enrollment of any subjects. Curricula vitae for all investigators and sub-investigators participating in this trial are on file in a central facility (21 CFR 312.23 [a] [6] [iii] [b] edition). 2 DMID Protocol No. 12-0021 Version 8.0 23May2017 SIGNATURE PAGE The signature below constitutes the approval of this protocol and the attachments, and provides the necessary assurances that this trial will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, and according to local legal and regulatory requirements and applicable US federal regulations and ICH guidelines.
    [Show full text]
  • A Multicenter, Adaptive, Randomized Blinded Controlled Trial of The
    A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults Short Title: Adaptive COVID-19 Treatment Trial (ACTT) DMID Protocol Number: 20-0006 Sponsor: Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases, National Institutes of Health Version Number: 6.0 25 May 2020 DMID/NIAID/NIH CONFIDENTIAL Page 1 of 146 Protocol 20-0006 Version 6.0 Adaptive COVID-19 Treatment Trial (ACTT) 25 May 2020 Main protocol document STATEMENT OF COMPLIANCE Each institution engaged in this research will hold a current Federalwide Assurance (FWA) issued by the Office of Human Research Protection (OHRP) for federally funded research. The Institutional Review Board (IRB)/Independent or Institutional Ethics Committee (IEC) must be registered with OHRP as applicable to the research. The study will be carried out in accordance with the following as applicable: • All National and Local Regulations and Guidance applicable at each site • The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6(R2) Good Clinical Practice, and the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • United States (US) Code of Federal Regulations (CFR) 45 CFR Part 46: Protection of Human Subjects
    [Show full text]
  • Study Protocol
    Adalimumab M15-573 Protocol NCT02904902 1.0 Title Page Clinical Study Protocol M15-573 A Phase 3 Multicenter, Open-Label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects with Moderate to Severe Hidradenitis Suppurativa AbbVie Investigational Product: Adalimumab Date: 07 July 2016 Development Phase: 3 Study Design: Non-randomized, Open-label, Single-arm EudraCT Number: N/A Investigators: Multicenter Trial (Investigator information on file at AbbVie) Sponsor: AbbVie GK, Sponsor/Emergency Contact: This study will be conducted in compliance with the protocol, Good Clinical Practice and all other applicable regulatory requirements, including the archiving of essential documents. Confidential Information No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie. 1 Adalimumab M15-573 Protocol 1.1 Synopsis AbbVie Inc. Protocol Number: M15-573 Name of Study Drug: Adalimumab Phase of Development: 3 Name of Active Ingredient: Adalimumab Date of Protocol Synopsis: 07 July 2016 Protocol Title: A Phase 3 Multicenter, Open-Label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects with Moderate to Severe Hidradenitis Suppurativa Objective: The primary objective of this study is to evaluate the safety and efficacy of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS). Investigators: Multicenter Study Sites: Approximately 10 centers. Study Population: Male or female Japanese subjects age 18 years or older with moderate to severe HS. Number of Subjects to be Enrolled: Approximately 15 Methodology: This study is an open-label, single arm study designed to investigate the safety and efficacy of adalimumab in Japanese patients with moderate to severe hidradenitis suppurativa after 12 weeks of treatment, and to evaluate long-term safety, efficacy and tolerability.
    [Show full text]
  • IDSA/ATS Consensus Guidelines on The
    SUPPLEMENT ARTICLE Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults Lionel A. Mandell,1,a Richard G. Wunderink,2,a Antonio Anzueto,3,4 John G. Bartlett,7 G. Douglas Campbell,8 Nathan C. Dean,9,10 Scott F. Dowell,11 Thomas M. File, Jr.12,13 Daniel M. Musher,5,6 Michael S. Niederman,14,15 Antonio Torres,16 and Cynthia G. Whitney11 1McMaster University Medical School, Hamilton, Ontario, Canada; 2Northwestern University Feinberg School of Medicine, Chicago, Illinois; 3University of Texas Health Science Center and 4South Texas Veterans Health Care System, San Antonio, and 5Michael E. DeBakey Veterans Affairs Medical Center and 6Baylor College of Medicine, Houston, Texas; 7Johns Hopkins University School of Medicine, Baltimore, Maryland; 8Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi School of Medicine, Jackson; 9Division of Pulmonary and Critical Care Medicine, LDS Hospital, and 10University of Utah, Salt Lake City, Utah; 11Centers for Disease Control and Prevention, Atlanta, Georgia; 12Northeastern Ohio Universities College of Medicine, Rootstown, and 13Summa Health System, Akron, Ohio; 14State University of New York at Stony Brook, Stony Brook, and 15Department of Medicine, Winthrop University Hospital, Mineola, New York; and 16Cap de Servei de Pneumologia i Alle`rgia Respirato`ria, Institut Clı´nic del To`rax, Hospital Clı´nic de Barcelona, Facultat de Medicina, Universitat de Barcelona, Institut d’Investigacions Biome`diques August Pi i Sunyer, CIBER CB06/06/0028, Barcelona, Spain. EXECUTIVE SUMMARY priate starting point for consultation by specialists. Substantial overlap exists among the patients whom Improving the care of adult patients with community- these guidelines address and those discussed in the re- acquired pneumonia (CAP) has been the focus of many cently published guidelines for health care–associated different organizations, and several have developed pneumonia (HCAP).
    [Show full text]
  • A Systematic Review and Meta-Analysis of Clinical Trials on Physical Interventions for Lateral Epicondylalgia
    411 REVIEW A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia L Bisset, A Paungmali, B Vicenzino, E Beller ............................................................................................................................... Br J Sports Med 2005;39:411–422. doi: 10.1136/bjsm.2004.016170 A systematic review of the literature on the effectiveness of to May 1999), and non-steroidal anti-inflamma- tory drugs (NSAIDs; databases searched to June physical interventions for lateral epicondylalgia (tennis 2001).11–14 Another systematic review (databases elbow) was carried out. Seventy six randomised controlled searched to June 2002) within the Cochrane trials were identified, 28 of which satisfied the minimum Library has looked at the effectiveness of transverse friction massage on general tendino- criteria for meta-analysis. The evidence suggests that pathy conditions.15 The prevailing conclusion extracorporeal shock wave therapy is not beneficial in the drawn by many of these reviews was that of treatment of tennis elbow. There is a lack of evidence for insufficient evidence to support any one treat- ment over another, predominantly because of the the long term benefit of physical interventions in general. low statistical power, inadequate internal validity, However, further research with long term follow up into and insufficient data reported in most of the trials. manipulation and exercise as treatments is indicated. Before the systematic review of Smidt et al,10 there was
    [Show full text]