Clinical Trials in Rheumatoid Arthritis and Osteoarthritis
Designed to be a practical handbook on clinical trial management in these key therapeutic areas, 'Clinical Trials in Rheumatoid Arthritis and Osteoarthritis' is aimed at principal investigators pharmaceutical physicians and other pharmaceutical staff invo
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Series Editors Derek Pearson, BSc, PhD Joint Service Manager Medical Physics & Clinical Engineering Department Nottingham University Hospitals NHS Trust City Hospitals Campus Hucknall NG5 1PB UK Other Titles in This Series Clinical Trials in Osteoporosis (2nd Edition) Derek Pearson and Colin G. Miller Clinical Trials in Rheumatoid Arthritis and Osteoarthritis David M. Reid and Colin G. Miller
Colin G. Miller, PhD, FICR Senior Vice President Medical Affairs Bio-Imaging Technologies Inc. 826 Newtown-Yardley Road Newtown, PA 18940 USA
David M. Reid • Colin G. Miller Editors
Clinical Trials in Rheumatoid Arthritis and Osteoarthritis
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Editors David M. Reid, MBChB, MD, FRCP Department of Medicine and Therapeutics University of Aberdeen Aberdeen, UK
ISBN: 978-1-85233-874-9 DOI: 10.1007/978-1-84628-742-8
Colin G. Miller, BSc, PhD, FICR Bio-Imaging Technologies Inc. Newtown, PA, USA
e-ISBN: 978-1-84628-742-8
British Library Cataloguing in Publication Data Clinical trials in rheumatoid arthritis and osteoarthritis 1. Rheumatoid arthritis - Treatment 2. Osteoarthritis Treatment 3. Clinical trials I. Reid, David, 1951- II. Miller, Colin G., 1960616.7’22060724 ISBN-13: 9781852338749 Library of Congress Control Number: 2007937490 c 2008 Springer-Verlag London Limited Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publishers, or in the case of reprographic reproduction in accordance with the terms of licences issued by the Copyright Licensing Agency. Enquiries concerning reproduction outside those terms should be sent to the publishers. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore free for general use. Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature. Printed on acid-free paper 987654321 Springer Science+Business Media springer.com
Contents
Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David M. Reid and Colin G. Miller 2 Historical and Current Perspectives on Management of Osteoarthritis and Rheumatoid Arthritis . . . . . . . . . . . . . . . . . . . . . . . . . . Shirish Dubey and Adewale O. Adebajo
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3 Development of Biological Therapies for Inflammatory Arthritis . . . . . 37 Neil Basu 4 Study Design and End Points for Rheumatoid Arthritis Trials . . . . . . . 51 Pieter Geusens and Colin G. Miller 5
Study D
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