CLINICAL STUDY PROTOCOL COmparison of the effect of treatment with NSAIDs added to anti- TNF therapy versus anti-TNF therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis: a randomized controlled multicentre trial (CONSUL) Protocol number: CONSUL2016 Protocol version: 1.3 including Amendment No. 1 Date: 13.02.2017 EudraCT Number: 2016‐000615‐33 Investigational Products: Golimumab, Celecoxib Study Phase: phase IV Study Design: randomized, controlled, prospective, open-label, multicentrestudy Sponsor: Charité Universitätsmedizin Berlin Charitéplatz 1 10117 Berlin, Germany Coordinating Investigator: Prof. Dr. med. Denis Poddubnyy Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie Campus Benjamin Franklin Charité Universitätsmedizin Berlin Hindenburgdamm 30 12203 Berlin, Germany Tel: +49 30 8445-2302 or 450-514544 Fax: +49 30 8445-4149 Email:
[email protected] Study Physician: Dr. med. Burkhard Muche -same address- Tel. +49 (30) 8445-4144 Email:
[email protected] 4. CONSUL_Protocol_Version_1.3_with_Amendment_1_13.02.2017_clear.docx Page 1 of 61 TABLE OF CONTENT 1 LIST OF ABBREVIATIONS ................................................................................................. 4 2 PROTOCOL SYNOPSIS ..................................................................................................... 6 3 ASSESSMENT SCHEDULE .............................................................................................. 13 4 INTRODUCTION