Updating the 2003 European regulatory requirements for registering disease-modifying drugs to be used in the treatment of rheumatoid arthritis

Rheumatology

Volumn 50, Issue 10, 2011, Pages 1732-1736

  Smolen, Josef S ^a,b   Boers, Maarten ^c   Abadie, Eric C ^d   Breedveld, Ferdinand C ^e   Emery, Paul ^f,g   Bardin, Thomas ^h   Goel, Niti ⁱ   Ethgen, Dominique J ^j   Avouac, Bernard P ^k   Durez, Patrick ^l   Flamion, Bruno ^m   Laslop, Andrea ⁿ   Miossec, Pierre ^o   Reiter, Susanne ^p   Reginster, Jean Yves ^q  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Hietzing Hospital   (Austria)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^d AFSSAPS   (France)

^e LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^f UNIVERSITY OF LEEDS   (United Kingdom)

^g CHAPEL ALLERTON HOSPITAL   (United Kingdom)

^h HÔPITAL LARIBOISIÈRE   (France)

ⁱ UCB PHARMA   (Belgium)

^j MEDIMMUNE   (United States)

^k HENRI MONDOR HOSPITAL   (France)

^l CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^m UNIVERSITY OF NAMUR   (Belgium)

ⁿ AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY   (Austria)

^o UNIVERSITÉ DE LYON   (France)

^p Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^q University of Liege and CHU Centre Ville ^*  (Belgium)

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Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR INHIBITOR;

CLINICAL PROTOCOL; CONSENSUS DEVELOPMENT; DRUG APPROVAL; DRUG CHOICE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG RESEARCH; DRUG SAFETY; DRUG TREATMENT FAILURE; ECHOGRAPHY; EDITORIAL; FUNCTIONAL ASSESSMENT; GOLD STANDARD; JOINT RADIOGRAPHY; MEDICAL DOCUMENTATION; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RHEUMATOID ARTHRITIS; SAMPLE; SAMPLE SIZE; STUDY DESIGN; TREATMENT RESPONSE;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CLINICAL TRIALS AS TOPIC; CONSENSUS; CONTROL GROUPS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; EUROPE; HUMANS;

EID: 80052443205     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/keq413     Document Type: Editorial

References (20)

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