Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials

Author:

Jairath V.12,Khanna R.34,Zou G. Y.35,Stitt L.3,Mosli M.346,Vandervoort M. K.3,D'Haens G.37,Sandborn W. J.38,Feagan B. G.345,Levesque B. G.38

Affiliation:

1. Translational Gastroenterology Unit; Nuffield Department of Medicine; University of Oxford; Oxford UK

2. Oxford Clinical Trials Research Unit; Oxford UK

3. Robarts Clinical Trials; University of Western Ontario; London ON Canada

4. Department of Medicine; University of Western Ontario; London ON Canada

5. Department of Epidemiology and Biostatistics; University of Western Ontario; London ON Canada

6. Department of Medicine; King Abdulaziz University; Jeddah Saudi Arabia

7. Inflammatory Bowel Disease Centre; Academic Medical Centre; Amsterdam The Netherlands

8. Division of Gastroenterology; University of California, San Diego; La Jolla CA USA

Funder

UK National Institute for Health Research

Publisher

Wiley

Subject

Pharmacology (medical),Gastroenterology,Hepatology

Reference19 articles.

1. A review of activity indices and efficacy endponts for clinical trials of medical therapy in adults with ulcerative colitis;D'Haens;Gastroenterology,2007

2. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study;Schroeder;N Engl J Med,1987

3. 5-Aminosalicylic acid enemas in treatment of distal ulcerative colitis and proctitis in Canada;Sutherland;Dig Dis Sci,1987

4. Infliximab induction and maintenance therapy for ulcerative colitis;Rutgeerts;N Engl J Med,2005

5. Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers;Zagadailov;Am Health Drug Benefit,2013

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