Defining the optimal response criteria for the Crohn's disease activity index for induction studies in patients with mildly to moderately active Crohn's disease

American Journal of Gastroenterology

Volumn 103, Issue 12, 2008, Pages 3123-3131

  Thia, Kelvin T ^a   Sandborn, William J ^a   Lewis, James D ^b   Loftus Jr , Edward V ^a   Feagan, Brian G ^c   Steinhart, A Hillary ^d   Hanauer, Stephen B ^e   Persson, Tore ^f   Sands, Bruce E ^g  

^a MAYO CLINIC   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c ROBARTS RESEARCH INSTITUTE   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

^e UNIVERSITY OF CHICAGO   (United States)

^f ASTRAZENECA R AND D   (Sweden)

^g MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; DIPHENOXYLATE; LOPERAMIDE; MESALAZINE; PLACEBO; PREDNISOLONE; GLUCOCORTICOID;

ADULT; AGE; ARTICLE; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; CRITERION RELATED VALIDITY; CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DIARRHEA; DISEASE ACTIVITY; DISEASE DURATION; DRUG DOSE REDUCTION; ESOPHAGUS STRICTURE; FEMALE; GASTROINTESTINAL SURGERY; GENDER; HUMAN; MAJOR CLINICAL STUDY; MALE; PREDICTOR VARIABLE; PRIORITY JOURNAL; THERAPY EFFECT; TIME; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HOSPITALIZATION; RANDOMIZED CONTROLLED TRIAL; REMISSION; TREATMENT OUTCOME;

BUDESONIDE; CROHN DISEASE; GLUCOCORTICOIDS; HUMANS; REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 58149396867     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1111/j.1572-0241.2008.02176.x     Document Type: Article

References (28)

1. Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976 70 : 439 44.
2. Best WR BJ, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology 1979 77 : 843 6.
3. Sandborn WJ, Feagan BG, Hanauer SB, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology 2002 122 : 512 30.
4. Su C, Lichtenstein GR, Krok K, et al. A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease. Gastroenterology 2004 126 : 1257 69.
5. Campieri M, Ferguson A, Doe W, et al. Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group. Gut 1997 41 : 209 14.
6. Greenberg GR, Feagan BF, Martin F, et al. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med 1994 331 : 836 41.
7. Rutgeerts P, Lofberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994 331 : 842 5.
8. Thomsen OO, Cortot A, Jewell D, et al. A comparison of budesonide and mesalamine for active Crohn's disease. International Budesonide-Mesalamine Study Group. N Engl J Med 1998 339 : 370 74.
9. Tremaine WJ, Hanauer SB, Katz S, et al. Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: A randomized placebo-controlled study in the United States. Am J Gastroenterol 2002 97 : 1748 4.
10. Summers RW, Switz DM, Sessions JT, Jr., et al. National Cooperative Crohn's Disease Study: Results of drug treatment. Gastroenterology 1979 77 : 847 69.
11. Ghosh S, Goldin E, Gordon FH, et al. Natalizumab for active Crohn's disease. N Engl J Med 2003 348 : 24 32.
12. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: The CLASSIC I trial. Gastroenterology 2006 130 : 323 33.
13. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial. Gastroenterology 2007 132 : 56 65.
14. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med 1997 337 : 1029 35.
15. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med 2005 353 : 1912 25.
16. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn's disease previously treated with infliximab: A randomized trial. Ann Intern Med 2007 146 : 829 38.
17. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: The ACCENT I randomised trial. Lancet 2002 359 : 1541 9.
18. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. New Engl J Med 2007 357 : 228 38.
19. Schreiber S, Khaliq-Kareemi M, Lawrance I, et al. Certolizumab pegol maintenance therapy for Crohn's disease. New Engl J Med 2007 357 : 239 250.
20. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005 129 : 807 18.
21. Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn's disease: Results of the ENCORE Trial. Gastroenterology 2007 132 : 1672 83.
22. Kane SV, Schoenfeld P, Sandborn WJ, et al. The effectiveness of budesonide therapy for Crohn's disease. Aliment Pharmacol Ther 2002 16 : 1509 17.
23. Sands BE, Ooi CJ. A survey of methodological variation in the Crohn's disease activity index. Inflamm Bowel Dis 2005 11 : 133 8.
24. Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980 1 : 514.
25. Best WR. Predicting the Crohn's disease activity index from the Harvey-Bradshaw Index. Inflamm Bowel Dis 12 : 304 10.
26. Fredd S. Standards for approval of new drugs for IBD. Inflamm Bowel Dis 2005 1 : 284 94.
27. European Medicines Agency Committee For Medicinal Products For Human Use. Guidelines on the development of new medicinal products for the treatment of Crohn's disease. Available at : http://www.emea.europa.eu/pdfs/human/ewp/228499. pdf. 2007. Accessed July 1, 2008.
28. Irvine EJ, Feagan B, Rochon J, et al. Quality of life: A valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology 1994 106 : 287 96.