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Inflammatory Bowel Disease (IBD)

Level: Clinical Trials: 33 Abstracts

Legend: : Key Development,  : Very Important,  : Important, [no star]: Special Mention

   

Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease: A Randomized Clinical Trial.
Hawkey CJ, Allez M, Clark MM, Labopin M, Lindsay JO, Ricart E, Rogler G, Rovira M, Satsangi J, Danese S, Russell N, Gribben J, Johnson P, Larghero J, Thieblemont C, Ardizzone S, Dierickx D, Ibatici A, Littlewood T, Onida F, Schanz U, Vermeire S, et al., JAMA. 2015 Dec 15;314(23):2524-34. doi: 10.1001/jama.2015.16700.

Comments: End of a myth

   

Loss of Infliximab Into Feces Is Associated With Lack of Response to Therapy in Patients With Severe Ulcerative Colitis.
Brandse JF, van den Brink GR, Wildenberg ME, van der Kleij D, Rispens T, Jansen JM, Mahôt RA, Ponsioen CY, Löwenberg M, D'Haens GR., Gastroenterology. 2015 Aug;149(2):350-5.e2. doi: 10.1053/j.gastro.2015.04.016. Epub 2015 Apr 25.

   

The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn's disease.
Vande Casteele N, Khanna R, Levesque BG, Stitt L, Zou GY, Singh S, Lockton S, Hauenstein S, Ohrmund L, Greenberg GR, Rutgeerts PJ, Gils A, Sandborn WJ, Vermeire S, Feagan BG., Gut. 2015 Oct;64(10):1539-45. doi: 10.1136/gutjnl-2014-307883. Epub 2014 Oct 21.

   

Inherited determinants of Crohn's disease and ulcerative colitis phenotypes: a genetic association study.
Cleynen I, Boucher G, Jostins L, Schumm LP, Zeissig S, Ahmad T, Andersen V, Andrews JM, Annese V, Brand S, Brant SR, Cho JH, Daly MJ, Dubinsky M, Duerr RH, Ferguson LR, Franke A, Gearry RB, Goyette P, Hakonarson H, Halfvarson J, Hov JR, et al., Lancet. 2016 Jan 9;387(10014):156-67. doi: 10.1016/S0140-6736(15)00465-1. Epub 2015 Oct 18.

   

Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial.
Cornillie F, Hanauer SB, Diamond RH, Wang J, Tang KL, Xu Z, Rutgeerts P, Vermeire S., Gut. 2014 Nov;63(11):1721-7. doi: 10.1136/gutjnl-2012-304094. Epub 2014 Jan 28.
Comments: Serum infliximab trough levels are important!

   

Identification of inflammatory mediators in patients with Crohn's disease unresponsive to anti-TNFa therapy.
Leal RF, Planell N, Kajekar R, Lozano JJ, Ordás I, Dotti I, Esteller M, Masamunt MC, Parmar H, Ricart E, Panés J, Salas A., Gut. 2015 Feb;64(2):233-42. doi: 10.1136/gutjnl-2013-306518. Epub 2014 Apr 3.
Comments: Looking after transcriptional signature of anti-TNF treatment…

   

Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis.
Adedokun OJ, Sandborn WJ, Feagan BG, Rutgeerts P, Xu Z, Marano CW, Johanns J, Zhou H, Davis HM, Cornillie F, Reinisch W., Gastroenterology. 2014 Dec;147(6):1296-1307.e5. doi: 10.1053/j.gastro.2014.08.035. Epub 2014 Aug 28.
Comments: Serum concentrations of infliximab and its effect in UC

 

Infliximab, azathioprine, or combination therapy for Crohn's disease.
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group., N Engl J Med. 2010 Apr 15;362(15):1383-95.

  

Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis.
Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group., N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.

  

Inherited determinants of Crohn's disease and ulcerative colitis phenotypes: a genetic association study.
Cleynen I, Boucher G, Jostins L, Schumm LP, Zeissig S, Ahmad T, Andersen V, Andrews JM, Annese V, Brand S, Brant SR, Cho JH, Daly MJ, Dubinsky M, Duerr RH, Ferguson LR, Franke A, Gearry RB, Goyette P, Hakonarson H, Halfvarson J, Hov JR, et al., Lancet. 2016 Jan 9;387(10014):156-67. doi: 10.1016/S0140-6736(15)00465-1. Epub 2015 Oct 18.

  

Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells Promote Healing of Refractory Perianal Fistulas in Patients With Crohn's Disease.
Molendijk I, Bonsing BA, Roelofs H, Peeters KC, Wasser MN, Dijkstra G, van der Woude CJ, Duijvestein M, Veenendaal RA, Zwaginga JJ, Verspaget HW, Fibbe WE, van der Meulen-de Jong AE, Hommes DW., Gastroenterology. 2015 Oct;149(4):918-27.e6. doi: 10.1053/j.gastro.2015.06.014. Epub 2015 Jun 25.

  

Identification of Patients With Variants in TPMT and Dose Reduction Reduces Hematologic Events During Thiopurine Treatment of Inflammatory Bowel Disease.
Coenen MJ, de Jong DJ, van Marrewijk CJ, Derijks LJ, Vermeulen SH, Wong DR, Klungel OH, Verbeek AL, Hooymans PM, Peters WH, te Morsche RH, Newman WG, Scheffer H, Guchelaar HJ, Franke B; TOPIC Recruitment Team., Gastroenterology. 2015 Oct;149(4):907-17.e7. doi: 10.1053/j.gastro.2015.06.002. Epub 2015 Jun 11.

  

Efficacy of oral methotrexate in paediatric Crohn's disease: a multicentre propensity score study.
Turner D, Doveh E, Cohen A, Wilson ML, Grossman AB, Rosh JR, Lu Y, Bousvaros A, Deslandres C, Noble A, Baldassano RN, Levine A, Lerner A, Wilson DC, Griffiths AM., Gut. 2015 Dec;64(12):1898-904. doi: 10.1136/gutjnl-2014-307964. Epub 2014 Nov 21.

  

A phase II study of laquinimod in Crohn's disease.
D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators., Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.

  

Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study.
Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S., Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.
Comments: An IL-13 neutralizing antibody in UC: no spectacular effects...

  

Measurement of fecal calprotectin improves monitoring and detection of recurrence of Crohn's disease after surgery.
Wright EK, Kamm MA, De Cruz P, Hamilton AL, Ritchie KJ, Krejany EO, Leach S, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Jakobovits SL, Florin TH, Gibson PR, Debinski H, Macrae FA, Samuel D, Kronborg I, Radford-Smith G, Selby W, et al., Gastroenterology. 2015 May;148(5):938-947.e1. doi: 10.1053/j.gastro.2015.01.026. Epub 2015 Jan 22.
 

  

Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study.
Reinisch W, Panés J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F., Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.
 

  

Crohn's disease management after intestinal resection: a randomised trial.
De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Gibson PR, Sparrow M, Leong RW, Florin TH, Gearry RB, Radford-Smith G, Macrae FA, Debinski H, Selby W, Kronborg I, Johnston MJ, et al., Lancet. 2015 Apr 11;385(9976):1406-17. doi: 10.1016/S0140-6736(14)61908-5. Epub 2014 Dec 24.
 

  

Abnormal fibre usage in UC in remission.
James SL, Christophersen CT, Bird AR, Conlon MA, Rosella O, Gibson PR, Muir JG., Gut. 2015 Apr;64(4):562-70. doi: 10.1136/gutjnl-2014-307198. Epub 2014 Jul 18.
 

  

Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3.
Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB., Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.
Comments: Adalimumab in maintenance treatment of UC

 

Narrow-band imaging versus high-definition endoscopy for the diagnosis of neoplasia in ulcerative colitis.
van den Broek FJ, Fockens P, van Eeden S, Stokkers PC, Ponsioen CY, Reitsma JB, Dekker E., Endoscopy. 2011 Feb;43(2):108-15. Epub 2010 Dec 16.

 

Randomised clinical trial: improvement in health outcomes with certolizumab pegolin patients with active Crohn's disease with prior loss of response toinfliximab.
Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ., Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi:10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.

 

Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerativecolitis.
Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S., Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. Epub 2010 Jan 11.

 

Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab.
Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF, Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520

 

Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease.
Marehbian J, Arrighi HM, Hass S, Tian H, Sandborn WJ, Am J Gastroenterol. 2009 Oct;104(10):2524-33

 

Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study.
Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ, Gut. 2009 Oct;58(10):1354-62

 

Oral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis: results from a double-blind, randomized, parallel group study.
Van Assche G, Manguso F, Zibellini M, Cabriada Nuño JL, Goldis A, Tkachenko E, Varoli G, Kleczkowski D, Annese V, D'Heygere F, Balzano A; BETA study participating centers., Am J Gastroenterol. 2015 May;110(5):708-15. doi: 10.1038/ajg.2015.114. Epub 2015 Apr 14.
 

 

Early endoscopic, laboratory and clinical predictors of poor disease course in paediatric ulcerative colitis.
Schechter A, Griffiths C, Gana JC, Shaoul R, Shamir R, Shteyer E, Bdolah-Abram T, Ledder O, Turner D., Gut. 2015 Apr;64(4):580-8. doi: 10.1136/gutjnl-2014-306999. Epub 2014 May 21.
 

 

Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis.
Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Bátovský M, Lozynsky YS, Zakharash Y, Rácz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group., Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi:10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8.

 

Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4g/day in endoscopic mucosal healing--ASCEND I and II combined analysis.
Lichtenstein GR, Ramsey D, Rubin DT., Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi:10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.

 

Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis.
Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR., Gut. 2010 Nov;59(11):1485-92.

 

Direct comparison of two different mesalamine formulations for the maintenance of remission in patients with ulcerative colitis: a double-blind, randomized study.
Ito H, Iida M, Matsumoto T, Suzuki Y, Aida Y, Yoshida T, Takano Y, Hibi T., Inflamm Bowel Dis. 2010 Sep;16(9):1575-82.

 

Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study.
Ito H, Iida M, Matsumoto T, Suzuki Y, Sasaki H, Yoshida T, Takano Y, Hibi T., Inflamm Bowel Dis. 2010 Sep;16(9):1567-74.

 

Newly developed antibiotic combination therapy for ulcerative colitis: a double-blind placebo-controlled multicenter trial.
Ohkusa T, Kato K, Terao S, Chiba T, Mabe K, Murakami K, Mizokami Y, Sugiyama T,Yanaka A, Takeuchi Y, Yamato S, Yokoyama T, Okayasu I, Watanabe S, Tajiri H, Sato N; Japan UC Antibiotic Therapy Study Group., Am J Gastroenterol. 2010 Aug;105(8):1820-9. Epub 2010 Mar 9.

 

Clinical trial: controlled, open, randomized multicentre study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left-sided ulcerative colitis.
Hartmann F, Stein J; BudMesa-Study Group., Aliment Pharmacol Ther. 2010 Aug;32(3):368-76. Epub 2010 May 11.

 

Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort.
Gies N, Kroeker KI, Wong K, Fedorak RN., Aliment Pharmacol Ther. 2010 Aug;32(4):522-8. Epub 2010 May 25.

 

Surveillance programmes for neoplasia in colitis.
Rutter MD., J Gastroenterol. 2011 Jan;46 Suppl 1:1-5. Epub 2010 Aug 27.

 

Histomorphometric analysis reveals reduced bone mass and bone formation inpatients with quiescent Crohn's disease.
Oostlander AE, Bravenboer N, Sohl E, Holzmann PJ, van der Woude CJ, Dijkstra G, Stokkers PC, Oldenburg B, Netelenbos JC, Hommes DW, van Bodegraven AA, Lips P;Dutch Initiative on Crohn and Colitis (ICC)., Gastroenterology. 2011 Jan;140(1):116-23. Epub 2010 Sep 18.

 

Clinical trial: effects of an oral preparation of mesalazine at 4 g/day on moderately active ulcerative colitis. A phase III parallel-dosing study.
Hiwatashi N, Suzuki Y, Mitsuyama K, Munakata A, Hibi T., J Gastroenterol. 2011 Jan;46(1):46-56. Epub 2010 Sep 29.

 

Clinical trial: colectomy after rescue therapy in ulcerative colitis - 3-yearfollow-up of the Swedish-Danish controlled infliximab study.
Gustavsson A, Järnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlén P,Grännö C, Vilien M, Ström M, Verbaan H, Hellström PM, Magnuson A, Halfvarson J, Tysk C., Aliment Pharmacol Ther. 2010 Oct;32(8):984-9. doi:10.1111/j.1365-2036.2010.04435.x. Epub 2010 Aug 18.

 

Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis.
Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR., Gut. 2010 Nov;59(11):1485-92.

 

Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized,double-blind, placebo-controlled, multiple-dose study.
Reinisch W, de Villiers W, Bene L, Simon L, Rácz I, Katz S, Altorjay I, Feagan B, Riff D, Bernstein CN, Hommes D, Rutgeerts P, Cortot A, Gaspari M, Cheng M, Pearce T, Sands BE., Inflamm Bowel Dis. 2010 Feb;16(2):233-42.

 

Randomized, placebo-controlled, double-blind trial of Boswellia serrata in maintaining remission of Crohn's disease: good safety profile but lack of efficacy.
Holtmeier W, Zeuzem S, Preiss J, Kruis W, Böhm S, Maaser C, Raedler A, Schmidt C,Schnitker J, Schwarz J, Zeitz M, Caspary W., Inflamm Bowel Dis. 2011 Feb;17(2):573-82.

 

Anxiety and depression in patients with inflammatory bowel disease: comparisons with chronic liver disease patients and the general population.
Häuser W, Janke KH, Klump B, Hinz A., Inflamm Bowel Dis. 2011 Feb;17(2):621-32.

 

Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
Tromm A, Bunganic I, Tomsová E, Tulassay Z, Luká� M, Kykal J, Bátovský M, Fixa B,Gabalec L, Safadi R, Kramm HJ, Altorjay I, Löhr H, Koutroubakis I, Bar-Meir S,Stimac D, Schäffeler E, Glasmacher C, Dilger K, Mohrbacher R, Greinwald R;International Budenofalk Study Group., Gastroenterology. 2011 Feb;140(2):425-434.e1; quiz e13-4. Epub 2010 Nov 9.

 

E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach.
Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, Avnstrøm S, Langholz E, O'Morain C, Lynge E, Munkholm P., Gut. 2010 Dec;59(12):1652-61.

 

Efficacy of methotrexate in ulcerative colitis: failure or promise.
Herfarth HH, Osterman MT, Isaacs KL, Lewis JD, Sands BE., Inflamm Bowel Dis. 2010 Aug;16(8):1421-30.

 

A randomized controlled trial of growth hormone in active pediatric Crohn disease.
Denson LA, Kim MO, Bezold R, Carey R, Osuntokun B, Nylund C, Willson T, BonkowskiE, Li D, Ballard E, Collins M, Moyer MS, Klein DJ., J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):130-9.

 

Treatment of relapsing mild-to-moderate ulcerative colitis with the probioticVSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study.
Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, MoriniS, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, Gasbarrini A., Am J Gastroenterol. 2010 Oct;105(10):2218-27. Epub 2010 Jun 1.

 

Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis - a 6-month placebo-controlled trial.
Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Merchant K, Shaw A, Bortey E, Forbes WP., Aliment Pharmacol Ther. 2010 Oct;32(8):990-9. doi:10.1111/j.1365-2036.2010.04438.x. Epub 2010 Aug 18.

 

Evaluation of the intestinal colonization by microencapsulated probiotic bacteriain comparison with the same uncoated strains.
Del Piano M, Carmagnola S, Andorno S, Pagliarulo M, Tari R, Mogna L, Strozzi GP, Sforza F, Capurso L., J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S42-6.

 

Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study.
Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, Morini S, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, Gasbarrini A., Am J Gastroenterol. 2010 Oct;105(10):2218-27. Epub 2010 Jun 1.

 

The use of probiotics in healthy volunteers with evacuation disorders and hardstools: a double-blind, randomized, placebo-controlled study.
Del Piano M, Carmagnola S, Anderloni A, Andorno S, Ballarè M, Balzarini M,Montino F, Orsello M, Pagliarulo M, Sartori M, Tari R, Sforza F, Capurso L., J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S30-4.

 

Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX) foractive left-sided ulcerative colitis.
Celasco G, Papa A, Jones R, Moro L, Bozzella R, Surace MM, Naccari GC, Gasbarrini G., Aliment Pharmacol Ther. 2010 Feb 1;31(3):375-86. Epub 2009 Nov 5.