Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
NCT ID: NCT00321412
Last Updated: 2014-05-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
191 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-03-31
Study Completion Date
2008-09-30
Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).
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Detailed Description
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The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth)preparations. Both are tasteless. To take the product, patients will tear open the sachets, drop the contents directly on their tongue and wash it down with 8 ounces of water.
Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a 'blinded' treatment, which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo.
If, at the end of the first full course of randomized treatment, (8 weeks), patients are not showing an improvement in their condition, they may have the option to receive the alternate blinded treatment for one treatment course (8 weeks). The study doctor will discuss this option with each patient individually. During this second course of treatment, patients will be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be removed from the study at the discretion of the investigator.
If patients respond to either the initial treatment or the alternate blinded treatment, they will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition worsens or they relapse. Patients will not receive any study drug during this follow-up period.
Relapse is defined for this study as:
* an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response (response is defined as at least a 50% reduction in the number of draining fistulas at either Week 8, or for those patients receiving alternate blinded treatment, Week 16).
There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a review of concomitant medications, medical history/adverse events, physical exam, fistula exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body weight. Patients will also be asked to keep a daily diary to record frequency of bowel movements, general well-being, and use of antidiarrheal medication.
Treatment failure in this study is defined by one or more of the following occurring prior to Week 8:
* The need for additional therapies or dose increase for treatment of Crohn's disease, including an increase of corticosteroid dose to higher than baseline
* Clinical/symptomatic development of an abscess
* Clinical/symptomatic evidence of stricture
* The need for surgical intervention for Crohn's disease
* The patient withdraws from the study
Patients will be discontinued from the study at any time if one or more of the following complications occur:
* Development of an abscess or symptomatic stricture
* The need for surgical intervention for Crohn's disease
* Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study
In addition, patients whose CDAI score has risen by \> or = 70 points above baseline or risen above 400 will be discontinued from the study.
Administration of any additional therapies or dose increases of concomitant medications (including corticosteroids) to control Crohn's disease to higher than baseline while receiving study drug (initial randomized treatment or alternate blinded treatment) will require discontinuation of the patient from the study.
Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given.
Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a 'blinded' treatment, which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo.
If, at the end of the first full course of randomized treatment, (8 weeks), patients are not showing an improvement in their condition, they may have the option to receive the alternate blinded treatment for one treatment course (8 weeks). The study doctor will discuss this option with each patient individually. During this second course of treatment, patients will be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be removed from the study at the discretion of the investigator.
If patients respond to either the initial treatment or the alternate blinded treatment, they will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition worsens or they relapse. Patients will not receive any study drug during this follow-up period.
Relapse is defined for this study as:
* an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response (response is defined as at least a 50% reduction in the number of draining fistulas at either Week 8, or for those patients receiving alternate blinded treatment, Week 16).
There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a review of concomitant medications, medical history/adverse events, physical exam, fistula exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body weight. Patients will also be asked to keep a daily diary to record frequency of bowel movements, general well-being, and use of antidiarrheal medication.
Treatment failure in this study is defined by one or more of the following occurring prior to Week 8:
* The need for additional therapies or dose increase for treatment of Crohn's disease, including an increase of corticosteroid dose to higher than baseline
* Clinical/symptomatic development of an abscess
* Clinical/symptomatic evidence of stricture
* The need for surgical intervention for Crohn's disease
* The patient withdraws from the study
Patients will be discontinued from the study at any time if one or more of the following complications occur:
* Development of an abscess or symptomatic stricture
* The need for surgical intervention for Crohn's disease
* Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study
In addition, patients whose CDAI score has risen by \> or = 70 points above baseline or risen above 400 will be discontinued from the study.
Administration of any additional therapies or dose increases of concomitant medications (including corticosteroids) to control Crohn's disease to higher than baseline while receiving study drug (initial randomized treatment or alternate blinded treatment) will require discontinuation of the patient from the study.
Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given.
Conditions
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Inflammatory Bowel Disease
Intestinal Fistula
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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2
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
Group Type
PLACEBO_COMPARATOR
AST-120
Intervention Type
DRUG
oral, sachet, 2 grams three times daily for 8 weeks
1
AST-120, 2 gram sachets
Group Type
EXPERIMENTAL
AST-120
Intervention Type
DRUG
oral, sachet, 2 grams three times daily for 8 weeks
Interventions
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AST-120
oral, sachet, 2 grams three times daily for 8 weeks
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Body Weight \> or = 40kg
* Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
* Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have \> or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have \> or = 1 draining perianal fistula.
* Crohn's Disease Activity Index (CDAI) score \< 400
* Platelet count (thrombocytes) \> or = 100,000/uL
* Able and willing to comply with all protocol procedures for the duration of the study
* Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
* Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
* Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
* Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have \> or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have \> or = 1 draining perianal fistula.
* Crohn's Disease Activity Index (CDAI) score \< 400
* Platelet count (thrombocytes) \> or = 100,000/uL
* Able and willing to comply with all protocol procedures for the duration of the study
* Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
* Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
Exclusion Criteria
* Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a \> or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included
* Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
* Presence of symptomatic strictures or suggestion of significant clinical obstruction
* Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
* Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
* Platelet count (thrombocytes) \< 100,000/uL
* CDAI score of \> or = 400
* Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
* Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
* Severe diarrhea defined by \> 10 liquid bowel movements per day
* Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
* Presence of an ileostomy
* Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
* Hemoglobin \< 8.5 g/dL (females) or hemoglobin \< 10 g/dL (males) at Screen
* Women who are pregnant, breast feeding, or planning to become pregnant during the study
* Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
* Uncontrolled systemic disease
* Patients undergoing chemotherapy for the treatment of cancer
* Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used
* Participation in another study within eight (8) weeks prior to the study
* Unable to attend all visits required by the protocol
* Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
* Presence of symptomatic strictures or suggestion of significant clinical obstruction
* Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
* Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
* Platelet count (thrombocytes) \< 100,000/uL
* CDAI score of \> or = 400
* Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
* Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
* Severe diarrhea defined by \> 10 liquid bowel movements per day
* Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
* Presence of an ileostomy
* Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
* Hemoglobin \< 8.5 g/dL (females) or hemoglobin \< 10 g/dL (males) at Screen
* Women who are pregnant, breast feeding, or planning to become pregnant during the study
* Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
* Uncontrolled systemic disease
* Patients undergoing chemotherapy for the treatment of cancer
* Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used
* Participation in another study within eight (8) weeks prior to the study
* Unable to attend all visits required by the protocol
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ocera Therapeutics
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Laurent Fischer, MD
Role: STUDY_DIRECTOR
Ocera Therapeutics
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Site Status
Digestive Care Medical Center
San Carlos, California, United States
Site Status
Shafran Gasteroenterology Center
Winter Park, Florida, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
University of Chicago Medical Center
Chicago, Illinois, United States
Site Status
Indiana University, Outpatient Clinical Research Facility
Indianapolis, Indiana, United States
Site Status
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Site Status
University of Louisville, Department of Surgery
Louisville, Kentucky, United States
Site Status
Metropolitan Gastroenterology Group/Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Site Status
Brigham & Women's Hospital
Boston, Massachusetts, United States
Site Status
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Site Status
Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA
Fort Lee, New Jersey, United States
Site Status
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Site Status
Mount Sinai School of Medicine, IBD Research Center
New York, New York, United States
Site Status
University of Rochester Medical Center
Rochester, New York, United States
Site Status
University of North Carolina
Chapel Hill, North Carolina, United States
Site Status
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Site Status
University Hospitals of Cleveland
Cleveland, Ohio, United States
Site Status
Cleveland Clinic - Department of Gastroenterology
Cleveland, Ohio, United States
Site Status
The Penn State University, Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Site Status
Digestive Disease Center/MUSC
Charleston, South Carolina, United States
Site Status
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States
Site Status
University of Washington
Seattle, Washington, United States
Site Status
Dean Foundation Research Center
Madison, Wisconsin, United States
Site Status
Univ Klinik fur Innere Medizin Innsbruck
Innsbruck, , Austria
Site Status
Universitatsklinik fur Innere Medizin I der PMU
Salzburg, , Austria
Site Status
AKH Wien - Univ Klinik Innere Med IV
Vienna, , Austria
Site Status
Imelda General Hospital
Bonheiden, , Belgium
Site Status
St. Jansziekenhuis/Ziekenhuis Oost-Limburg
Genk, , Belgium
Site Status
University Hospital Gasthuisberg, University of Leuven
Leuven, , Belgium
Site Status
H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, , Belgium
Site Status
GILDR Group, University of Edmonton
Edmonton, Alberta, Canada
Site Status
Liver & Intestinal Research Centre
Vancouver, British Columbia, Canada
Site Status
McMaster University Medical Centre
Hamilton, Ontario, Canada
Site Status
London Health Sciences Center
London, Ontario, Canada
Site Status
Jewish General Hospital
Montreal, Quebec, Canada
Site Status
University Hospital Brno, Internal and Gastroenterology Department
Brno, , Czechia
Site Status
Regional Hospital Liberec, Department of Gastroenterology
Liberec, , Czechia
Site Status
University Hospital Prague 2, 4th Department of Internal Medicine
Prague, , Czechia
Site Status
Thomayer's University Hospital Prague, 2nd Internal Department
Prague, , Czechia
Site Status
Institute for Clinical and Experimental Medicine
Prague, , Czechia
Site Status
CHU Hopital Nord, Service de Gastro-enterologie et nutrition
Amiens, , France
Site Status
Hopital de la Cote de Nacre - CHU
Caen, , France
Site Status
CHU de Grenoble - Hopital Nord
Grenoble, , France
Site Status
Hopital Claude Huriez, Service des maladies de l'appareil disgestif
Lille, , France
Site Status
Hopital Nord, Service de Gastro-Enterologie
Marseille, , France
Site Status
Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation
Montpelier, , France
Site Status
CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif
Nantes, , France
Site Status
CHU de Nice - Hopital de l'Archet 2
Nice, , France
Site Status
Hopital Leopold Bellan
Paris, , France
Site Status
Universitatsklinikum Aachen
Aachen, , Germany
Site Status
Charite-Campus Virchow-Klinikum
Berlin, , Germany
Site Status
Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main
Frankfurt, , Germany
Site Status
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie
Heidelberg, , Germany
Site Status
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Site Status
Klinikum rechts der Isar der TUM II
München, , Germany
Site Status
Universitatsklinikum Regensburg
Regensburg, , Germany
Site Status
Universitat Rostock - Midizinische Fakultat
Rostock, , Germany
Site Status
Medizinische Universitatsklinik Tubingen
Tübingen, , Germany
Site Status
Universitatsklinikum Ulm
Ulm, , Germany
Site Status
Peterfy Sandor utcai Korhaz-Rendelointezet
Budapest, , Hungary
Site Status
Semmelweis Egyetem
Budapest, , Hungary
Site Status
Semmelweis Egyetem
Budapest, , Hungary
Site Status
Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet
Miskolc, , Hungary
Site Status
Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika
Szeged, , Hungary
Site Status
Bnai Zion Medical Center
Haifa, , Israel
Site Status
Rambam Medical Center
Haifa, , Israel
Site Status
Strauss Medical Center
Jerusalem, , Israel
Site Status
Meir Hospital
Kfar Saba, , Israel
Site Status
Rabin Medical Center, Bellinson Hospital
Petah Tikva, , Israel
Site Status
Sheba Medical Center
Ramat Gan, , Israel
Site Status
Kaplan Medical Center
Rehovot, , Israel
Site Status
Erasmus MC, Department of Gastroenterology and Hepatology
Rotterdam, , Netherlands
Site Status
Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM
Katowice, , Poland
Site Status
Zakaznych Szpitala Uniwersyteckiego w Krakowie
Krakow, , Poland
Site Status
Korektalnej Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Site Status
University Hospital Olomouc, 2nd Internal Department
Olomouc, , Poland
Site Status
Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora
Poznan, , Poland
Site Status
Samodzielny Publiczny Centralny Szpital
Warsaw, , Poland
Site Status
Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu
Wroclaw, , Poland
Site Status
Bristol Royal Infirmary, Dept. of Gastroenterology
Bristol, , United Kingdom
Site Status
Countess of Chester Hospital
Chester, , United Kingdom
Site Status
Crosshouse Hospital
Kilmarnock, , United Kingdom
Site Status
Leicester General Hospital - GI Research Unit
Leicester, , United Kingdom
Site Status
University College London Hospital, Dept. of Gastroenterology
London, , United Kingdom
Site Status
John Radcliffe Hospital, Dept. of Gastroenterology
Oxford, , United Kingdom
Site Status
Countries
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United States
Austria
Belgium
Canada
Czechia
France
Germany
Hungary
Israel
Netherlands
Poland
United Kingdom
References
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Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17. doi: 10.1097/00004836-199206000-00009.
Reference Type
BACKGROUND
Hugot JP, Chamaillard M, Zouali H, Lesage S, Cezard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603. doi: 10.1038/35079107.
Reference Type
BACKGROUND
Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nunez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6. doi: 10.1038/35079114.
Reference Type
BACKGROUND
Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.
Reference Type
BACKGROUND
Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. doi: 10.1053/gast.2002.32362.
Reference Type
BACKGROUND
Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
Reference Type
BACKGROUND
Farmer RG, Hawk WA, Turnbull RB Jr. Clinical patterns in Crohn's disease: a statistical study of 615 cases. Gastroenterology. 1975 Apr;68(4 Pt 1):627-35. No abstract available.
Reference Type
BACKGROUND
Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24. doi: 10.1136/gut.6.6.515. No abstract available.
Reference Type
BACKGROUND
Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. doi: 10.7326/0003-4819-135-10-200111200-00011.
Reference Type
BACKGROUND
Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. doi: 10.1111/j.1365-2036.2004.01917.x.
Reference Type
BACKGROUND
Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.
Reference Type
BACKGROUND
Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. doi: 10.1056/NEJM198005013021801.
Reference Type
BACKGROUND
Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.
Reference Type
BACKGROUND
Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.
Reference Type
BACKGROUND
Other Identifiers
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AST001
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE2
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
NCT06681324
RECRUITING
PHASE2
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
NCT05470985
TERMINATED
PHASE2/PHASE3
Study to Look at Benefit of Surgical Drainage Before Beginning Medical Therapy for Crohns Perianal Fistulas
NCT01145365
COMPLETED
NA
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
NCT00999115
COMPLETED
PHASE1/PHASE2
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT04673357
COMPLETED
PHASE3
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease
NCT06514092
RECRUITING
Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients
NCT02129439
COMPLETED
PHASE1/PHASE2
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
NCT01624376
COMPLETED
PHASE2
Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
NCT01375179
TERMINATED
PHASE2
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
NCT01369342
COMPLETED
PHASE3
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
NCT01258205
COMPLETED
PHASE1
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
NCT03440385
COMPLETED
PHASE3
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
NCT03996369
COMPLETED
PHASE3
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
NCT01369329
COMPLETED
PHASE3
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease
NCT01635621
WITHDRAWN
PHASE2
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
NCT01612039
COMPLETED
PHASE2
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
NCT03358706
TERMINATED
PHASE1
Study for the Treatment of Crohn's Disease With Adacolumn
NCT00162942
COMPLETED
PHASE3
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease
NCT04151225
WITHDRAWN
PHASE2
Study of the 12-month Efficacy of Stem Cell Injection in Crohn's Disease With Complex Ano-perineal Fistula
NCT05177003
UNKNOWN
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
NCT04877990
COMPLETED
PHASE2
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
NCT01559142
UNKNOWN
PHASE3