Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065570
• Other study ID #: M14-115
• Secondary ID: 2013-001746-33
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2014
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.

• Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.

• Mucosal ulceration on endoscopy.

Exclusion Criteria:

• Subject with ulcerative colitis or indeterminate colitis.

• Subject who has had surgical bowel resections in the past 6 months or is planning resection.

• Subjects with an ostomy or ileoanal pouch.

• Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

• Subject who has short bowel syndrome.

• Chronic recurring infections or active Tuberculosis (TB).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab

• Placebo

Locations

Country	Name	City	State
Austria	Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249	Innsbruck
Austria	KH der Elisabethinen Linz GmbH /ID# 126280	Linz	Oberoesterreich
Austria	LKH Salzburg and Paracelsus /ID# 126248	Salzburg
Austria	Krankenhaus der Barmherzigen Bruder /ID# 126270	St Veit An Der Glan
Austria	Medizinische Universitat Wien /ID# 126279	Vienna	Wien
Belgium	AZ Maria Middelares /ID# 126194	Ghent
Belgium	AZ Sint-Lucas /ID# 126242	Ghent
Belgium	UZ Leuven /ID# 126240	Leuven
Belgium	CHU de Liege /ID# 126241	Liege
Belgium	AZ-Delta /ID# 126195	Roeselare
Canada	University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017	Calgary	Alberta
Canada	University of Alberta /ID# 119022	Edmonton	Alberta
Canada	Qe Ii Hsc /Id# 127115	Halifax	Nova Scotia
Canada	London Health Sciences Centre - University Hospital /ID# 119026	London	Ontario
Canada	Montreal General Hospital - McGill University Health Center /ID# 119025	Montreal	Quebec
Canada	Medicor Research Inc /ID# 119024	Sudbury	Ontario
Canada	Toronto Digestive Disease Asso /ID# 119019	Vaughan	Ontario
Canada	Winnipeg Regional Health Authority /ID# 119015	Winnipeg	Manitoba
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 126266	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK s.r.o. /ID# 126269	Hradec Kralove
Czechia	Fakultni Nemocnice Olomouc /ID# 126264	Olomouc	Olomoucky Kraj
Czechia	ISCARE a.s. /ID# 137977	Praha 9
Czechia	Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331	Usti Nad Labem
Denmark	Herlev Hospital /ID# 127741	Herlev	Hovedstaden
Denmark	Silkeborg Hospital /ID# 126251	Silkeborg
France	CHU Amiens-Picardie Site Sud /ID# 126237	Amiens CEDEX 1	Somme
France	Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200	Grenoble
France	CHRU Lille - Hopital Claude Huriez /ID# 127743	Lille CEDEX	Hauts-de-France
France	Hopital l'Archet 2 /ID# 126238	Nice
France	CHU de Saint-Etienne, Hopital Nord /ID# 134450	SAINT-ETIENNE Cedex 1
France	Hopital Rangueil /ID# 126239	Toulouse
France	CHU NANCY - Hopital Brabois Adultes /ID# 127742	Vandoeuvre les Nancy CEDEX	Meurthe-et-Moselle
Germany	Charite Universitaetsmedizin Berlin /ID# 126196	Berlin
Germany	Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257	Berlin
Germany	Asklepios Westklinikum Hamburg /ID# 126275	Hamburg
Germany	Israelitisches Krankenhaus Hamburg /ID# 136549	Hamburg
Germany	Universitaetsklinikum Jena /ID# 126261	Jena
Germany	Universitaetsklinikum Schleswig-Holstein /ID# 126260	Kiel	Schleswig-Holstein
Germany	EUGASTRO GmbH /ID# 126259	Leipzig
Germany	Universitatsklinikum Magdeburg /ID# 126256	Magdeburg
Germany	Gastro Campus Research GbR /ID# 126274	Munster
Hungary	Magyar Elhizastudomanyi KKft. /ID# 126276	Budapest
Hungary	Semmelweis Egyetem /ID# 137896	Budapest
Hungary	Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895	Pecs
Hungary	University of Szeged /ID# 126263	Szeged
Israel	Soroka University Medical Center /ID# 126243	Be'er Sheva
Israel	Gastroenterology Institute, Division of Medicine /ID# 126245	Jerusalem
Israel	Rabin Medical Center /ID# 126198	Petakh Tikva	Tel-Aviv
Israel	Kaplan Medical Center /ID# 126246	Rehovot
Italy	Azienda Ospedaliera Spedali Civili /ID# 127744	Brescia
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221	Milan	Lombardia
Italy	Azienda Ospedaliera di Padova /ID# 126267	Padua
Italy	Policlinico Agostino Gemelli /ID# 127746	Rome	Lazio
Italy	UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745	Rome	Lazio
Italy	IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226	Rozzano	Milano
Italy	Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856	San Giovanni Rotondo
Netherlands	Academisch Medical center Amsterdam /ID# 126227	Amsterdam	Noord-Holland
Netherlands	Erasmus Medisch Centrum /ID# 126228	Rotterdam
Netherlands	Sint Franciscus Gasthuis /ID# 127877	Rotterdam
Poland	Centrum Endoskopii Zabiegowej /ID# 126272	Bydgoszcz
Poland	Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271	Czestochowa
Poland	Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974	Lodz	Lodzkie
Poland	KO-Med Centra Kliniczne Pulawi /ID# 126278	Pulawy
Poland	NZOZ Vivamed /ID# 126255	Warsaw
Poland	Endoterapia PFG sp. z o.o. /ID# 126199	Warszawa	Mazowieckie
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735	San Juan
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277	Brasov
Romania	Tvm Med Serv Srl /Id# 126268	Cluj
Romania	Cabinet Medical Dr. Fratila SRL /ID# 126247	Oradea
Romania	Institutul Clinic Fundeni /ID# 127747	Sector 2	Bucuresti
Romania	Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224	Zalau
Slovakia	Gastroenterologicka ambulancia /ID# 137964	Bratislava
Slovakia	Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262	Bratislava
Slovakia	Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748	Lucenec
Slovakia	Poliklinika Libris /ID# 126222	Nove Mesto Nad Vahom
Spain	Hospital Clinic /ID# 127749	Barcelona
Spain	Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976	Girona
Spain	Hospital de Leon /ID# 141675	Leon
Spain	Hospital Clinico Universitario San Carlos /ID# 126253	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425	Majadahonda	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 138126	Pontevedra
Spain	Hospital Parc Tauli de Sabadell /ID# 138124	Sabadell	Barcelona
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 126252	Zaragoza
Switzerland	Kantonsspital St. Gallen /ID# 127750	St. Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich /ID# 127751	Zurich	Zuerich
Ukraine	State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753	Kharkiv	Kharkivska Oblast
Ukraine	Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754	Kherson
Ukraine	Kyiv City Clinical Hospital No.8 /ID# 126232	Kiev
Ukraine	Lviv Regional Clinical Hospital /ID# 126234	Lviv
Ukraine	Public Institution 6th City Clinical Hospital /ID# 126236	Zaporizhzhia
United Kingdom	Hull University Teaching Hospitals NHS Trustust /ID# 126265	Hull
United Kingdom	Guy's and St Thomas' NHS Found /ID# 144366	London	London, City Of
United Kingdom	Norfolk and Norwich Univ Hosp /ID# 126197	Norwich	Norfolk
United Kingdom	University Hospital Southampton NHS Fundation Trust /ID# 126225	Southampton
United Kingdom	The Royal Wolverhampton NHS Tr /ID# 126201	Wolverhampton
United States	Albany Medical College /ID# 140200	Albany	New York
United States	University of Michigan Health Systems /ID# 119076	Ann Arbor	Michigan
United States	Investigative Clinical Research /ID# 119033	Annapolis	Maryland
United States	Atlanta Gastro Assoc /ID# 119065	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University /ID# 136851	Atlanta	Georgia
United States	Birmingham Gastroenterology Associates O.C /ID# 137282	Birmingham	Alabama
United States	Commonwealth Clinical Studies /ID# 136850	Brockton	Massachusetts
United States	Medical University of South Carolina /ID# 138122	Charleston	South Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041	Charlotte	North Carolina
United States	Erlanger Institute for Clinical Research /ID# 129008	Chattanooga	Tennessee
United States	Gastro Assoc of Tidewater /ID# 135897	Chesapeake	Virginia
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine /ID# 119043	Chicago	Illinois
United States	University of Chicago DCAM /ID# 119077	Chicago	Illinois
United States	New River Valley Research Inst /ID# 127807	Christiansburg	Virginia
United States	Consultants for Clinical Res /ID# 119052	Cincinnati	Ohio
United States	Texas Digestive Disease Consultants - Dallas /ID# 138121	Dallas	Texas
United States	Digestive Health Specialists of the Southeast /ID# 122483	Dothan	Alabama
United States	Gastro One /ID# 119068	Germantown	Tennessee
United States	NYU Langone Long Island Clinical Research Associates /ID# 119035	Great Neck	New York
United States	Medical Research Ctr CT /ID# 119037	Hamden	Connecticut
United States	Baylor College of Medicine /ID# 137277	Houston	Texas
United States	Kansas City Research Institute /ID# 119034	Kansas City	Missouri
United States	Moore UC San Diego Cancer Center /ID# 119053	La Jolla	California
United States	Axis Clinical Trials /ID# 130390	Los Angeles	California
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 119056	Macon	Georgia
United States	Ctr for Digest and Liver Dis /ID# 119040	Mexico	Missouri
United States	Froedtert Memorial Lutheran Hospital /ID# 119081	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036	Milwaukee	Wisconsin
United States	Gastroenterology Group Naples /ID# 122493	Naples	Florida
United States	Nashville Med Res Inst /ID# 119050	Nashville	Tennessee
United States	Vanderbilt Univ Med Ctr /ID# 125501	Nashville	Tennessee
United States	The Mount Sinai Hospital /ID# 127116	New York	New York
United States	Advanced Research Institute /ID# 119048	Ogden	Utah
United States	Internal Med Specialists /ID# 137737	Orlando	Florida
United States	Austin Institute for Clinical Research /ID# 125500	Pflugerville	Texas
United States	Minnesota Gastroenterology, P. A. /ID# 137280	Plymouth	Minnesota
United States	The Oregon Clinic, Gastroenterology - West /ID# 135272	Portland	Oregon
United States	Wake Research Associates, LLC /ID# 119029	Raleigh	North Carolina
United States	Mayo Clinic /ID# 122489	Rochester	Minnesota
United States	University of Utah /ID# 119062	Salt Lake City	Utah
United States	Louisana Research Center, LLC /ID# 136749	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants - Southlake /ID# 137283	Southlake	Texas
United States	Gastro United of Tulsa /ID# 122485	Tulsa	Oklahoma
United States	Carle Foundation Hospital Digestive Health Research Center /ID# 136008	Urbana	Illinois
United States	West Bay Clinical Research /ID# 138330	Warwick	Rhode Island
United States	Rocky Mountain Gastroenterology /ID# 119038	Wheat Ridge	Colorado
United States	Shafran Gastroenterology Ctr /ID# 119057	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Puerto Rico,  Romania,  Slovakia,  Spain,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Clinical Remission at Week 4	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.	Week 4
Primary	Percentage of Participants With Endoscopic Response at Week 12	Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.	Week 12
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.	From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Secondary	Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12	CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.	Week 4 and Week 12
Secondary	Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12	Clinical response was scored using CDAI, which assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI = 70 points from Baseline.; Endoscopic response was scored using the SES-CD, which evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score >50% from Baseline (or for Baseline SES-CD of 4, at least a 2-point reduction from Baseline) at Week 12.	Week 12
Secondary	Percentage of Participants With Clinical Remission at Week 12	Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.	Week 12
Secondary	Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline	Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.	Week 12
Secondary	Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD = 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.	Week 12
Secondary	Change From Baseline in Fecal Calprotectin Level at Week 4		Baseline, Week 4
Secondary	Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4		Week 4
Secondary	Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4	Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.	Week 4
Secondary	Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12	Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.; Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD = 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.	Week 12
Secondary	Percentage of Participants Who Achieved an SES-CD = 2 at Week 12	The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease.	Week 12
Secondary	Percentage of Participants With Clinical Response at Week 4	Clinical response was scored using CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI = 70 points from baseline.	Week 4
Secondary	Percentage of Participants With Clinical Response at Week 12	Clinical response was scored using CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI = 70 points from Baseline.	Week 12
Secondary	Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score = 8.	Week 4
Secondary	Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score = 8.	Week 12
Secondary	Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score = 1.	Week 12

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