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

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Birmingham Gastroenterology Associates O.C /ID# 137282
Digestive Health Specialists of the Southeast /ID# 122483
Moore UC San Diego Cancer Center /ID# 119053
Axis Clinical Trials /ID# 130390
Rocky Mountain Gastroenterology /ID# 119038
Medical Research Ctr CT /ID# 119037
Gastroenterology Group Naples /ID# 122493
Internal Med Specialists /ID# 137737
Shafran Gastroenterology Ctr /ID# 119057
Winship Cancer Institute of Emory University /ID# 136851
Atlanta Gastro Assoc /ID# 119065
Gastroenterology Associates of Central Georgia, LLC /ID# 119056
Northwestern University Feinberg School of Medicine /ID# 119043
University of Chicago DCAM /ID# 119077
Carle Foundation Hospital Digestive Health Research Center /ID# 136008
Louisana Research Center, LLC /ID# 136749
Investigative Clinical Research /ID# 119033
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042
Commonwealth Clinical Studies /ID# 136850
University of Michigan Health Systems /ID# 119076
Minnesota Gastroenterology, P. A. /ID# 137280
Mayo Clinic /ID# 122489
Kansas City Research Institute /ID# 119034
Ctr for Digest and Liver Dis /ID# 119040
Albany Medical College /ID# 140200
NYU Langone Long Island Clinical Research Associates /ID# 119035
The Mount Sinai Hospital /ID# 127116
Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041
Wake Research Associates, LLC /ID# 119029
Consultants for Clinical Res /ID# 119052
Gastro United of Tulsa /ID# 122485
The Oregon Clinic, Gastroenterology - West /ID# 135272
West Bay Clinical Research /ID# 138330
Medical University of South Carolina /ID# 138122
Erlanger Institute for Clinical Research /ID# 129008
Gastro One /ID# 119068
Nashville Med Res Inst /ID# 119050
Vanderbilt Univ Med Ctr /ID# 125501
Texas Digestive Disease Consultants - Dallas /ID# 138121
Baylor College of Medicine /ID# 137277
Austin Institute for Clinical Research /ID# 125500
Texas Digestive Disease Consultants - Southlake /ID# 137283
Advanced Research Institute /ID# 119048
University of Utah /ID# 119062
Gastro Assoc of Tidewater /ID# 135897
New River Valley Research Inst /ID# 127807
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036
Froedtert Memorial Lutheran Hospital /ID# 119081
KH der Elisabethinen Linz GmbH /ID# 126280
Medizinische Universitat Wien /ID# 126279
Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249
LKH Salzburg and Paracelsus /ID# 126248
Krankenhaus der Barmherzigen Bruder /ID# 126270
AZ Maria Middelares /ID# 126194
AZ Sint-Lucas /ID# 126242
UZ Leuven /ID# 126240
CHU de Liege /ID# 126241
AZ-Delta /ID# 126195
University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017
University of Alberta /ID# 119022
Winnipeg Regional Health Authority /ID# 119015
Qe Ii Hsc /Id# 127115
London Health Sciences Centre - University Hospital /ID# 119026
Medicor Research Inc /ID# 119024
Toronto Digestive Disease Asso /ID# 119019
Montreal General Hospital - McGill University Health Center /ID# 119025
Fakultni Nemocnice Olomouc /ID# 126264
Nemocnice Ceske Budejovice a.s. /ID# 126266
Hepato-Gastroenterologie HK s.r.o. /ID# 126269
ISCARE a.s. /ID# 137977
Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331
Herlev Hospital /ID# 127741
Silkeborg Hospital /ID# 126251
CHRU Lille - Hopital Claude Huriez /ID# 127743
CHU NANCY - Hopital Brabois Adultes /ID# 127742
CHU Amiens-Picardie Site Sud /ID# 126237
Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200
Hopital l'Archet 2 /ID# 126238
CHU de Saint-Etienne, Hopital Nord /ID# 134450
Hopital Rangueil /ID# 126239
Universitaetsklinikum Schleswig-Holstein /ID# 126260
Charite Universitaetsmedizin Berlin /ID# 126196
Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257
Israelitisches Krankenhaus Hamburg /ID# 136549
Asklepios Westklinikum Hamburg /ID# 126275
Universitaetsklinikum Jena /ID# 126261
EUGASTRO GmbH /ID# 126259
Universitatsklinikum Magdeburg /ID# 126256
Gastro Campus Research GbR /ID# 126274
Semmelweis Egyetem /ID# 137896
Magyar Elhizastudomanyi KKft. /ID# 126276
Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895
University of Szeged /ID# 126263
Rabin Medical Center /ID# 126198
Soroka University Medical Center /ID# 126243
Gastroenterology Institute, Division of Medicine /ID# 126245
Kaplan Medical Center /ID# 126246
UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745
Policlinico Agostino Gemelli /ID# 127746
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226
Azienda Ospedaliera Spedali Civili /ID# 127744
Azienda Ospedaliera di Padova /ID# 126267
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856
Academisch Medical center Amsterdam /ID# 126227
Erasmus Medisch Centrum /ID# 126228
Sint Franciscus Gasthuis /ID# 127877
Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974
Endoterapia PFG sp. z o.o. /ID# 126199
Centrum Endoskopii Zabiegowej /ID# 126272
Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271
KO-Med Centra Kliniczne Pulawi /ID# 126278
NZOZ Vivamed /ID# 126255
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735
Institutul Clinic Fundeni /ID# 127747
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277
Tvm Med Serv Srl /Id# 126268
Cabinet Medical Dr. Fratila SRL /ID# 126247
Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262
Gastroenterologicka ambulancia /ID# 137964
Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748
Poliklinika Libris /ID# 126222
Hospital Parc Tauli de Sabadell /ID# 138124
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425
Hospital Clinic /ID# 127749
Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976
Hospital de Leon /ID# 141675
Hospital Clinico Universitario San Carlos /ID# 126253
Complejo Hospitalario Universitario de Pontevedra /ID# 138126
Hospital Clinico Universitario Lozano Blesa /ID# 126252
Kantonsspital St. Gallen /ID# 127750
Universitaetsspital Zuerich /ID# 127751
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754
Kyiv City Clinical Hospital No.8 /ID# 126232
Lviv Regional Clinical Hospital /ID# 126234
Public Institution 6th City Clinical Hospital /ID# 126236
Guy's and St Thomas' NHS Found /ID# 144366
Norfolk and Norwich Univ Hosp /ID# 126197
Hull University Teaching Hospitals NHS Trustust /ID# 126265
University Hospital Southampton NHS Fundation Trust /ID# 126225
The Royal Wolverhampton NHS Tr /ID# 126201

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Induction: Standard Induction Dose

Induction: Higher Induction Dose

Maintenance: Clinically Adjusted (CA) Regimen

Maintenance: Therapeutic Drug Monitoring (TDM) Regimen

Arm Description

Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.

Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.

Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.

At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM will be determined by protocol-established dose adjustment criteria. Doses will be determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 will receive 40 mg ew.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

Percentage of Participants With Clinical Remission at Week 12

Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline

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.

Change From Baseline in Fecal Calprotectin Level at Week 4

Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4

Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4

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.

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.

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.

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.

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.

Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12

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.

Full Information

NCT ID

NCT02065570

First Posted

February 17, 2014

Last Updated

February 11, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02065570

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2014 (Actual)

Primary Completion Date

January 30, 2020 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

514 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Induction: Standard Induction Dose

Arm Type

Experimental

Arm Description

Arm Title

Induction: Higher Induction Dose

Arm Type

Experimental

Arm Description

Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.

Arm Title

Maintenance: Clinically Adjusted (CA) Regimen

Arm Type

Experimental

Arm Description

Arm Title

Maintenance: Therapeutic Drug Monitoring (TDM) Regimen

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

Humira

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved Clinical Remission at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants With Endoscopic Response at Week 12

Description

Time Frame

Week 12

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

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 Outcome Measure Information:

Title

Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12

Description

Time Frame

Week 4 and Week 12

Title

Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With Clinical Remission at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline

Description

Time Frame

Week 12

Title

Percentage of Participants With Endoscopic Remission at Week 12

Description

Time Frame

Week 12

Title

Change From Baseline in Fecal Calprotectin Level at Week 4

Time Frame

Baseline, Week 4

Title

Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4

Time Frame

Week 4

Title

Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With Clinical Response at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants With Clinical Response at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4

Description

Time Frame

Week 4

Title

Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12

Description

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.

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Birmingham Gastroenterology Associates O.C /ID# 137282

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Digestive Health Specialists of the Southeast /ID# 122483

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Moore UC San Diego Cancer Center /ID# 119053

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Axis Clinical Trials /ID# 130390

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Rocky Mountain Gastroenterology /ID# 119038

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Medical Research Ctr CT /ID# 119037

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Gastroenterology Group Naples /ID# 122493

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Internal Med Specialists /ID# 137737

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Shafran Gastroenterology Ctr /ID# 119057

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Winship Cancer Institute of Emory University /ID# 136851

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Atlanta Gastro Assoc /ID# 119065

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Gastroenterology Associates of Central Georgia, LLC /ID# 119056

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine /ID# 119043

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-2927

Country

United States

Facility Name

University of Chicago DCAM /ID# 119077

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1443

Country

United States

Facility Name

Carle Foundation Hospital Digestive Health Research Center /ID# 136008

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

Louisana Research Center, LLC /ID# 136749

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105-6800

Country

United States

Facility Name

Investigative Clinical Research /ID# 119033

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

Facility Name

MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Commonwealth Clinical Studies /ID# 136850

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02302

Country

United States

Facility Name

University of Michigan Health Systems /ID# 119076

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Minnesota Gastroenterology, P. A. /ID# 137280

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55446

Country

United States

Facility Name

Mayo Clinic /ID# 122489

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905-0001

Country

United States

Facility Name

Kansas City Research Institute /ID# 119034

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64131

Country

United States

Facility Name

Ctr for Digest and Liver Dis /ID# 119040

City

Mexico

State/Province

Missouri

ZIP/Postal Code

65265

Country

United States

Facility Name

Albany Medical College /ID# 140200

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

NYU Langone Long Island Clinical Research Associates /ID# 119035

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

The Mount Sinai Hospital /ID# 127116

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Wake Research Associates, LLC /ID# 119029

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Consultants for Clinical Res /ID# 119052

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Gastro United of Tulsa /ID# 122485

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

The Oregon Clinic, Gastroenterology - West /ID# 135272

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

West Bay Clinical Research /ID# 138330

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Medical University of South Carolina /ID# 138122

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Erlanger Institute for Clinical Research /ID# 129008

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

Gastro One /ID# 119068

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Nashville Med Res Inst /ID# 119050

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Vanderbilt Univ Med Ctr /ID# 125501

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-0011

Country

United States

Facility Name

Texas Digestive Disease Consultants - Dallas /ID# 138121

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Baylor College of Medicine /ID# 137277

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-3411

Country

United States

Facility Name

Austin Institute for Clinical Research /ID# 125500

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Texas Digestive Disease Consultants - Southlake /ID# 137283

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

Advanced Research Institute /ID# 119048

City

Ogden

State/Province

Utah

ZIP/Postal Code

84403

Country

United States

Facility Name

University of Utah /ID# 119062

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112-5500

Country

United States

Facility Name

Gastro Assoc of Tidewater /ID# 135897

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

New River Valley Research Inst /ID# 127807

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Froedtert Memorial Lutheran Hospital /ID# 119081

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226-3522

Country

United States

Facility Name

KH der Elisabethinen Linz GmbH /ID# 126280

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

4010

Country

Austria

Facility Name

Medizinische Universitat Wien /ID# 126279

City

Vienna

State/Province

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

LKH Salzburg and Paracelsus /ID# 126248

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Krankenhaus der Barmherzigen Bruder /ID# 126270

City

St Veit An Der Glan

ZIP/Postal Code

9300

Country

Austria

Facility Name

AZ Maria Middelares /ID# 126194

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

AZ Sint-Lucas /ID# 126242

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven /ID# 126240

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU de Liege /ID# 126241

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

AZ-Delta /ID# 126195

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

University of Alberta /ID# 119022

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

Facility Name

Winnipeg Regional Health Authority /ID# 119015

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

Qe Ii Hsc /Id# 127115

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

London Health Sciences Centre - University Hospital /ID# 119026

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Medicor Research Inc /ID# 119024

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5M4

Country

Canada

Facility Name

Toronto Digestive Disease Asso /ID# 119019

City

Vaughan

State/Province

Ontario

ZIP/Postal Code

L4L 4Y7

Country

Canada

Facility Name

Montreal General Hospital - McGill University Health Center /ID# 119025

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Fakultni Nemocnice Olomouc /ID# 126264

City

Olomouc

State/Province

Olomoucky Kraj

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Nemocnice Ceske Budejovice a.s. /ID# 126266

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

Hepato-Gastroenterologie HK s.r.o. /ID# 126269

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

ISCARE a.s. /ID# 137977

City

Praha 9

ZIP/Postal Code

190 00

Country

Czechia

Facility Name

Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331

City

Usti Nad Labem

ZIP/Postal Code

401 13

Country

Czechia

Facility Name

Herlev Hospital /ID# 127741

City

Herlev

State/Province

Hovedstaden

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Silkeborg Hospital /ID# 126251

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

CHRU Lille - Hopital Claude Huriez /ID# 127743

City

Lille CEDEX

State/Province

Hauts-de-France

ZIP/Postal Code

59045

Country

France

Facility Name

CHU NANCY - Hopital Brabois Adultes /ID# 127742

City

Vandoeuvre les Nancy CEDEX

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54511

Country

France

Facility Name

CHU Amiens-Picardie Site Sud /ID# 126237

City

Amiens CEDEX 1

State/Province

Somme

ZIP/Postal Code

80054

Country

France

Facility Name

Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Hopital l'Archet 2 /ID# 126238

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

CHU de Saint-Etienne, Hopital Nord /ID# 134450

City

SAINT-ETIENNE Cedex 1

ZIP/Postal Code

42270

Country

France

Facility Name

Hopital Rangueil /ID# 126239

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Universitaetsklinikum Schleswig-Holstein /ID# 126260

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Charite Universitaetsmedizin Berlin /ID# 126196

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257

City

Berlin

ZIP/Postal Code

10318

Country

Germany

Facility Name

Israelitisches Krankenhaus Hamburg /ID# 136549

City

Hamburg

ZIP/Postal Code

22297

Country

Germany

Facility Name

Asklepios Westklinikum Hamburg /ID# 126275

City

Hamburg

ZIP/Postal Code

22559

Country

Germany

Facility Name

Universitaetsklinikum Jena /ID# 126261

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

EUGASTRO GmbH /ID# 126259

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitatsklinikum Magdeburg /ID# 126256

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Gastro Campus Research GbR /ID# 126274

City

Munster

ZIP/Postal Code

48159

Country

Germany

Facility Name

Semmelweis Egyetem /ID# 137896

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Magyar Elhizastudomanyi KKft. /ID# 126276

City

Budapest

ZIP/Postal Code

1124

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

University of Szeged /ID# 126263

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Rabin Medical Center /ID# 126198

City

Petakh Tikva

State/Province

Tel-Aviv

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Soroka University Medical Center /ID# 126243

City

Be'er Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Gastroenterology Institute, Division of Medicine /ID# 126245

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Kaplan Medical Center /ID# 126246

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745

City

Rome

State/Province

Lazio

ZIP/Postal Code

00152

Country

Italy

Facility Name

Policlinico Agostino Gemelli /ID# 127746

City

Rome

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221

City

Milan

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Azienda Ospedaliera Spedali Civili /ID# 127744

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Azienda Ospedaliera di Padova /ID# 126267

City

Padua

ZIP/Postal Code

35128

Country

Italy

Facility Name

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856

City

San Giovanni Rotondo

ZIP/Postal Code

71013

Country

Italy

Facility Name

Academisch Medical center Amsterdam /ID# 126227

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Erasmus Medisch Centrum /ID# 126228

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Sint Franciscus Gasthuis /ID# 127877

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Endoterapia PFG sp. z o.o. /ID# 126199

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-653

Country

Poland

Facility Name

Centrum Endoskopii Zabiegowej /ID# 126272

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271

City

Czestochowa

ZIP/Postal Code

42-200

Country

Poland

Facility Name

KO-Med Centra Kliniczne Pulawi /ID# 126278

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

NZOZ Vivamed /ID# 126255

City

Warsaw

ZIP/Postal Code

03-580

Country

Poland

Facility Name

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Institutul Clinic Fundeni /ID# 127747

City

Sector 2

State/Province

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Tvm Med Serv Srl /Id# 126268

City

Cluj

ZIP/Postal Code

400132

Country

Romania

Facility Name

Cabinet Medical Dr. Fratila SRL /ID# 126247

City

Oradea

ZIP/Postal Code

410167

Country

Romania

Facility Name

Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224

City

Zalau

ZIP/Postal Code

450117

Country

Romania

Facility Name

Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262

City

Bratislava

ZIP/Postal Code

831 04

Country

Slovakia

Facility Name

Gastroenterologicka ambulancia /ID# 137964

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748

City

Lucenec

ZIP/Postal Code

984 01

Country

Slovakia

Facility Name

Poliklinika Libris /ID# 126222

City

Nove Mesto Nad Vahom

ZIP/Postal Code

915 01

Country

Slovakia

Facility Name

Hospital Parc Tauli de Sabadell /ID# 138124

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Hospital Clinic /ID# 127749

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Hospital de Leon /ID# 141675

City

Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Hospital Clinico Universitario San Carlos /ID# 126253

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Complejo Hospitalario Universitario de Pontevedra /ID# 138126

City

Pontevedra

ZIP/Postal Code

36071

Country

Spain

Facility Name

Hospital Clinico Universitario Lozano Blesa /ID# 126252

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Kantonsspital St. Gallen /ID# 127750

City

St. Gallen

State/Province

Sankt Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Universitaetsspital Zuerich /ID# 127751

City

Zurich

State/Province

Zuerich

ZIP/Postal Code

8006

Country

Switzerland

Facility Name

State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753

City

Kharkiv

State/Province

Kharkivska Oblast

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754

City

Kherson

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

Kyiv City Clinical Hospital No.8 /ID# 126232

City

Kiev

ZIP/Postal Code

04201

Country

Ukraine

Facility Name

Lviv Regional Clinical Hospital /ID# 126234

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

Public Institution 6th City Clinical Hospital /ID# 126236

City

Zaporizhzhia

ZIP/Postal Code

69035

Country

Ukraine

Facility Name

Guy's and St Thomas' NHS Found /ID# 144366

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Norfolk and Norwich Univ Hosp /ID# 126197

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Hull University Teaching Hospitals NHS Trustust /ID# 126265

City

Hull

ZIP/Postal Code

HU8 9HE

Country

United Kingdom

Facility Name

University Hospital Southampton NHS Fundation Trust /ID# 126225

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

The Royal Wolverhampton NHS Tr /ID# 126201

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

35122766

Citation

D'Haens GR, Sandborn WJ, Loftus EV Jr, Hanauer SB, Schreiber S, Peyrin-Biroulet L, Panaccione R, Panes J, Baert F, Colombel JF, Ferrante M, Louis E, Armuzzi A, Zhou Q, Goteti VS, Mostafa NM, Doan TT, Petersson J, Finney-Hayward T, Song AP, Robinson AM, Danese S. Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results. Gastroenterology. 2022 Jun;162(7):1876-1890. doi: 10.1053/j.gastro.2022.01.044. Epub 2022 Feb 3.

Results Reference

derived

PubMed Identifier

34402466

Citation

Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.

Results Reference

derived

Links:

URL

http://rxabbvie.com/

Description

Related Info

Learn more about this trial

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

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