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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001746-33 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction: Standard Induction Dose | Experimental | 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. |
|
| Induction: Higher Induction Dose | Experimental | 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. |
|
| Maintenance: Clinically Adjusted (CA) Regimen | Experimental | 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. |
|
| Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gastroenterology Associates O.C /ID# 137282 | Birmingham | Alabama | 35209 | United States | ||
| Digestive Health Specialists of the Southeast /ID# 122483 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40202488 | Derived | Battat R, Kandi S, Lacerda AP, Levine P, Neimark E, Feagan BG, Rubin DT, Ji QC, Chen X, Polakow SB. Association of bile acid diarrhea with symptoms and disease activity in Crohn's disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn's disease. J Crohns Colitis. 2025 May 8;19(5):jjaf053. doi: 10.1093/ecco-jcc/jjaf053. | |
| 39162746 |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
Participants were randomized in a 3:2 ratio at Baseline to receive a higher induction adalimumab regimen or standard induction adalimumab regimen during the double-blind Induction Study. At Week 12, participants were re-randomized in a 1:1 ratio to a double-blind exploratory treatment regimen (adalimumab clinically adjusted [CA] regimen or adalimumab therapeutic drug monitoring [TDM] regimen).
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction: Standard Induction Dose | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2018 | Jan 20, 2021 |
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| Placebo | Drug |
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| 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). |
| 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 |
| 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 |
| 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 |
| 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 |
| Change From Baseline in Fecal Calprotectin Level at Week 4 | Baseline, Week 4 |
| Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4 | Week 4 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Moore UC San Diego Cancer Center /ID# 119053 | La Jolla | California | 92093 | United States |
| Axis Clinical Trials /ID# 130390 | Los Angeles | California | 90036 | United States |
| Rocky Mountain Gastroenterology /ID# 119038 | Wheat Ridge | Colorado | 80033 | United States |
| Medical Research Ctr CT /ID# 119037 | Hamden | Connecticut | 06518 | United States |
| Gastroenterology Group Naples /ID# 122493 | Naples | Florida | 34102 | United States |
| Internal Med Specialists /ID# 137737 | Orlando | Florida | 32806 | United States |
| Shafran Gastroenterology Ctr /ID# 119057 | Winter Park | Florida | 32789 | United States |
| Winship Cancer Institute of Emory University /ID# 136851 | Atlanta | Georgia | 30322 | United States |
| Atlanta Gastro Assoc /ID# 119065 | Atlanta | Georgia | 30342 | United States |
| Gastroenterology Associates of Central Georgia, LLC /ID# 119056 | Macon | Georgia | 31201 | United States |
| Northwestern University Feinberg School of Medicine /ID# 119043 | Chicago | Illinois | 60611-2927 | United States |
| University of Chicago DCAM /ID# 119077 | Chicago | Illinois | 60637-1443 | United States |
| Carle Foundation Hospital Digestive Health Research Center /ID# 136008 | Urbana | Illinois | 61801 | United States |
| Louisana Research Center, LLC /ID# 136749 | Shreveport | Louisiana | 71105-6800 | United States |
| Investigative Clinical Research /ID# 119033 | Annapolis | Maryland | 21228 | United States |
| MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042 | Chevy Chase | Maryland | 20815 | United States |
| Commonwealth Clinical Studies /ID# 136850 | Brockton | Massachusetts | 02302 | United States |
| University of Michigan Health Systems /ID# 119076 | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Gastroenterology, P. A. /ID# 137280 | Plymouth | Minnesota | 55446 | United States |
| Mayo Clinic /ID# 122489 | Rochester | Minnesota | 55905-0001 | United States |
| Kansas City Research Institute /ID# 119034 | Kansas City | Missouri | 64131 | United States |
| Ctr for Digest and Liver Dis /ID# 119040 | Mexico | Missouri | 65265 | United States |
| Albany Medical College /ID# 140200 | Albany | New York | 12208 | United States |
| NYU Langone Long Island Clinical Research Associates /ID# 119035 | Great Neck | New York | 11021 | United States |
| The Mount Sinai Hospital /ID# 127116 | New York | New York | 10029 | United States |
| Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041 | Charlotte | North Carolina | 28207 | United States |
| Wake Research Associates, LLC /ID# 119029 | Raleigh | North Carolina | 27612 | United States |
| Consultants for Clinical Res /ID# 119052 | Cincinnati | Ohio | 45219 | United States |
| Gastro United of Tulsa /ID# 122485 | Tulsa | Oklahoma | 74135 | United States |
| The Oregon Clinic, Gastroenterology - West /ID# 135272 | Portland | Oregon | 97225 | United States |
| West Bay Clinical Research /ID# 138330 | Warwick | Rhode Island | 02886 | United States |
| Medical University of South Carolina /ID# 138122 | Charleston | South Carolina | 29425 | United States |
| Erlanger Institute for Clinical Research /ID# 129008 | Chattanooga | Tennessee | 37403 | United States |
| Gastro One /ID# 119068 | Germantown | Tennessee | 38138 | United States |
| Nashville Med Res Inst /ID# 119050 | Nashville | Tennessee | 37205 | United States |
| Vanderbilt Univ Med Ctr /ID# 125501 | Nashville | Tennessee | 37232-0011 | United States |
| Texas Digestive Disease Consultants - Dallas /ID# 138121 | Dallas | Texas | 75231 | United States |
| Baylor College of Medicine /ID# 137277 | Houston | Texas | 77030-3411 | United States |
| Austin Institute for Clinical Research /ID# 125500 | Pflugerville | Texas | 78660 | United States |
| Texas Digestive Disease Consultants - Southlake /ID# 137283 | Southlake | Texas | 76092 | United States |
| Advanced Research Institute /ID# 119048 | Ogden | Utah | 84403 | United States |
| University of Utah /ID# 119062 | Salt Lake City | Utah | 84112-5500 | United States |
| Gastro Assoc of Tidewater /ID# 135897 | Chesapeake | Virginia | 23320 | United States |
| New River Valley Research Inst /ID# 127807 | Christiansburg | Virginia | 24073 | United States |
| Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036 | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert Memorial Lutheran Hospital /ID# 119081 | Milwaukee | Wisconsin | 53226-3522 | United States |
| Medizinische Universitat Wien /ID# 126279 | Vienna | State of Vienna | 1090 | Austria |
| KH der Elisabethinen Linz GmbH /ID# 126280 | Linz | Upper Austria | 4010 | Austria |
| Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249 | Innsbruck | 6020 | Austria |
| LKH Salzburg and Paracelsus /ID# 126248 | Salzburg | 5020 | Austria |
| Krankenhaus der Barmherzigen Bruder /ID# 126270 | Sankt Veit an der Glan | 9300 | Austria |
| AZ Maria Middelares /ID# 126194 | Ghent | 9000 | Belgium |
| AZ Sint-Lucas /ID# 126242 | Ghent | 9000 | Belgium |
| UZ Leuven /ID# 126240 | Leuven | 3000 | Belgium |
| CHU de Liege /ID# 126241 | Liège | 4000 | Belgium |
| AZ-Delta /ID# 126195 | Roeselare | 8800 | Belgium |
| University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017 | Calgary | Alberta | T2N 4Z6 | Canada |
| University of Alberta /ID# 119022 | Edmonton | Alberta | T6G 2X8 | Canada |
| Winnipeg Regional Health Authority /ID# 119015 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Qe Ii Hsc /Id# 127115 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Medicor Research Inc /ID# 119024 | Greater Sudbury | Ontario | P3E 5M4 | Canada |
| London Health Sciences Centre - University Hospital /ID# 119026 | London | Ontario | N6A 5A5 | Canada |
| Toronto Digestive Disease Asso /ID# 119019 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Montreal General Hospital - McGill University Health Center /ID# 119025 | Montreal | Quebec | H3G 1A4 | Canada |
| Fakultni Nemocnice Olomouc /ID# 126264 | Olomouc | Olomouc Region | 779 00 | Czechia |
| Nemocnice Ceske Budejovice a.s. /ID# 126266 | České Budějovice | 370 01 | Czechia |
| Hepato-Gastroenterologie HK s.r.o. /ID# 126269 | Hradec Králové | 500 12 | Czechia |
| ISCARE a.s. /ID# 137977 | Prague | 190 00 | Czechia |
| Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331 | Ústí nad Labem | 401 13 | Czechia |
| Herlev Hospital /ID# 127741 | Herlev | Capital Region | 2730 | Denmark |
| Silkeborg Hospital /ID# 126251 | Silkeborg | 8600 | Denmark |
| CHRU Lille - Hopital Claude Huriez /ID# 127743 | Lille | Hauts-de-France | 59045 | France |
| CHU NANCY - Hopital Brabois Adultes /ID# 127742 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHU Amiens-Picardie Site Sud /ID# 126237 | Amiens | Somme | 80054 | France |
| Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200 | Grenoble | 38043 | France |
| Hopital l'Archet 2 /ID# 126238 | Nice | 06202 | France |
| CHU de Saint-Etienne, Hopital Nord /ID# 134450 | Saint-Etienne | 42270 | France |
| Hopital Rangueil /ID# 126239 | Toulouse | 31059 | France |
| Universitaetsklinikum Schleswig-Holstein /ID# 126260 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charite Universitaetsmedizin Berlin /ID# 126196 | Berlin | 10117 | Germany |
| Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257 | Berlin | 10318 | Germany |
| Israelitisches Krankenhaus Hamburg /ID# 136549 | Hamburg | 22297 | Germany |
| Asklepios Westklinikum Hamburg /ID# 126275 | Hamburg | 22559 | Germany |
| Universitaetsklinikum Jena /ID# 126261 | Jena | 07747 | Germany |
| EUGASTRO GmbH /ID# 126259 | Leipzig | 04103 | Germany |
| Universitatsklinikum Magdeburg /ID# 126256 | Magdeburg | 39120 | Germany |
| Gastro Campus Research GbR /ID# 126274 | Münster | 48159 | Germany |
| Semmelweis Egyetem /ID# 137896 | Budapest | 1085 | Hungary |
| Magyar Elhizastudomanyi KKft. /ID# 126276 | Budapest | 1124 | Hungary |
| Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895 | Pécs | 7624 | Hungary |
| University of Szeged /ID# 126263 | Szeged | 6720 | Hungary |
| Rabin Medical Center /ID# 126198 | Petakh Tikva | Tel Aviv | 4941492 | Israel |
| Soroka University Medical Center /ID# 126243 | Beersheba | 84101 | Israel |
| Gastroenterology Institute, Division of Medicine /ID# 126245 | Jerusalem | 91120 | Israel |
| Kaplan Medical Center /ID# 126246 | Rehovot | 76100 | Israel |
| UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745 | Rome | Lazio | 00152 | Italy |
| Policlinico Agostino Gemelli /ID# 127746 | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221 | Milan | Lombardy | 20122 | Italy |
| IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226 | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Spedali Civili /ID# 127744 | Brescia | 25123 | Italy |
| Azienda Ospedaliera di Padova /ID# 126267 | Padua | 35128 | Italy |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856 | San Giovanni Rotondo | 71013 | Italy |
| Academisch Medical center Amsterdam /ID# 126227 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Erasmus Medisch Centrum /ID# 126228 | Rotterdam | 3015 CE | Netherlands |
| Sint Franciscus Gasthuis /ID# 127877 | Rotterdam | 3045 PM | Netherlands |
| Endoterapia PFG sp. z o.o. /ID# 126199 | Warsaw | Masovian Voivodeship | 02-653 | Poland |
| Centrum Endoskopii Zabiegowej /ID# 126272 | Bydgoszcz | 85-168 | Poland |
| Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271 | Częstochowa | 42-200 | Poland |
| KO-Med Centra Kliniczne Pulawi /ID# 126278 | Puławy | 24-100 | Poland |
| NZOZ Vivamed /ID# 126255 | Warsaw | 03-580 | Poland |
| Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974 | Lodz | Łódź Voivodeship | 90-302 | Poland |
| School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735 | San Juan | 00935 | Puerto Rico |
| Institutul Clinic Fundeni /ID# 127747 | Sector 2 | Bucharest | 022328 | Romania |
| Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277 | Brasov | 500283 | Romania |
| Tvm Med Serv Srl /Id# 126268 | Cluj-Napoca | 400132 | Romania |
| Cabinet Medical Dr. Fratila SRL /ID# 126247 | Oradea | 410167 | Romania |
| Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224 | Zalău | 450117 | Romania |
| Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262 | Bratislava | 831 04 | Slovakia |
| Gastroenterologicka ambulancia /ID# 137964 | Bratislava | 851 01 | Slovakia |
| Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748 | Lučenec | 984 01 | Slovakia |
| Poliklinika Libris /ID# 126222 | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Hospital Parc Tauli de Sabadell /ID# 138124 | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425 | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clinic /ID# 127749 | Barcelona | 08036 | Spain |
| Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976 | Girona | 17007 | Spain |
| Hospital de Leon /ID# 141675 | León | 24071 | Spain |
| Hospital Clinico Universitario San Carlos /ID# 126253 | Madrid | 28040 | Spain |
| Complejo Hospitalario Universitario de Pontevedra /ID# 138126 | Pontevedra | 36071 | Spain |
| Hospital Clinico Universitario Lozano Blesa /ID# 126252 | Zaragoza | 50009 | Spain |
| Kantonsspital St. Gallen /ID# 127750 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Universitaetsspital Zuerich /ID# 127751 | Zurich | Canton of Zurich | 8006 | Switzerland |
| State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753 | Kharkiv | Kharkiv Oblast | 61039 | Ukraine |
| Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754 | Kherson | 73000 | Ukraine |
| Kyiv City Clinical Hospital No.8 /ID# 126232 | Kiev | 04201 | Ukraine |
| Lviv Regional Clinical Hospital /ID# 126234 | Lviv | 79011 | Ukraine |
| Public Institution 6th City Clinical Hospital /ID# 126236 | Zaporizhzhia | 69035 | Ukraine |
| Guy's and St Thomas' NHS Found /ID# 144366 | London | London, City of | SE1 9RT | United Kingdom |
| Norfolk and Norwich Univ Hosp /ID# 126197 | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Hull University Teaching Hospitals NHS Trustust /ID# 126265 | Hull | HU8 9HE | United Kingdom |
| University Hospital Southampton NHS Fundation Trust /ID# 126225 | Southampton | SO16 6YD | United Kingdom |
| The Royal Wolverhampton NHS Tr /ID# 126201 | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Reppell M, Zheng X, Dreher I, Blaes J, Regan E, Haslberger T, Guay H, Pivorunas V, Smaoui N. HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies. J Crohns Colitis. 2025 Jan 11;19(1):jjae129. doi: 10.1093/ecco-jcc/jjae129. |
| 37801628 | Derived | Verstockt B, Pivorunas V, Al Mahi N, Smaoui N, Guay H, Kennedy NA, Goodhand JR, Lin S, Bai BYH, Hanauer SB, Ferrante M, Panes J, Vermeire S. Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies. J Crohns Colitis. 2024 Apr 23;18(4):493-505. doi: 10.1093/ecco-jcc/jjad170. |
| 36905528 | Derived | Ponce-Bobadilla AV, Stodtmann S, Chen MJ, Winzenborg I, Mensing S, Blaes J, Haslberger T, Laplanche L, Dreher I, Mostafa NM. Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis. Clin Pharmacokinet. 2023 Apr;62(4):623-634. doi: 10.1007/s40262-023-01221-x. Epub 2023 Mar 11. |
| 35122766 | Derived | 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. |
| 34402466 | Derived | 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. |
| Induction: Higher Induction Dose |
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. |
| FG002 | Maintenance: Clinically Adjusted (CA) Regimen | Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose could 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. |
| FG003 | Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are 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 receive 40 mg ew. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction: Standard Induction Dose | 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. |
| BG001 | Induction: Higher Induction Dose | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Safety Set: all participants who received at least one injection of study drug. | Posted | Count of Participants | Participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Participants taking corticosteroids at Baseline. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fecal Calprotectin Level at Week 4 | Intent to Treat Population: all participants who were randomized. Participants with a baseline and Week 4 assessment. Observed cases. | Posted | Mean | Standard Deviation | µg/g | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4 | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | 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. | Intent to Treat Population: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 12 |
|
|
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).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Induction: Standard Induction Dose | 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 eow starting at Week 4 through Week 12. | 0 | 206 | 10 | 206 | 54 | 206 |
| EG001 | Induction: Higher Induction Dose | 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. | 0 | 308 | 14 | 308 | 58 | 308 |
| EG002 | Maintenance: Clinically Adjusted (CA) Regimen | Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or 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. | 0 | 109 | 5 | 109 | 41 | 109 |
| EG003 | Maintenance: Therapeutic Drug Management (TDM) Regimen | At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are 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 receive 40 mg ew. | 0 | 109 | 7 | 109 | 33 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SCLERITIS | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ACQUIRED IMMUNODEFICIENCY SYNDROME | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| INFECTIOUS MONONUCLEOSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| INTESTINAL TUBERCULOSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| TRAUMATIC LIVER INJURY | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| PAPILLARY RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| SELECTIVE ABORTION | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2019 | Jan 20, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other, Not Specified |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 |
| Induction: Higher Induction Dose |
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. |
| OG002 | Maintenance: Clinically Adjusted (CA) Regimen | Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or 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. |
| OG003 | Maintenance: Therapeutic Drug Monitoring (TDM) Regimen | At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are 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 receive 40 mg ew. |
|
|
|
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| Induction: Higher Induction Dose |
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. |
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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. |
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| Participants |
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