Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
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
2 other identifiers
interventional
514
20 countries
143
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2014
Longer than P75 for phase_3
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedResults Posted
Study results publicly available
February 18, 2021
CompletedFebruary 18, 2021
February 1, 2021
5.8 years
February 17, 2014
January 20, 2021
February 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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 Outcomes (15)
Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12
Week 4 and Week 12
Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12
Week 12
Percentage of Participants With Clinical Remission at Week 12
Week 12
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline
Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Week 12
- +10 more secondary outcomes
Study Arms (4)
Induction: Standard Induction Dose
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALAt 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (143)
Birmingham Gastroenterology Associates O.C /ID# 137282
Birmingham, Alabama, 35209, United States
Digestive Health Specialists of the Southeast /ID# 122483
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
KH der Elisabethinen Linz GmbH /ID# 126280
Linz, Upper Austria, 4010, Austria
Medizinische Universitat Wien /ID# 126279
Vienna, Vienna, 1090, 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, Olomoucký kraj, 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, București, 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, Kharkivs’ka 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
Related Publications (6)
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.
PMID: 40202488DERIVEDReppell 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.
PMID: 39162746DERIVEDVerstockt 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.
PMID: 37801628DERIVEDPonce-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.
PMID: 36905528DERIVEDD'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.
PMID: 35122766DERIVEDGreener 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.
PMID: 34402466DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
May 1, 2014
Primary Completion
January 30, 2020
Study Completion
January 30, 2020
Last Updated
February 18, 2021
Results First Posted
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- 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.
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.