An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis
BALANCE-EXTEND
Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494)
2 other identifiers
interventional
493
18 countries
124
Brief Summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Jan 2014
Longer than P75 for phase_2 rheumatoid-arthritis
124 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
Study Start
First participant enrolled
January 24, 2014
CompletedFirst Submitted
Initial submission to the registry
January 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2021
CompletedResults Posted
Study results publicly available
July 12, 2022
CompletedJuly 12, 2022
June 1, 2022
7.5 years
January 28, 2014
June 15, 2022
June 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination
Secondary Outcomes (22)
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
- +17 more secondary outcomes
Study Arms (1)
Upadacitinib
EXPERIMENTALParticipants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). Participants who did not achieve a 20% improvement from RCT Baseline in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 6 or Week 12 were up-titrated to 12 mg BID. From January 2017 participants were transitioned to a once-daily (QD) regimen of upadacitinib, either 15 mg QD (participants who were taking 6 mg BID) or 30 mg QD (participants taking 12 mg BID). Starting with Protocol Amendment 5 participants receiving 30 mg QD upadacitinib had the option to decrease the dose to 15 mg QD at the investigator's discretion. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
Interventions
Administered by intramuscular injection
Eligibility Criteria
You may qualify if:
- Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria.
- If the subject has evidence of new latent tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks (or per local guidelines, whichever is longer) of an ongoing TB prophylaxis before continuing to receive study drug.
- If female, subject must be postmenopausal, OR permanently surgically sterile, OR for women of childbearing potential practicing at least one protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
- Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
- Substudy:
- Must currently be enrolled in the main study.
- Must have been receiving a stable dose of upadacitinib (either 15 mg QD or 30 mg QD) for a minimum of 4 weeks prior to the Vaccination visit.
- Must have been on a stable dose of background methotrexate (no change in dose or frequency) for a minimum of 4 weeks prior to the Vaccination visit.
- If subject is on corticosteroids, must remain on a stable dose of ≤ 10 mg/day of prednisone or equivalent corticosteroid therapy for at least 4 weeks after the vaccination visit.
- Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine.
- Willing to receive Prevnar13® vaccine.
You may not qualify if:
- Pregnant or breastfeeding female.
- Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated.
- Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
- Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria:
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) \> 3.0 × upper limit of normal (ULN)
- Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \< 40 mL/min/1.73m\^2
- Total white blood cell count (WBC) \< 2,000/μL
- Absolute neutrophil count (ANC) \< 1,000/μL
- Platelet count \< 50,000/μL
- Absolute lymphocytes count \< 500/μL
- Hemoglobin \< 8 g/dL
- Enrollment in another interventional clinical study while participating in this study.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
- Substudy:
- Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (124)
Rheum Assoc of North Alabama /ID# 135926
Huntsville, Alabama, 35801, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 135902
Phoenix, Arizona, 85032-9306, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 135931
Phoenix, Arizona, 85032-9306, United States
C.V. Mehta MD, Med Corporation /ID# 124092
Hemet, California, 92543, United States
Moores Cancer Center at UC San Diego /ID# 128747
La Jolla, California, 92093, United States
Desert Medical Advances - Palm Desert /ID# 135911
Palm Desert, California, 92260, United States
Orrin Troum, M.D. and Medical /ID# 135933
Santa Monica, California, 90404, United States
Duplicate_Robin K. Dore MD, Inc /ID# 135906
Tustin, California, 92780, United States
Inland Rheum Clin Trials Inc. /ID# 136716
Upland, California, 91786, United States
Duplicate_Desert Valley Medical Group /ID# 135932
Victorville, California, 92395, United States
Denver Arthritis Clinic /ID# 135901
Denver, Colorado, 80230, United States
New England Research Associates, LLC /ID# 124085
Bridgeport, Connecticut, 06606-1827, United States
Arthritis & Rheumatic Disease Specialties /ID# 135910
Aventura, Florida, 33180, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082
Boca Raton, Florida, 33486, United States
Omega Research Maitland, LLC /ID# 124094
DeBary, Florida, 32713-2260, United States
University of Florida /ID# 124087
Jacksonville, Florida, 32209, United States
Suncoast Research Group /ID# 137774
Miami, Florida, 33135, United States
Omega Research Maitland, LLC /ID# 137398
Orlando, Florida, 32808, United States
Millennium Research /ID# 135917
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc. /ID# 124090
Palm Harbor, Florida, 34684, United States
IRIS Research and Development, LLC /ID# 140362
Plantation, Florida, 33324, United States
Lovelace Scientific Resources /ID# 128745
Venice, Florida, 34292, United States
North Georgia Rheumatology Group /ID# 128746
Lawrenceville, Georgia, 30045, United States
Kansas City Internal Medicine /ID# 135916
Overland Park, Kansas, 66209, United States
PRN Professional Research Network of Kansas, LLC /ID# 124091
Wichita, Kansas, 67205, United States
Klein and Associates MD - Hagerstown /ID# 124086
Hagerstown, Maryland, 21742, United States
The Center for Rheumatology and Bone Research /ID# 124077
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group /ID# 124079
Worcester, Massachusetts, 01605, United States
June DO, PC /ID# 124081
Lansing, Michigan, 48910, United States
Summit Medical Group /ID# 124076
Clifton, New Jersey, 07012-1647, United States
Arthritis and Osteoporosis Associates /ID# 135907
Freehold, New Jersey, 07728-8307, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913
Voorhees Township, New Jersey, 08043, United States
Arthritis and Osteo Assoc /ID# 132280
Las Cruces, New Mexico, 88011, United States
DJL Clinical Research, PLLC /ID# 131936
Charlotte, North Carolina, 28210-8508, United States
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921
Cincinnati, Ohio, 45242-4468, United States
STAT Research, Inc. /ID# 134906
Vandalia, Ohio, 45377-9464, United States
Health Research of Oklahoma /ID# 135904
Oklahoma City, Oklahoma, 73103-2400, United States
Duplicate_East Penn Rheumatology Assoc /ID# 135920
Bethlehem, Pennsylvania, 18015, United States
Altoona Ctr Clinical Res /ID# 124089
Duncansville, Pennsylvania, 16635, United States
Emkey Arthritis and Osteoporosis Clinic /ID# 135908
Wyomissing, Pennsylvania, 19610, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080
Summerville, South Carolina, 29486-7887, United States
Dr. Ramesh Gupta /ID# 128744
Memphis, Tennessee, 38119, United States
Austin Rheumatology Research /ID# 124083
Austin, Texas, 78705, United States
Accurate Clinical Management /ID# 128751
Baytown, Texas, 77521, United States
Accurate Clinical Management /ID# 128752
Houston, Texas, 77004, United States
Baylor College of Medicine - Baylor Medical Center /ID# 135905
Houston, Texas, 77030-3411, United States
Houston Institute for Clin Res /ID# 135912
Houston, Texas, 77074, United States
Accurate Clinical Research /ID# 128753
Houston, Texas, 77089, United States
Accurate Clinical Research /ID# 128754
Houston, Texas, 77089, United States
SW Rheumatology Res. LLC /ID# 135927
Mesquite, Texas, 75150, United States
Mountain State Clinical Research /ID# 124088
Clarksburg, West Virginia, 26301, United States
Aurora Rheumatology and Immunotherapy Center /ID# 135922
Franklin, Wisconsin, 53132, United States
UCL Saint-Luc /ID# 139348
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
ReumaClinic Genk-Hasselt /ID# 137775
Genk, 3600, Belgium
MHAT Trimontsium /ID# 135328
Plovdiv, 4000, Bulgaria
Duplicate_MHAT Kaspela /ID# 136212
Plovdiv, 4001, Bulgaria
UHMAT Palmed Plovdiv /ID# 135355
Plovdiv, 4002, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 135678
Sofia, 1431, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 136210
Sofia, 1431, Bulgaria
Diagnostic Consultative Center /ID# 136736
Sofia, 1612, Bulgaria
Diagnostic consultative center Equita /ID# 136209
Varna, 9000, Bulgaria
Corporacion de Beneficiencia Osorno /ID# 136189
Osorno, Los Lagos Region, 1710216, Chile
Quantum Research /ID# 136188
Puerto Varas, Los Lagos Region, 5550170, Chile
Duplicate_Artroscan s.r.o. /ID# 139347
Ostrava, 722 00, Czechia
L.K.N. Arthrocentrum, s.r.o /ID# 128782
Petřkovice, 725 29, Czechia
Revmatologicky ustav v Praze /ID# 137937
Prague, 128 00, Czechia
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776
Prague, 140 00, Czechia
Revmatologie Bruntal, s.r.o /ID# 137782
Prostějov, 796 01, Czechia
Qualiclinic Kft. /ID# 134170
Budapest, Pest County, 1036, Hungary
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785
Budapest, 1023, Hungary
Szent Margit Szakrendelo /ID# 136676
Budapest, 1032, Hungary
MAV Korhaz ess Rendelointezet /ID# 139971
Szolnok, 5000, Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784
Veszprém, 8200, Hungary
The Chaim Sheba Medical Center /ID# 139295
Ramat Gan, Tel Aviv, 5265601, Israel
Barzilai Medical Center /ID# 140199
Ashkelon, 7830604, Israel
M & M Centrs LTD /ID# 132439
Ādaži, LV-2164, Latvia
Arija's Ancane's Family Doctor Practice /ID# 132437
Baldone, LV-2125, Latvia
Clinic ORTO /ID# 132438
Riga, LV-1005, Latvia
Clinstile, S.A. de C.V. /ID# 137075
Cuauhtémoc, Mexico City, 20313, Mexico
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307
Mexico City, 06090, Mexico
Cliditer SA de CV /ID# 136876
Mexico City, 06700, Mexico
Timaru Medical Specialists Ltd /ID# 131909
Timaru, Canterbury, 7910, New Zealand
Waikato Hospital /ID# 131908
Hamilton, Waikato Region, 3240, New Zealand
Porter Rheumatology Ltd /ID# 133983
Nelson, 7010, New Zealand
Prywatna Praktyka Lekarska /ID# 128837
Poznan, Greater Poland Voivodeship, 61-397, Poland
Pratia MCM Krakow /ID# 134749
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Reum-Medica S.C. /ID# 128841
Wroclaw, Lower Silesian Voivodeship, 50-244, Poland
Twoja Przychodnia Centrum Medyczne /ID# 128840
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
NZOZ Lecznica MAK-MED s.c. /ID# 128838
Nadarzyn, Masovian Voivodeship, 05-830, Poland
Medicome sp. z o.o. /ID# 137397
Oswiecim, Masovian Voivodeship, 32-600, Poland
NBR Polska /ID# 136208
Warsaw, Masovian Voivodeship, 00-465, Poland
Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835
Warsaw, Masovian Voivodeship, 01-518, Poland
Centrum Medyczne Pratia Warszawa /ID# 136650
Warsaw, Masovian Voivodeship, 01-868, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 140198
Warsaw, Masovian Voivodeship, 02-691, Poland
Gabinet Internistyczno-Reumatologiczny /ID# 135876
Bialystok, Podlaskie Voivodeship, 15-077, Poland
Centrum Medyczne Pratia Gdynia /ID# 137362
Gdynia, Pomeranian Voivodeship, 81-338, Poland
Ambulatorium Sp. z o.o /ID# 138074
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Duplicate_REUMED Filia nr 2 /ID# 128839
Lublin, 20-582, Poland
Dr. Ramon L. Ortega-Colon, MD /ID# 128760
Carolina, 00983, Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 128759
San Juan, 00917-3104, Puerto Rico
Mindful Medical Research /ID# 136211
San Juan, 00918-3756, Puerto Rico
Kazan State Medical University /ID# 136734
Kazan', Tatarstan, Respublika, 420012, Russia
Tver Regional Clinical Hospital /ID# 137576
Tver', Tver Oblast, 170036, Russia
St. Petersburg Research Institute of Emergency Medicine n.а. I. I. Dzhanelidze /ID# 136652
Saint Petersburg, 192242, Russia
MEDMAN s.r.o. /ID# 136649
Martin, 036 01, Slovakia
Poliklinika Senica n.o. /ID# 134728
Senica, 905 01, Slovakia
Dr MJ Prins /ID# 138540
Cape Town, Western Cape, 7500, South Africa
Winelands Medical Research Centre /ID# 134669
Stellenbosch, Western Cape, 7600, South Africa
Clinica Gaias /ID# 133868
Santiago de Compostela, A Coruna, 15702, Spain
Hospital General Universitario de Elche /ID# 128851
Elche, Alicante, 03203, Spain
Hospital Infanta Sofia /ID# 136653
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Regional de Malaga /ID# 128847
Málaga, Malaga, 29010, Spain
Hospital Universitario A Coruna - CHUAC /ID# 128846
A Coruña, 15006, Spain
Hospital CIMA Sanitas /ID# 128849
Barcelona, 08034, Spain
Hospital Clinico Universitario San Carlos /ID# 128852
Madrid, 28040, Spain
Hospital Universitario Virgen Macarena /ID# 128853
Seville, 41009, Spain
Hospital QuironSalud Infanta Luisa /ID# 135689
Seville, 41010, Spain
Hospital Universitario Virgen de Valme /ID# 134668
Seville, 41014, Spain
NSC Strazhesko Ist Cardiology /ID# 137330
Kiev, 03680, Ukraine
Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334
Kyiv, 02125, Ukraine
Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514
Warrington, Cheshire West And Chester, WA5 1QG, United Kingdom
Barts Health NHS Trust /ID# 135683
London, London, City of, E1 2ES, United Kingdom
West Suffolk Hospital /ID# 128858
Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom
Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308
Leeds, LS9 7TF, United Kingdom
Related Publications (3)
Baraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Li Y, Bu X, Shmagel A, Wung P, Song IH, Deodhar A. Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study. Arthritis Res Ther. 2023 Sep 18;25(1):172. doi: 10.1186/s13075-023-03128-1.
PMID: 37723577DERIVEDKivitz A, Wells AF, Vargas JI, Baraf HSB, Rischmueller M, Klaff J, Khan N, Li Y, Carter K, Friedman A, Durez P. Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study. Rheumatol Ther. 2023 Aug;10(4):901-915. doi: 10.1007/s40744-023-00557-x. Epub 2023 May 18.
PMID: 37199884DERIVEDWinthrop K, Vargas JI, Drescher E, Garcia C, Friedman A, Hendrickson B, Li Y, Klaff J, Kivitz A. Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study. RMD Open. 2022 Mar;8(1):e002110. doi: 10.1136/rmdopen-2021-002110.
PMID: 35246470DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2014
First Posted
January 30, 2014
Study Start
January 24, 2014
Primary Completion
July 29, 2021
Study Completion
July 29, 2021
Last Updated
July 12, 2022
Results First Posted
July 12, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- 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 Use Agreement (DUA). 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.