Clinical trial NCT02049138: An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Musculoskeletal Disease
Arthritis
Joint Diseases
Anti-inflammatory Agents
Antirheumatic agents
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib.

All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing.

An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020.

In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) with upadacitinib (ABT-494) and did not develop any discontinuation criteria.
2. 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.
3. 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.
4. 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:

1. Must currently be enrolled in the main study.
2. 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.
3. 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.
4. 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.
5. Must meet the prescribing specifications as per local label requirements to receive Prevnar 13® vaccine.
6. Willing to receive Prevnar13® vaccine.

Exclusion Criteria:

1. Pregnant or breastfeeding female.
2. 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.
3. Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
4. 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
5. Enrollment in another interventional clinical study while participating in this study.
6. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.

Substudy:

1. Receiving any conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than methotrexate
2. Receiving \> 10 mg/day of prednisone or equivalent corticosteroid therapy.
3. Receipt of any steroid injection within 4 weeks prior to Vaccination visit.
4. History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®.
5. History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit.
6. Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit.
7. Receipt of any pneumococcal vaccine.
8. Subject is not suitable for the sub-study as per the Investigator's judgment.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
timeFrame: 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
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
timeFrame: 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
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
timeFrame: 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
measure: Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
timeFrame: 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:
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
timeFrame: 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
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
timeFrame: 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
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
timeFrame: 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
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
timeFrame: 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
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
timeFrame: 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
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
timeFrame: 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
measure: Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
timeFrame: 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
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
timeFrame: 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
measure: Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
timeFrame: 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
measure: Change From Baseline in Tender Joint Count (TJC68) Over Time
timeFrame: 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
measure: Change From Baseline in Swollen Joint Count (SJC66) Over Time
timeFrame: 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
measure: Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
timeFrame: 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
measure: Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
timeFrame: 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
measure: Change From Baseline in Patient's Assessment of Pain Over Time
timeFrame: 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
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
timeFrame: 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
measure: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
timeFrame: 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
measure: Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
timeFrame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
measure: Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
timeFrame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
measure: Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
timeFrame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
measure: Change From Baseline in EuroQoL-5D VAS Score Over Time
timeFrame: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
measure: Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination
timeFrame: Vaccination Baseline and 12 weeks after vaccination
measure: Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
timeFrame: Vaccination Baseline and 4 and 12 weeks after vaccination
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheum Assoc of North Alabama /ID# 135926
state: Alabama
city: Phoenix
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 135902
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 135931
state: Arizona
city: Hemet
country: United States
facility: C.V. Mehta MD, Med Corporation /ID# 124092
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center at UC San Diego /ID# 128747
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances - Palm Desert /ID# 135911
state: California
city: Santa Monica
country: United States
facility: Orrin Troum, M.D. and Medical /ID# 135933
state: California
city: Tustin
country: United States
facility: Duplicate_Robin K. Dore MD, Inc /ID# 135906
state: California
city: Upland
country: United States
facility: Inland Rheum Clin Trials Inc. /ID# 136716
state: California
city: Victorville
country: United States
facility: Duplicate_Desert Valley Medical Group /ID# 135932
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 135901
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC /ID# 124085
state: Connecticut
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties /ID# 135910
state: Florida
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082
state: Florida
city: DeBary
country: United States
facility: Omega Research Maitland, LLC /ID# 124094
state: Florida
city: Jacksonville
country: United States
facility: University of Florida /ID# 124087
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group /ID# 137774
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland, LLC /ID# 137398
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research /ID# 135917
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 124090
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC /ID# 140362
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources /ID# 128745
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group /ID# 128746
state: Georgia
city: Overland Park
country: United States
facility: Kansas City Internal Medicine /ID# 135916
state: Kansas
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 124091
state: Kansas
city: Hagerstown
country: United States
facility: Klein and Associates MD - Hagerstown /ID# 124086
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research /ID# 124077
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group /ID# 124079
state: Massachusetts
city: Lansing
country: United States
facility: June DO, PC /ID# 124081
state: Michigan
city: Clifton
country: United States
facility: Summit Medical Group /ID# 124076
state: New Jersey
city: Freehold
country: United States
facility: Arthritis and Osteoporosis Associates /ID# 135907
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913
state: New Jersey
city: Las Cruces
country: United States
facility: Arthritis and Osteo Assoc /ID# 132280
state: New Mexico
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 131936
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921
state: Ohio
city: Vandalia
country: United States
facility: STAT Research, Inc. /ID# 134906
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma /ID# 135904
state: Oklahoma
city: Bethlehem
country: United States
facility: Duplicate_East Penn Rheumatology Assoc /ID# 135920
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 124089
state: Pennsylvania
city: Wyomissing
country: United States
facility: Emkey Arthritis and Osteoporosis Clinic /ID# 135908
state: Pennsylvania
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080
state: South Carolina
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 128744
state: Tennessee
city: Austin
country: United States
facility: Austin Rheumatology Research /ID# 124083
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management /ID# 128751
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management /ID# 128752
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center /ID# 135905
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clin Res /ID# 135912
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research /ID# 128753
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research /ID# 128754
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Res. LLC /ID# 135927
state: Texas
city: Clarksburg
country: United States
facility: Mountain State Clinical Research /ID# 124088
state: West Virginia
city: Franklin
country: United States
facility: Aurora Rheumatology and Immunotherapy Center /ID# 135922
state: Wisconsin
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 139348
state: Bruxelles-Capitale
city: Genk
country: Belgium
facility: ReumaClinic Genk-Hasselt /ID# 137775
city: Plovdiv
country: Bulgaria
facility: MHAT Trimontsium /ID# 135328
city: Plovdiv
country: Bulgaria
facility: Duplicate_MHAT Kaspela /ID# 136212
city: Plovdiv
country: Bulgaria
facility: UHMAT Palmed Plovdiv /ID# 135355
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 135678
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 136210
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center /ID# 136736
city: Varna
country: Bulgaria
facility: Diagnostic consultative center Equita /ID# 136209
city: Osorno
country: Chile
facility: Corporacion de Beneficiencia Osorno /ID# 136189
state: Los Lagos
city: Puerto Varas
country: Chile
facility: Quantum Research /ID# 136188
state: Los Lagos
city: Ostrava
country: Czechia
facility: Duplicate_Artroscan s.r.o. /ID# 139347
city: Petrkovice
country: Czechia
facility: L.K.N. Arthrocentrum, s.r.o /ID# 128782
city: Praha
country: Czechia
facility: Revmatologicky ustav v Praze /ID# 137937
city: Praha
country: Czechia
facility: Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776
city: Prostejov
country: Czechia
facility: Revmatologie Bruntal, s.r.o /ID# 137782
city: Budapest
country: Hungary
facility: Qualiclinic Kft. /ID# 134170
state: Pest
city: Budapest
country: Hungary
facility: Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785
city: Budapest
country: Hungary
facility: Szent Margit Szakrendelo /ID# 136676
city: Szolnok
country: Hungary
facility: MAV Korhaz ess Rendelointezet /ID# 139971
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 139295
state: Tel-Aviv
city: Ashkelon
country: Israel
facility: Barzilai Medical Center /ID# 140199
city: Adazi
country: Latvia
facility: M & M Centrs LTD /ID# 132439
city: Baldone
country: Latvia
facility: Arija's Ancane's Family Doctor Practice /ID# 132437
city: Riga
country: Latvia
facility: Clinic ORTO /ID# 132438
city: Cuauhtemoc
country: Mexico
facility: Clinstile, S.A. de C.V. /ID# 137075
state: Ciudad De Mexico
city: Mexico City
country: Mexico
facility: Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307
city: Mexico City
country: Mexico
facility: Cliditer SA de CV /ID# 136876
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 131909
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 131908
state: Waikato
city: Nelson
country: New Zealand
facility: Porter Rheumatology Ltd /ID# 133983
city: Wroclaw
country: Poland
facility: Reum-Medica S.C. /ID# 128841
state: Dolnoslaskie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Centrum Medyczne /ID# 128840
state: Lubuskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 134749
state: Malopolskie
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c. /ID# 128838
state: Mazowieckie
city: Oswiecim
country: Poland
facility: Medicome sp. z o.o. /ID# 137397
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne Pratia Warszawa /ID# 136650
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne Reuma Park w Warszawie /ID# 140198
state: Mazowieckie
city: Warszawa
country: Poland
facility: NBR Polska /ID# 136208
state: Mazowieckie
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny /ID# 135876
state: Podlaskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia /ID# 137362
state: Pomorskie
city: Elblag
country: Poland
facility: Ambulatorium Sp. z o.o /ID# 138074
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska /ID# 128837
state: Wielkopolskie
city: Lublin
country: Poland
facility: Duplicate_REUMED Filia nr 2 /ID# 128839
city: Carolina
country: Puerto Rico
facility: Dr. Ramon L. Ortega-Colon, MD /ID# 128760
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC - Hato Rey /ID# 128759
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 136211
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 136734
state: Tatarstan, Respublika
city: Tver
country: Russian Federation
facility: Tver Regional Clinical Hospital /ID# 137576
state: Tverskaya Oblast
city: Sankt-Peterburg
country: Russian Federation
facility: St. Petersburg Research Institute of Emergency Medicine n.а. I. I. Dzhanelidze /ID# 136652
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. /ID# 136649
city: Senica
country: Slovakia
facility: Poliklinika Senica n.o. /ID# 134728
city: Cape Town
country: South Africa
facility: Dr MJ Prins /ID# 138540
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre /ID# 134669
state: Western Cape
city: Santiago de Compostela
country: Spain
facility: Clinica Gaias /ID# 133868
state: A Coruna
city: Elche
country: Spain
facility: Hospital General Universitario de Elche /ID# 128851
state: Alicante
city: San Sebastián de Los Reyes
country: Spain
facility: Hospital Infanta Sofia /ID# 136653
state: Madrid
city: Málaga
country: Spain
facility: Hospital Regional de Malaga /ID# 128847
state: Malaga
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna - CHUAC /ID# 128846
city: Barcelona
country: Spain
facility: Hospital CIMA Sanitas /ID# 128849
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 128852
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 128853
city: Sevilla
country: Spain
facility: Hospital QuironSalud Infanta Luisa /ID# 135689
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme /ID# 134668
city: Kiev
country: Ukraine
facility: NSC Strazhesko Ist Cardiology /ID# 137330
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334
city: Warrington
country: United Kingdom
facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514
state: Cheshire West And Chester
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 135683
state: London, City Of
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital /ID# 128858
state: Suffolk
city: Leeds
country: United Kingdom
facility: Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Winthrop 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.