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An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis (BALANCE-EXTEND)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Upadacitinib

Pneumococcal 13-valent conjugate vaccine (PCV-13)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Musculoskeletal Disease, Arthritis, Joint Diseases, Anti-inflammatory Agents, Antirheumatic agents

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy.
Receipt of any steroid injection within 4 weeks prior to Vaccination visit.
History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®.
History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit.
Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit.
Receipt of any pneumococcal vaccine.
Subject is not suitable for the sub-study as per the Investigator's judgment.

Sites / Locations

Rheum Assoc of North Alabama /ID# 135926
AZ Arthritis and Rheumotology Research, PLLC /ID# 135902
AZ Arthritis and Rheumotology Research, PLLC /ID# 135931
C.V. Mehta MD, Med Corporation /ID# 124092
Moores Cancer Center at UC San Diego /ID# 128747
Desert Medical Advances - Palm Desert /ID# 135911
Orrin Troum, M.D. and Medical /ID# 135933
Duplicate_Robin K. Dore MD, Inc /ID# 135906
Inland Rheum Clin Trials Inc. /ID# 136716
Duplicate_Desert Valley Medical Group /ID# 135932
Denver Arthritis Clinic /ID# 135901
New England Research Associates, LLC /ID# 124085
Arthritis & Rheumatic Disease Specialties /ID# 135910
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082
Omega Research Maitland, LLC /ID# 124094
University of Florida /ID# 124087
Suncoast Research Group /ID# 137774
Omega Research Maitland, LLC /ID# 137398
Millennium Research /ID# 135917
Arthritis Center, Inc. /ID# 124090
IRIS Research and Development, LLC /ID# 140362
Lovelace Scientific Resources /ID# 128745
North Georgia Rheumatology Group /ID# 128746
Kansas City Internal Medicine /ID# 135916
PRN Professional Research Network of Kansas, LLC /ID# 124091
Klein and Associates MD - Hagerstown /ID# 124086
The Center for Rheumatology and Bone Research /ID# 124077
Clinical Pharmacology Study Group /ID# 124079
June DO, PC /ID# 124081
Summit Medical Group /ID# 124076
Arthritis and Osteoporosis Associates /ID# 135907
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913
Arthritis and Osteo Assoc /ID# 132280
DJL Clinical Research, PLLC /ID# 131936
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921
STAT Research, Inc. /ID# 134906
Health Research of Oklahoma /ID# 135904
Duplicate_East Penn Rheumatology Assoc /ID# 135920
Altoona Ctr Clinical Res /ID# 124089
Emkey Arthritis and Osteoporosis Clinic /ID# 135908
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080
Dr. Ramesh Gupta /ID# 128744
Austin Rheumatology Research /ID# 124083
Accurate Clinical Management /ID# 128751
Accurate Clinical Management /ID# 128752
Baylor College of Medicine - Baylor Medical Center /ID# 135905
Houston Institute for Clin Res /ID# 135912
Accurate Clinical Research /ID# 128753
Accurate Clinical Research /ID# 128754
SW Rheumatology Res. LLC /ID# 135927
Mountain State Clinical Research /ID# 124088
Aurora Rheumatology and Immunotherapy Center /ID# 135922
UCL Saint-Luc /ID# 139348
ReumaClinic Genk-Hasselt /ID# 137775
MHAT Trimontsium /ID# 135328
Duplicate_MHAT Kaspela /ID# 136212
UHMAT Palmed Plovdiv /ID# 135355
UMHAT Sveti Ivan Rilski /ID# 135678
UMHAT Sveti Ivan Rilski /ID# 136210
Diagnostic Consultative Center /ID# 136736
Diagnostic consultative center Equita /ID# 136209
Corporacion de Beneficiencia Osorno /ID# 136189
Quantum Research /ID# 136188
Duplicate_Artroscan s.r.o. /ID# 139347
L.K.N. Arthrocentrum, s.r.o /ID# 128782
Revmatologicky ustav v Praze /ID# 137937
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776
Revmatologie Bruntal, s.r.o /ID# 137782
Qualiclinic Kft. /ID# 134170
Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785
Szent Margit Szakrendelo /ID# 136676
MAV Korhaz ess Rendelointezet /ID# 139971
Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784
The Chaim Sheba Medical Center /ID# 139295
Barzilai Medical Center /ID# 140199
M & M Centrs LTD /ID# 132439
Arija's Ancane's Family Doctor Practice /ID# 132437
Clinic ORTO /ID# 132438
Clinstile, S.A. de C.V. /ID# 137075
Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307
Cliditer SA de CV /ID# 136876
Timaru Medical Specialists Ltd /ID# 131909
Waikato Hospital /ID# 131908
Porter Rheumatology Ltd /ID# 133983
Reum-Medica S.C. /ID# 128841
Twoja Przychodnia Centrum Medyczne /ID# 128840
Pratia MCM Krakow /ID# 134749
NZOZ Lecznica MAK-MED s.c. /ID# 128838
Medicome sp. z o.o. /ID# 137397
Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835
Centrum Medyczne Pratia Warszawa /ID# 136650
Centrum Medyczne Reuma Park w Warszawie /ID# 140198
NBR Polska /ID# 136208
Gabinet Internistyczno-Reumatologiczny /ID# 135876
Centrum Medyczne Pratia Gdynia /ID# 137362
Ambulatorium Sp. z o.o /ID# 138074
Prywatna Praktyka Lekarska /ID# 128837
Duplicate_REUMED Filia nr 2 /ID# 128839
Dr. Ramon L. Ortega-Colon, MD /ID# 128760
GCM Medical Group PSC - Hato Rey /ID# 128759
Mindful Medical Research /ID# 136211
Kazan State Medical University /ID# 136734
Tver Regional Clinical Hospital /ID# 137576
St. Petersburg Research Institute of Emergency Medicine n.а. I. I. Dzhanelidze /ID# 136652
MEDMAN s.r.o. /ID# 136649
Poliklinika Senica n.o. /ID# 134728
Dr MJ Prins /ID# 138540
Winelands Medical Research Centre /ID# 134669
Clinica Gaias /ID# 133868
Hospital General Universitario de Elche /ID# 128851
Hospital Infanta Sofia /ID# 136653
Hospital Regional de Malaga /ID# 128847
Hospital Universitario A Coruna - CHUAC /ID# 128846
Hospital CIMA Sanitas /ID# 128849
Hospital Clinico Universitario San Carlos /ID# 128852
Hospital Universitario Virgen Macarena /ID# 128853
Hospital QuironSalud Infanta Luisa /ID# 135689
Hospital Universitario Virgen de Valme /ID# 134668
NSC Strazhesko Ist Cardiology /ID# 137330
Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334
Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514
Barts Health NHS Trust /ID# 135683
West Suffolk Hospital /ID# 128858
Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Upadacitinib

Arm Description

Participants 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).

Outcomes

Primary Outcome Measures

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: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).

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: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 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).

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: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 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).

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).

Secondary Outcome Measures

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2.

Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score < 2.6.

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time

The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10.

Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time

The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0.

Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time

Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time

The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time

Change From Baseline in Tender Joint Count (TJC68) Over Time

Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).

Change From Baseline in Swollen Joint Count (SJC66) Over Time

Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).

Change From Baseline in Physician's Global Assessment of Disease Activity Over Time

The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity

Change From Baseline in Patient's Global Assessment of Disease Activity Over Time

The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.

Change From Baseline in Patient's Assessment of Pain Over Time

Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time

Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time

The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.

Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time

RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score < 10 means low risk, scores between 10 and 17 indicate medium risk, and scores > 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability.

Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time

The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.

Change From Baseline in EuroQoL-5D VAS Score Over Time

The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement.

Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination

Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination

Full Information

NCT ID

NCT02049138

First Posted

January 28, 2014

Last Updated

June 15, 2022

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02049138

Brief Title

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

Acronym

BALANCE-EXTEND

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 24, 2014 (Actual)

Primary Completion Date

July 29, 2021 (Actual)

Study Completion Date

July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Rheumatoid Arthritis

Keywords

Musculoskeletal Disease, Arthritis, Joint Diseases, Anti-inflammatory Agents, Antirheumatic agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

493 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upadacitinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

ABT-494, RINVOQ®

Intervention Description

Tablet taken orally

Intervention Type

Biological

Intervention Name(s)

Pneumococcal 13-valent conjugate vaccine (PCV-13)

Other Intervention Name(s)

Prevnar 13®

Intervention Description

Administered by intramuscular injection

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

Description

Time Frame

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

Title

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

Description

Time Frame

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

Title

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

Description

Time Frame

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

Title

Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination

Description

Time Frame

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 Outcome Measure Information:

Title

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

Description

Time Frame

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

Title

Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time

Description

The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score < 2.6.

Time Frame

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

Title

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time

Description

Time Frame

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

Title

Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time

Description

Time Frame

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

Title

Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time

Description

Time Frame

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

Title

Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time

Description

Time Frame

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

Title

Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time

Description

Time Frame

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

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

Description

Time Frame

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

Title

Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time

Description

Time Frame

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

Title

Change From Baseline in Tender Joint Count (TJC68) Over Time

Description

Time Frame

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

Title

Change From Baseline in Swollen Joint Count (SJC66) Over Time

Description

Time Frame

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

Title

Change From Baseline in Physician's Global Assessment of Disease Activity Over Time

Description

Time Frame

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

Title

Change From Baseline in Patient's Global Assessment of Disease Activity Over Time

Description

Time Frame

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

Title

Change From Baseline in Patient's Assessment of Pain Over Time

Description

Time Frame

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

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time

Description

Time Frame

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

Title

Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time

Time Frame

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

Title

Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time

Description

Time Frame

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

Title

Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time

Description

Time Frame

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

Title

Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time

Description

Time Frame

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

Title

Change From Baseline in EuroQoL-5D VAS Score Over Time

Description

Time Frame

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

Title

Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination

Description

Time Frame

Vaccination Baseline and 12 weeks after vaccination

Title

Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination

Time Frame

Vaccination Baseline and 4 and 12 weeks after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Receiving > 10 mg/day of prednisone or equivalent corticosteroid therapy. Receipt of any steroid injection within 4 weeks prior to Vaccination visit. History of severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13®. History of any documented pneumococcal infection within the last 6 months prior to the vaccination visit. Receipt of any vaccine 4 weeks prior to the vaccination visit and/or anticipation of any vaccination for 4 weeks after the vaccination visit. Receipt of any pneumococcal vaccine. Subject is not suitable for the sub-study as per the Investigator's judgment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Rheum Assoc of North Alabama /ID# 135926

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

AZ Arthritis and Rheumotology Research, PLLC /ID# 135902

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032-9306

Country

United States

Facility Name

AZ Arthritis and Rheumotology Research, PLLC /ID# 135931

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032-9306

Country

United States

Facility Name

C.V. Mehta MD, Med Corporation /ID# 124092

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Moores Cancer Center at UC San Diego /ID# 128747

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Desert Medical Advances - Palm Desert /ID# 135911

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Orrin Troum, M.D. and Medical /ID# 135933

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Duplicate_Robin K. Dore MD, Inc /ID# 135906

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Inland Rheum Clin Trials Inc. /ID# 136716

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Duplicate_Desert Valley Medical Group /ID# 135932

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

Denver Arthritis Clinic /ID# 135901

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

New England Research Associates, LLC /ID# 124085

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606-1827

Country

United States

Facility Name

Arthritis & Rheumatic Disease Specialties /ID# 135910

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Omega Research Maitland, LLC /ID# 124094

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713-2260

Country

United States

Facility Name

University of Florida /ID# 124087

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Suncoast Research Group /ID# 137774

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Omega Research Maitland, LLC /ID# 137398

City

Orlando

State/Province

Florida

ZIP/Postal Code

32808

Country

United States

Facility Name

Millennium Research /ID# 135917

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Arthritis Center, Inc. /ID# 124090

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

IRIS Research and Development, LLC /ID# 140362

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Lovelace Scientific Resources /ID# 128745

City

Venice

State/Province

Florida

ZIP/Postal Code

34292

Country

United States

Facility Name

North Georgia Rheumatology Group /ID# 128746

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

Kansas City Internal Medicine /ID# 135916

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66209

Country

United States

Facility Name

PRN Professional Research Network of Kansas, LLC /ID# 124091

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Klein and Associates MD - Hagerstown /ID# 124086

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

The Center for Rheumatology and Bone Research /ID# 124077

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Clinical Pharmacology Study Group /ID# 124079

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

June DO, PC /ID# 124081

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Summit Medical Group /ID# 124076

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012-1647

Country

United States

Facility Name

Arthritis and Osteoporosis Associates /ID# 135907

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728-8307

Country

United States

Facility Name

Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Arthritis and Osteo Assoc /ID# 132280

City

Las Cruces

State/Province

New Mexico

ZIP/Postal Code

88011

Country

United States

Facility Name

DJL Clinical Research, PLLC /ID# 131936

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210-8508

Country

United States

Facility Name

Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242-4468

Country

United States

Facility Name

STAT Research, Inc. /ID# 134906

City

Vandalia

State/Province

Ohio

ZIP/Postal Code

45377-9464

Country

United States

Facility Name

Health Research of Oklahoma /ID# 135904

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103-2400

Country

United States

Facility Name

Duplicate_East Penn Rheumatology Assoc /ID# 135920

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Altoona Ctr Clinical Res /ID# 124089

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Emkey Arthritis and Osteoporosis Clinic /ID# 135908

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486-7887

Country

United States

Facility Name

Dr. Ramesh Gupta /ID# 128744

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Austin Rheumatology Research /ID# 124083

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Accurate Clinical Management /ID# 128751

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

Accurate Clinical Management /ID# 128752

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Baylor College of Medicine - Baylor Medical Center /ID# 135905

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-3411

Country

United States

Facility Name

Houston Institute for Clin Res /ID# 135912

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Accurate Clinical Research /ID# 128753

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Accurate Clinical Research /ID# 128754

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

SW Rheumatology Res. LLC /ID# 135927

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Mountain State Clinical Research /ID# 124088

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Aurora Rheumatology and Immunotherapy Center /ID# 135922

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

UCL Saint-Luc /ID# 139348

City

Woluwe-Saint-Lambert

State/Province

Bruxelles-Capitale

ZIP/Postal Code

1200

Country

Belgium

Facility Name

ReumaClinic Genk-Hasselt /ID# 137775

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

MHAT Trimontsium /ID# 135328

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Duplicate_MHAT Kaspela /ID# 136212

City

Plovdiv

ZIP/Postal Code

4001

Country

Bulgaria

Facility Name

UHMAT Palmed Plovdiv /ID# 135355

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

UMHAT Sveti Ivan Rilski /ID# 135678

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

UMHAT Sveti Ivan Rilski /ID# 136210

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Diagnostic Consultative Center /ID# 136736

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Diagnostic consultative center Equita /ID# 136209

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Corporacion de Beneficiencia Osorno /ID# 136189

City

Osorno

State/Province

Los Lagos

ZIP/Postal Code

1710216

Country

Chile

Facility Name

Quantum Research /ID# 136188

City

Puerto Varas

State/Province

Los Lagos

ZIP/Postal Code

5550170

Country

Chile

Facility Name

Duplicate_Artroscan s.r.o. /ID# 139347

City

Ostrava

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

L.K.N. Arthrocentrum, s.r.o /ID# 128782

City

Petrkovice

ZIP/Postal Code

725 29

Country

Czechia

Facility Name

Revmatologicky ustav v Praze /ID# 137937

City

Praha

ZIP/Postal Code

128 00

Country

Czechia

Facility Name

Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776

City

Praha

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Revmatologie Bruntal, s.r.o /ID# 137782

City

Prostejov

ZIP/Postal Code

796 01

Country

Czechia

Facility Name

Qualiclinic Kft. /ID# 134170

City

Budapest

State/Province

Pest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Szent Margit Szakrendelo /ID# 136676

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

MAV Korhaz ess Rendelointezet /ID# 139971

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

The Chaim Sheba Medical Center /ID# 139295

City

Ramat Gan

State/Province

Tel-Aviv

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Barzilai Medical Center /ID# 140199

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

M & M Centrs LTD /ID# 132439

City

Adazi

ZIP/Postal Code

LV-2164

Country

Latvia

Facility Name

Arija's Ancane's Family Doctor Practice /ID# 132437

City

Baldone

ZIP/Postal Code

LV-2125

Country

Latvia

Facility Name

Clinic ORTO /ID# 132438

City

Riga

ZIP/Postal Code

LV-1005

Country

Latvia

Facility Name

Clinstile, S.A. de C.V. /ID# 137075

City

Cuauhtemoc

State/Province

Ciudad De Mexico

ZIP/Postal Code

20313

Country

Mexico

Facility Name

Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307

City

Mexico City

ZIP/Postal Code

06090

Country

Mexico

Facility Name

Cliditer SA de CV /ID# 136876

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Timaru Medical Specialists Ltd /ID# 131909

City

Timaru

State/Province

Canterbury

ZIP/Postal Code

7910

Country

New Zealand

Facility Name

Waikato Hospital /ID# 131908

City

Hamilton

State/Province

Waikato

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Porter Rheumatology Ltd /ID# 133983

City

Nelson

ZIP/Postal Code

7010

Country

New Zealand

Facility Name

Reum-Medica S.C. /ID# 128841

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-244

Country

Poland

Facility Name

Twoja Przychodnia Centrum Medyczne /ID# 128840

City

Nowa Sol

State/Province

Lubuskie

ZIP/Postal Code

67-100

Country

Poland

Facility Name

Pratia MCM Krakow /ID# 134749

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

30-510

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED s.c. /ID# 128838

City

Nadarzyn

State/Province

Mazowieckie

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Medicome sp. z o.o. /ID# 137397

City

Oswiecim

State/Province

Mazowieckie

ZIP/Postal Code

32-600

Country

Poland

Facility Name

Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

01-518

Country

Poland

Facility Name

Centrum Medyczne Pratia Warszawa /ID# 136650

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Centrum Medyczne Reuma Park w Warszawie /ID# 140198

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

02-691

Country

Poland

Facility Name

NBR Polska /ID# 136208

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

00-465

Country

Poland

Facility Name

Gabinet Internistyczno-Reumatologiczny /ID# 135876

City

Bialystok

State/Province

Podlaskie

ZIP/Postal Code

15-077

Country

Poland

Facility Name

Centrum Medyczne Pratia Gdynia /ID# 137362

City

Gdynia

State/Province

Pomorskie

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Ambulatorium Sp. z o.o /ID# 138074

City

Elblag

State/Province

Warminsko-mazurskie

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Prywatna Praktyka Lekarska /ID# 128837

City

Poznan

State/Province

Wielkopolskie

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Duplicate_REUMED Filia nr 2 /ID# 128839

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Dr. Ramon L. Ortega-Colon, MD /ID# 128760

City

Carolina

ZIP/Postal Code

00983

Country

Puerto Rico

Facility Name

GCM Medical Group PSC - Hato Rey /ID# 128759

City

San Juan

ZIP/Postal Code

00917-3104

Country

Puerto Rico

Facility Name

Mindful Medical Research /ID# 136211

City

San Juan

ZIP/Postal Code

00918-3756

Country

Puerto Rico

Facility Name

Kazan State Medical University /ID# 136734

City

Kazan

State/Province

Tatarstan, Respublika

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Tver Regional Clinical Hospital /ID# 137576

City

Tver

State/Province

Tverskaya Oblast

ZIP/Postal Code

170036

Country

Russian Federation

Facility Name

St. Petersburg Research Institute of Emergency Medicine n.а. I. I. Dzhanelidze /ID# 136652

City

Sankt-Peterburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

MEDMAN s.r.o. /ID# 136649

City

Martin

ZIP/Postal Code

036 01

Country

Slovakia

Facility Name

Poliklinika Senica n.o. /ID# 134728

City

Senica

ZIP/Postal Code

905 01

Country

Slovakia

Facility Name

Dr MJ Prins /ID# 138540

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Winelands Medical Research Centre /ID# 134669

City

Stellenbosch

State/Province

Western Cape

ZIP/Postal Code

7600

Country

South Africa

Facility Name

Clinica Gaias /ID# 133868

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15702

Country

Spain

Facility Name

Hospital General Universitario de Elche /ID# 128851

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Hospital Infanta Sofia /ID# 136653

City

San Sebastián de Los Reyes

State/Province

Madrid

ZIP/Postal Code

28702

Country

Spain

Facility Name

Hospital Regional de Malaga /ID# 128847

City

Málaga

State/Province

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Universitario A Coruna - CHUAC /ID# 128846

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital CIMA Sanitas /ID# 128849

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Hospital Clinico Universitario San Carlos /ID# 128852

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena /ID# 128853

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital QuironSalud Infanta Luisa /ID# 135689

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Hospital Universitario Virgen de Valme /ID# 134668

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

NSC Strazhesko Ist Cardiology /ID# 137330

City

Kiev

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514

City

Warrington

State/Province

Cheshire West And Chester

ZIP/Postal Code

WA5 1QG

Country

United Kingdom

Facility Name

Barts Health NHS Trust /ID# 135683

City

London

State/Province

London, City Of

ZIP/Postal Code

E1 2ES

Country

United Kingdom

Facility Name

West Suffolk Hospital /ID# 128858

City

Bury St Edmunds

State/Province

Suffolk

ZIP/Postal Code

IP33 2QZ

Country

United Kingdom

Facility Name

Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

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

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Citations:

PubMed Identifier

35246470

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.

Results Reference

derived

Links:

URL

https://www.rxabbvie.com/

Description

Related Info.

Learn more about this trial

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

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