An Observational Study to Evaluate Impact of CRP-Level on Real World Effectiveness of Upadacitinib as Monotherapy or in Combination With MTX in Adult Participants With Rheumatoid Arthritis
UPWARDS
UPwArds - Post Marketing Observational Study to Evaluate the Impact of CRP-Level on the Real World Effectiveness of UPadacitinib When Used in MonotherApy or in Combination With MTX in Patients With RheumatoiD ArthritiS
1 other identifier
observational
534
1 country
52
Brief Summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA. CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany. Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months. No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2020
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJanuary 26, 2023
January 1, 2023
2 years
February 11, 2020
January 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Remission
Remission is defined as clinical disease activity index (CDAI) \<=2.8
6 Months
Secondary Outcomes (26)
Percentage of Participants Achieving Remission
Up to 12 Months
Percentage of Participants Achieving Low Disease Activity (LDA)
Up to 12 Months
Mean Change From Baseline in CDAI
Up to 12 Months
Mean Change From Baseline in SDAI
Up to 12 Months
Mean Change From Baseline in DAS28-CRP
Up to 12 Months
- +21 more secondary outcomes
Study Arms (2)
Participants treated with upadacitinib monotherapy
Participants will receive upadacitinib for 12 months as prescribed by the physician
Participants treated with upadacitinib in combination with MTX
Participants will receive upadacitinib in combination with MTX as prescribed by the physician for 12 months
Eligibility Criteria
Adult Participants with moderate to severe rheumatoid arthritis (RA)
You may qualify if:
- Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
- Swollen Joint Count (SJC) \>= 3 of 28 joints of the Disease Activity Score (DAS)28.
- Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or \<= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was \<= 10 mg/day for at least 7 days.
- Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC).
- Decision on the treatment with Upadacitinib was made prior to any decision to approach the patient to participate in this study.
You may not qualify if:
- Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC.
- Prior treatment with Upadacitinib.
- Participants currently participating in interventional research.
- Participants who are unwilling or unable to complete the patient reported questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (52)
Praxis Dr. Rinaldi /ID# 218424
Ulm, Baden-Wurttemberg, 89073, Germany
Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428
Munich, Bavaria, 81541, Germany
Rheumahaus Studien GbR, Potsdam, DE /ID# 218430
Potsdam, Brandenburg, 14467, Germany
Rheumazentrum Ruhrgebiet /ID# 221388
Herne, North Rhine-Westphalia, 44649, Germany
Praxis Dr. Lüthke /ID# 218900
Dresden, Saxony, 01097, Germany
Kupka & Kupka, Altenburg, DE /ID# 218413
Altenburg, 04600, Germany
Marycz, Amberg, DE /ID# 220808
Amberg, 92224, Germany
Rheumapraxis am Webereck /ID# 218712
Augsburg, 86157, Germany
MVZ Weserbergland /ID# 220809
Bad Pyrmont, 31812, Germany
Internistische-rheumatologische Praxisgemeinschaft /ID# 218540
Bayreuth, 95444, Germany
Bozorg-Doagoo, Berlin, DE /ID# 218431
Berlin, 10713, Germany
Praxis Dr. Silke Zinke /ID# 218433
Berlin, 13055, Germany
Eisterhues, Braunschweig, DE /ID# 218532
Braunschweig, 38100, Germany
Medizinische Versorgungszentren Burghausen Altoetting /ID# 221385
Burghausen, 84489, Germany
Med Versorgungszentrum AGILOMED /ID# 218538
Chemnitz, 09130, Germany
Dres. Schuh /ID# 218541
Coburg, 96450, Germany
Rheumatologisches MVZ Dresden /ID# 218411
Dresden, 01109, Germany
Rheumapraxis Düren /ID# 224950
Düren, 52355, Germany
Strothmeyer & Scheulen /ID# 218426
Düsseldorf, 40211, Germany
Praxis Dilltal /ID# 218427
Ehringshausen, 35630, Germany
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 222579
Erlangen, 91056, Germany
Dres. Waehrisch/Flaxenberg /ID# 218711
Essen, 45326, Germany
Michael Mueller, Freiberg, DE /ID# 218414
Freiberg, 09599, Germany
Praxis Dr. Kuehne /ID# 221389
Haldensleben I, 39340, Germany
Praxis Dr. Liebhaber /ID# 218899
Halle, 06128, Germany
Aries, Hamburg, DE /ID# 220804
Hamburg, 22767, Germany
Stille, Hanover, DE /ID# 218429
Hanover, 30161, Germany
Medizinische Hochschule Hannover /ID# 222068
Hanover, 30625, Germany
Heilig, Heidelberg, DE /ID# 221391
Heidelberg, 69120, Germany
Praxis K. Pagel /ID# 218714
Hoppegarten, 15366, Germany
Hamann & Teich & Boche,Leipzig /ID# 218531
Leipzig, 04109, Germany
Schwarze/Haeder, Leipzig, DE /ID# 218412
Leipzig, 04129, Germany
Dres. Teipel/Toussaint/Saech /ID# 223969
Leverkusen, 51373, Germany
Aurich & Sieburg, Magdeburg /ID# 220811
Magdeburg, 39104, Germany
Harmuth, Marktredwitz, DE /ID# 218715
Marktredwitz, 95615, Germany
Prof-med-stud.de /ID# 218534
Munich, 80935, Germany
Praxis Dr. med Thilo Klopsch /ID# 218535
Neubrandenburg, 17033, Germany
Praxis Hein & Gess /ID# 218716
Nienburg, 31582, Germany
Praxis Hein & Gess /ID# 218896
Nienburg, 31582, Germany
Elisabeth-Klinik Bigge /ID# 218425
Olsberg, 59939, Germany
MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 218543
Planegg, 82152, Germany
Knappschaftsklinikum Saar /ID# 218901
Püttlingen, 66346, Germany
Rheumazentrum Ratingen /ID# 218897
Ratingen, 40882, Germany
Rheumatologische Gemeinschaftspraxis Schwerin /ID# 218432
Schwerin, 19053, Germany
Melzer, Seesen, DE /ID# 220803
Seesen, 38723, Germany
Rheumatologische Schwerpunktpraxis /ID# 218415
Stuttgart, 70372, Germany
Bruederkrankenhaus Trier /ID# 221393
Trier, 54292, Germany
Praxis Dr. Haas /ID# 218423
Tübingen, 72072, Germany
Rheumathologie Ulm /ID# 218539
Ulm, 89073, Germany
Krankenhaus St. Josef /ID# 221392
Wuppertal, 42105, Germany
Praxis Barmen /ID# 218895
Wuppertal, 42285, Germany
Fricke-Wagner, Zwickau, DE /ID# 218533
Zwickau, 08060, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
February 6, 2020
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
January 26, 2023
Record last verified: 2023-01