Clinical trial NCT04267536: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis (RA)
Upadacitinib
RINVOQ
Methotrexate (MTX)
ABT-494
C-reactive protein (CRP)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Participants with moderate to severe rheumatoid arthritis (RA)

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC.
* Prior treatment with Upadacitinib.
* Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured.
* Participants currently participating in interventional research.
* Participants who are unwilling or unable to complete the patient reported questionnaires.

Primary outcomes:
measure: Percentage of Participants Achieving Remission
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants Achieving Remission
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Low Disease Activity (LDA)
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in CDAI
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in SDAI
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in DAS28-CRP
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in DAS28-ESR
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in Pain
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)
timeFrame: Up to 12 Months
measure: Mean Change From Baseline in Fatigue
timeFrame: Up to 12 Months
measure: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving RAID <= 3
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving RAID > 3 and <=4
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving RAID > 4 and <=6
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving RAID > 6
timeFrame: Up to 12 Months
measure: Change From Baseline in Morning Stiffness Severity
timeFrame: Up to 12 Months
measure: Change From Baseline in Morning Stiffness Duration
timeFrame: Up to 12 Months
measure: Change From Baseline in Functionality (FFbH)
timeFrame: Up to 12 Months
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 12 Months
measure: Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9
timeFrame: Up to 12 Months
measure: Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX
timeFrame: Up to 12 Months
measure: Percentage of Participants With LDA or Remission With Actual Concomitant MTX
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Praxis Dr. Rinaldi /ID# 218424
state: Baden-Wuerttemberg
city: Munich
country: Germany
facility: Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428
state: Bayern
city: Potsdam
country: Germany
facility: Rheumahaus Studien GbR, Potsdam, DE /ID# 218430
state: Brandenburg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 221388
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Praxis Dr. Lüthke /ID# 218900
state: Sachsen
city: Altenburg
country: Germany
facility: Kupka & Kupka, Altenburg, DE /ID# 218413
city: Amberg
country: Germany
facility: Marycz, Amberg, DE /ID# 220808
city: Augsburg
country: Germany
facility: Rheumapraxis am Webereck /ID# 218712
city: Bad Pyrmont
country: Germany
facility: MVZ Weserbergland /ID# 220809
city: Bayreuth
country: Germany
facility: Internistische-rheumatologische Praxisgemeinschaft /ID# 218540
city: Berlin
country: Germany
facility: Bozorg-Doagoo, Berlin, DE /ID# 218431
city: Berlin
country: Germany
facility: Praxis Dr. Silke Zinke /ID# 218433
city: Braunschweig
country: Germany
facility: Eisterhues, Braunschweig, DE /ID# 218532
city: Burghausen
country: Germany
facility: Medizinische Versorgungszentren Burghausen Altoetting /ID# 221385
city: Chemnitz
country: Germany
facility: Med Versorgungszentrum AGILOMED /ID# 218538
city: Coburg
country: Germany
facility: Dres. Schuh /ID# 218541
city: Dresden
country: Germany
facility: Rheumatologisches MVZ Dresden /ID# 218411
city: Duesseldorf
country: Germany
facility: Strothmeyer & Scheulen /ID# 218426
city: Düren
country: Germany
facility: Rheumapraxis Düren /ID# 224950
city: Ehringshausen
country: Germany
facility: Praxis Dilltal /ID# 218427
city: Erlangen
country: Germany
facility: Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 222579
city: Essen
country: Germany
facility: Dres. Waehrisch/Flaxenberg /ID# 218711
city: Freiberg
country: Germany
facility: Michael Mueller, Freiberg, DE /ID# 218414
city: Haldensleben
country: Germany
facility: Praxis Dr. Kuehne /ID# 221389
city: Halle
country: Germany
facility: Praxis Dr. Liebhaber /ID# 218899
city: Hamburg
country: Germany
facility: Aries, Hamburg, DE /ID# 220804
city: Hannover
country: Germany
facility: Stille, Hanover, DE /ID# 218429
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 222068
city: Heidelberg
country: Germany
facility: Heilig, Heidelberg, DE /ID# 221391
city: Hoppegarten
country: Germany
facility: Praxis K. Pagel /ID# 218714
city: Leipzig
country: Germany
facility: Hamann & Teich & Boche,Leipzig /ID# 218531
city: Leipzig
country: Germany
facility: Schwarze/Haeder, Leipzig, DE /ID# 218412
city: Leverkusen
country: Germany
facility: Dres. Teipel/Toussaint/Saech /ID# 223969
city: Magdeburg
country: Germany
facility: Aurich & Sieburg, Magdeburg /ID# 220811
city: Marktredwitz
country: Germany
facility: Harmuth, Marktredwitz, DE /ID# 218715
city: Munich
country: Germany
facility: Prof-med-stud.de /ID# 218534
city: Neubrandenburg
country: Germany
facility: Praxis Dr. med Thilo Klopsch /ID# 218535
city: Nienburg
country: Germany
facility: Praxis Hein & Gess /ID# 218716
city: Nienburg
country: Germany
facility: Praxis Hein & Gess /ID# 218896
city: Olsberg
country: Germany
facility: Elisabeth-Klinik Bigge /ID# 218425
city: Planegg
country: Germany
facility: MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 218543
city: Puettlingen
country: Germany
facility: Knappschaftsklinikum Saar /ID# 218901
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen /ID# 218897
city: Schwerin
country: Germany
facility: Rheumatologische Gemeinschaftspraxis Schwerin /ID# 218432
city: Seesen
country: Germany
facility: Melzer, Seesen, DE /ID# 220803
city: Stuttgart
country: Germany
facility: Rheumatologische Schwerpunktpraxis /ID# 218415
city: Trier
country: Germany
facility: Bruederkrankenhaus Trier /ID# 221393
city: Tuebingen
country: Germany
facility: Praxis Dr. Haas /ID# 218423
city: Ulm
country: Germany
facility: Rheumathologie Ulm /ID# 218539
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef /ID# 221392
city: Wuppertal
country: Germany
facility: Praxis Barmen /ID# 218895
city: Zwickau
country: Germany
facility: Fricke-Wagner, Zwickau, DE /ID# 218533
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: