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

NCT ID: NCT04267536

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 534 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2022-02-01

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.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants treated with upadacitinib monotherapy

Participants will receive upadacitinib for 12 months as prescribed by the physician

No interventions assigned to this group

Participants treated with upadacitinib in combination with MTX

Participants will receive upadacitinib in combination with MTX as prescribed by the physician for 12 months

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Praxis Dr. Rinaldi /ID# 218424

Ulm, Baden-Wurttemberg, Germany

Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428

Munich, Bavaria, Germany

Rheumahaus Studien GbR, Potsdam, DE /ID# 218430

Potsdam, Brandenburg, Germany

Rheumazentrum Ruhrgebiet /ID# 221388

Herne, North Rhine-Westphalia, Germany

Praxis Dr. Lüthke /ID# 218900

Dresden, Saxony, Germany

Kupka & Kupka, Altenburg, DE /ID# 218413

Altenburg, , Germany

Marycz, Amberg, DE /ID# 220808

Amberg, , Germany

Rheumapraxis am Webereck /ID# 218712

Augsburg, , Germany

MVZ Weserbergland /ID# 220809

Bad Pyrmont, , Germany

Internistische-rheumatologische Praxisgemeinschaft /ID# 218540

Bayreuth, , Germany

Bozorg-Doagoo, Berlin, DE /ID# 218431

Berlin, , Germany

Praxis Dr. Silke Zinke /ID# 218433

Berlin, , Germany

Eisterhues, Braunschweig, DE /ID# 218532

Braunschweig, , Germany

Medizinische Versorgungszentren Burghausen Altoetting /ID# 221385

Burghausen, , Germany

Med Versorgungszentrum AGILOMED /ID# 218538

Chemnitz, , Germany

Dres. Schuh /ID# 218541

Coburg, , Germany

Rheumatologisches MVZ Dresden /ID# 218411

Dresden, , Germany

Rheumapraxis Düren /ID# 224950

Düren, , Germany

Strothmeyer & Scheulen /ID# 218426

Düsseldorf, , Germany

Praxis Dilltal /ID# 218427

Ehringshausen, , Germany

Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 222579

Erlangen, , Germany

Dres. Waehrisch/Flaxenberg /ID# 218711

Essen, , Germany

Michael Mueller, Freiberg, DE /ID# 218414

Freiberg, , Germany

Praxis Dr. Kuehne /ID# 221389

Haldensleben I, , Germany

Praxis Dr. Liebhaber /ID# 218899

Halle, , Germany

Aries, Hamburg, DE /ID# 220804

Hamburg, , Germany

Stille, Hanover, DE /ID# 218429

Hanover, , Germany

Medizinische Hochschule Hannover /ID# 222068

Hanover, , Germany

Heilig, Heidelberg, DE /ID# 221391

Heidelberg, , Germany

Praxis K. Pagel /ID# 218714

Hoppegarten, , Germany

Hamann & Teich & Boche,Leipzig /ID# 218531

Leipzig, , Germany

Schwarze/Haeder, Leipzig, DE /ID# 218412

Leipzig, , Germany

Dres. Teipel/Toussaint/Saech /ID# 223969

Leverkusen, , Germany

Aurich & Sieburg, Magdeburg /ID# 220811

Magdeburg, , Germany

Harmuth, Marktredwitz, DE /ID# 218715

Marktredwitz, , Germany

Prof-med-stud.de /ID# 218534

Munich, , Germany

Praxis Dr. med Thilo Klopsch /ID# 218535

Neubrandenburg, , Germany

Praxis Hein & Gess /ID# 218716

Nienburg, , Germany

Praxis Hein & Gess /ID# 218896

Nienburg, , Germany

Elisabeth-Klinik Bigge /ID# 218425

Olsberg, , Germany

MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 218543

Planegg, , Germany

Knappschaftsklinikum Saar /ID# 218901

Püttlingen, , Germany

Rheumazentrum Ratingen /ID# 218897

Ratingen, , Germany

Rheumatologische Gemeinschaftspraxis Schwerin /ID# 218432

Schwerin, , Germany

Melzer, Seesen, DE /ID# 220803

Seesen, , Germany

Rheumatologische Schwerpunktpraxis /ID# 218415

Stuttgart, , Germany

Bruederkrankenhaus Trier /ID# 221393

Trier, , Germany

Praxis Dr. Haas /ID# 218423

Tübingen, , Germany

Rheumathologie Ulm /ID# 218539

Ulm, , Germany

Krankenhaus St. Josef /ID# 221392

Wuppertal, , Germany

Praxis Barmen /ID# 218895

Wuppertal, , Germany

Fricke-Wagner, Zwickau, DE /ID# 218533

Zwickau, , Germany

Countries

Germany

Related Links

https://www.abbvieclinicaltrials.com/study/?id=P20-078&Latitude=&Longitude=&LocationName=#additional-resources-section

clinical study report synopsis

Other Identifiers

P20-078

Identifier Type: -

Identifier Source: org_study_id