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

Rheumatoid Arthritis (RA) Clinical Trial

— UPWARDS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267536
• Other study ID #: P20-078
• Status: Completed
• Start date: February 6, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Locations

Country	Name	City	State
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	Praxis Dr. Lüthke /ID# 218900	Dresden	Sachsen
Germany	Rheumatologisches MVZ Dresden /ID# 218411	Dresden
Germany	Strothmeyer & Scheulen /ID# 218426	Duesseldorf
Germany	Rheumapraxis Düren /ID# 224950	Düren
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
Germany	Praxis Dr. Liebhaber /ID# 218899	Halle
Germany	Aries, Hamburg, DE /ID# 220804	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 222068	Hannover
Germany	Stille, Hanover, DE /ID# 218429	Hannover
Germany	Heilig, Heidelberg, DE /ID# 221391	Heidelberg
Germany	Rheumazentrum Ruhrgebiet /ID# 221388	Herne	Nordrhein-Westfalen
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	Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428	Munich	Bayern
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	Rheumahaus Studien GbR, Potsdam, DE /ID# 218430	Potsdam	Brandenburg
Germany	Knappschaftsklinikum Saar /ID# 218901	Puettlingen
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	Tuebingen
Germany	Praxis Dr. Rinaldi /ID# 218424	Ulm	Baden-Wuerttemberg
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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Remission	Remission is defined as clinical disease activity index (CDAI) <=2.8	6 Months
Secondary	Percentage of Participants Achieving Remission	Remission is defined as the disease activity score at 28 joints (DAS28)-C-Reactive protein (CRP)<2.6, DAS28- erythrocyte sedimentation rate (ESR)<2.6, simplified disease activity index (SDAI)<=3.3, CDAI<=2.8, Boolean.	Up to 12 Months
Secondary	Percentage of Participants Achieving Low Disease Activity (LDA)	LDA is defined as DAS28-CRP<3.2, DAS28-ESR<3.2, SDAI <=11, CDAI<=10	Up to 12 Months
Secondary	Mean Change From Baseline in CDAI	The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale (VAS) from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity).	Up to 12 Months
Secondary	Mean Change From Baseline in SDAI	The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 (lowest disease activity) to 86 (highest disease activity).	Up to 12 Months
Secondary	Mean Change From Baseline in DAS28-CRP	The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).	Up to 12 Months
Secondary	Mean Change From Baseline in DAS28-ESR	The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).	Up to 12 Months
Secondary	Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)	Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)	Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)	Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Mean Change From Baseline in Pain	The NRS of Pain sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)	Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)	Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)	Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Mean Change From Baseline in Fatigue	Change in Fatigue is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.	Up to 12 Months
Secondary	Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)	RAID is a tool for assessment of disease activity purely based on a patient questionnaire.	Up to 12 Months
Secondary	Percentage of Participants Achieving RAID <= 3	RAID is a tool for assessment of disease activity purely based on a patient questionnaire.	Up to 12 Months
Secondary	Percentage of Participants Achieving RAID > 3 and <=4	RAID is a tool for assessment of disease activity purely based on a patient questionnaire.	Up to 12 Months
Secondary	Percentage of Participants Achieving RAID > 4 and <=6	RAID is a tool for assessment of disease activity purely based on a patient questionnaire.	Up to 12 Months
Secondary	Percentage of Participants Achieving RAID > 6	RAID is a tool for assessment of disease activity purely based on a patient questionnaire.	Up to 12 Months
Secondary	Change From Baseline in Morning Stiffness Severity	Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe".	Up to 12 Months
Secondary	Change From Baseline in Morning Stiffness Duration	The duration of morning stiffness was reported by participants as the average daily length during the past week in minutes (from time of awaking to time of maximal improvement).	Up to 12 Months
Secondary	Change From Baseline in Functionality (FFbH)	A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score.	Up to 12 Months
Secondary	Change From Baseline in Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression.	Up to 12 Months
Secondary	Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9	MCID is defined as the at least 5 points difference from baseline in PHQ-9. The PHQ-9 is a 9-item questionnaire for assessing the severity of depression.	Up to 12 Months
Secondary	Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX	LDA is defined as DAS28 < 3.2, CDAI<=10, SDAI <11. Remission is defined as DAS28<2.6, CDAI<=2.8; Boolean Remission.	Up to 12 Months
Secondary	Percentage of Participants With LDA or Remission With Actual Concomitant MTX	LDA is defined as DAS28 < 3.2, CDAI<=10, SDAI <11. Remission is defined as DAS28<2.6, CDAI<=2.8; Boolean Remission.	Up to 12 Months

External Links

•   clinical study report synopsis