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
- Conditions
- Rheumatoid Arthritis (RA)
- Registration Number
- NCT04267536
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Remission 6 Months Remission is defined as clinical disease activity index (CDAI) \<=2.8
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in DAS28-ESR Up to 12 Months 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).
Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %) Up to 12 Months 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.
Mean Change From Baseline in Fatigue Up to 12 Months 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.
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Up to 12 Months RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Percentage of Participants Achieving RAID <= 3 Up to 12 Months RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Change From Baseline in Patient Health Questionnaire (PHQ-9) Up to 12 Months 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.
Mean Change From Baseline in DAS28-CRP Up to 12 Months 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).
Percentage of Participants Achieving Pain Reduction (Improvement by 70 %) Up to 12 Months 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.
Change From Baseline in Morning Stiffness Severity Up to 12 Months 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".
Mean Change From Baseline in CDAI Up to 12 Months 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).
Percentage of Participants Achieving Pain Reduction (Improvement by 50 %) Up to 12 Months 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.
Percentage of Participants Achieving Remission Up to 12 Months 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.
Mean Change From Baseline in Pain Up to 12 Months The NRS of Pain sheet will be filled out in the office by participants at the designated visits.
Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %) Up to 12 Months 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.
Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX Up to 12 Months LDA is defined as DAS28 \< 3.2, CDAI\<=10, SDAI \<11. Remission is defined as DAS28\<2.6, CDAI\<=2.8; Boolean Remission.
Percentage of Participants Achieving Low Disease Activity (LDA) Up to 12 Months LDA is defined as DAS28-CRP\<3.2, DAS28-ESR\<3.2, SDAI \<=11, CDAI\<=10
Mean Change From Baseline in SDAI Up to 12 Months 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).
Percentage of Participants Achieving Pain Reduction (Improvement by 30 %) Up to 12 Months 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.
Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %) Up to 12 Months 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.
Percentage of Participants Achieving RAID > 3 and <=4 Up to 12 Months RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Percentage of Participants Achieving RAID > 4 and <=6 Up to 12 Months RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Percentage of Participants Achieving RAID > 6 Up to 12 Months RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Change From Baseline in Morning Stiffness Duration Up to 12 Months 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).
Percentage of Participants With LDA or Remission With Actual Concomitant MTX Up to 12 Months LDA is defined as DAS28 \< 3.2, CDAI\<=10, SDAI \<11. Remission is defined as DAS28\<2.6, CDAI\<=2.8; Boolean Remission.
Change From Baseline in Functionality (FFbH) Up to 12 Months 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.
Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9 Up to 12 Months 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.
Trial Locations
- Locations (52)
Rheumahaus Studien GbR, Potsdam, DE /ID# 218430
🇩🇪Potsdam, Brandenburg, Germany
Stille, Hanover, DE /ID# 218429
🇩🇪Hannover, Germany
Praxis K. Pagel /ID# 218714
🇩🇪Hoppegarten, Germany
Harmuth, Marktredwitz, DE /ID# 218715
🇩🇪Marktredwitz, Germany
Praxis Hein & Gess /ID# 218716
🇩🇪Nienburg, Germany
Prof-med-stud.de /ID# 218534
🇩🇪Munich, Germany
Praxis Dr. med Thilo Klopsch /ID# 218535
🇩🇪Neubrandenburg, Germany
MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 218543
🇩🇪Planegg, Germany
Rheumatologische Gemeinschaftspraxis Schwerin /ID# 218432
🇩🇪Schwerin, Germany
Melzer, Seesen, DE /ID# 220803
🇩🇪Seesen, Germany
Rheumazentrum Ruhrgebiet /ID# 221388
🇩🇪Herne, Nordrhein-Westfalen, Germany
Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428
🇩🇪Munich, Bayern, Germany
Praxis Dr. Rinaldi /ID# 218424
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Praxis Dr. Lüthke /ID# 218900
🇩🇪Dresden, Sachsen, Germany
Rheumapraxis am Webereck /ID# 218712
🇩🇪Augsburg, Germany
MVZ Weserbergland /ID# 220809
🇩🇪Bad Pyrmont, Germany
Marycz, Amberg, DE /ID# 220808
🇩🇪Amberg, Germany
Kupka & Kupka, Altenburg, DE /ID# 218413
🇩🇪Altenburg, Germany
Praxis Dr. Silke Zinke /ID# 218433
🇩🇪Berlin, Germany
Internistische-rheumatologische Praxisgemeinschaft /ID# 218540
🇩🇪Bayreuth, Germany
Eisterhues, Braunschweig, DE /ID# 218532
🇩🇪Braunschweig, Germany
Bozorg-Doagoo, Berlin, DE /ID# 218431
🇩🇪Berlin, Germany
Med Versorgungszentrum AGILOMED /ID# 218538
🇩🇪Chemnitz, Germany
Medizinische Versorgungszentren Burghausen Altoetting /ID# 221385
🇩🇪Burghausen, Germany
Strothmeyer & Scheulen /ID# 218426
🇩🇪Duesseldorf, Germany
Dres. Schuh /ID# 218541
🇩🇪Coburg, Germany
Rheumatologisches MVZ Dresden /ID# 218411
🇩🇪Dresden, Germany
Heilig, Heidelberg, DE /ID# 221391
🇩🇪Heidelberg, Germany
Rheumapraxis Düren /ID# 224950
🇩🇪Düren, Germany
Praxis Dilltal /ID# 218427
🇩🇪Ehringshausen, Germany
Dres. Waehrisch/Flaxenberg /ID# 218711
🇩🇪Essen, Germany
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 222579
🇩🇪Erlangen, Germany
Praxis Dr. Kuehne /ID# 221389
🇩🇪Haldensleben, Germany
Michael Mueller, Freiberg, DE /ID# 218414
🇩🇪Freiberg, Germany
Aries, Hamburg, DE /ID# 220804
🇩🇪Hamburg, Germany
Praxis Dr. Liebhaber /ID# 218899
🇩🇪Halle, Germany
Medizinische Hochschule Hannover /ID# 222068
🇩🇪Hannover, 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
Praxis Hein & Gess /ID# 218896
🇩🇪Nienburg, Germany
Elisabeth-Klinik Bigge /ID# 218425
🇩🇪Olsberg, Germany
Rheumazentrum Ratingen /ID# 218897
🇩🇪Ratingen, Germany
Knappschaftsklinikum Saar /ID# 218901
🇩🇪Puettlingen, Germany
Praxis Dr. Haas /ID# 218423
🇩🇪Tuebingen, Germany
Rheumatologische Schwerpunktpraxis /ID# 218415
🇩🇪Stuttgart, Germany
Bruederkrankenhaus Trier /ID# 221393
🇩🇪Trier, Germany
Rheumathologie Ulm /ID# 218539
🇩🇪Ulm, Germany
Krankenhaus St. Josef /ID# 221392
🇩🇪Wuppertal, Germany
Fricke-Wagner, Zwickau, DE /ID# 218533
🇩🇪Zwickau, Germany
Praxis Barmen /ID# 218895
🇩🇪Wuppertal, Germany