UpSPINE: A Study to Assess Disease Activity in Adult Participants With Ankylosing Spondylitis Who Receive Upadacitinib in a Real-world Setting

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05094128

Collaborator

(none)

352

Enrollment

Locations

36.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis [AS]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 352 adult participants with active r-axSpA will be enrolled in Germany.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 52 weeks.

There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Radiographic Axial Spondylarthritis (r-axSpA)	Drug: Upadacitinib

Study Design

Study Type:

Observational

Anticipated Enrollment :

352 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effectiveness of Upadacitinib in Patients With Ankylosing Spondylitis Suffering From Typical Disease Activity and Pain in a Real-World Setting

Actual Study Start Date :

Nov 22, 2021

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants Receiving Upadacitinib	Drug: Upadacitinib Tablet; Oral Other Names: RINVOQ

Arm

Intervention/Treatment

Participants Receiving Upadacitinib

Drug: Upadacitinib

Tablet; Oral

Other Names:

RINVOQ

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) [Week 24]
The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS < 2.1.
Percentage of Participants Achieving ASDAS LDA (< 2.1) (i.e., Maintenance of Response) [Up to Week 52]
The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Low disease is defined as an ASDAS < 2.1. Maintenance of response is defined as those achieving LDA at Week 24 and Week 52.

Secondary Outcome Measures

Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of 40 [Up to Week 52]
The ASAS-HI has been developed to measure functioning and health in patients with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the International Classification of Functioning, Disability and Health (ICF).
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score < 4 [Up to Week 52]
The BASDAI is a commonly used measure to define disease activity levels in r-axSpA patients. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Percentage of Participants Achieving ASDAS Inactive Disease (ID [< 1.3]) [Up to Week 52]
The ASDAS combines the following 5 disease activity variables: back pain (BASDAI Question 2 NRS score 0 - 10), peripheral pain/swelling (BASDAI Question 3 NRS score 0 - 10), duration of morning stiffness (BASDAI Question 6 NRS score 0 - 10), PtGA, and high-sensitivity c reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). Inactive disease is defined as an ASDAS < 1.3.
Percentage of Participants Achieving ASDAS LDA (< 2.1) [Up to Week 52]
The ASDAS is a composite index with proven validity and reliability to assess disease activity in r-axSpA participants, with LDA defined as a score < 2.1.
Change from Baseline in BASDAI [Up to Week 52]
The BASDAI is a commonly used measure to define disease activity levels in r-axSpA patients. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Change from Baseline in BASDAI at Week 1-4 [Week 4]
The BASDAI is a commonly used measure to define disease activity levels in r-axSpA patients. The overall BASDAI score ranges from 0 to 10, with higher scores indicating greater disease activity.
Percentage of Participants with Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) for Participants with Baseline Enthesitis [Up to Week 52]
The LEI is a clinical index used to assess enthesitis. It consists of 3 bilateral sites: Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified on a dichotomous basis: 0 means nontender and 1 means tender.
Percentage of Participants with Resolution of Dactylitis for Participants with Baseline Dactylitis [Up to Week 52]
Presence of dactylitis (Yes/No) will be assessed by the physician.
Mean Change from Baseline in ASAS-HI [Up to Week 52]
The ASAS-HI has been developed to measure functioning and health in patients with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the ICF.
Percentage of Participants with ASAS-HI <= 4 [Up to Week 52]
The ASAS-HI has been developed to measure functioning and health in patients with SpA with the aim of defining and comparing the impact of the disease and health based on the biopsychosocial model of disease proposed by the ICF.
Mean Change from Baseline in Nocturnal Back Pain in Past 24 Hours [Up to Week 52]
Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).
Mean Change from Baseline in Total Back Pain in Past 24 Hours [Up to Week 52]
Pain will be measured using a 0 - 10 numerical rating scale (NRS) for nocturnal back pain (0 = no pain and 10 = most severe pain).
Mean Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Up to Week 52]
The BASFI is a validated PRO instrument for use in the r-axSpA patient population. It consists of 10 items measured on a 0 to 10 NRS, which assesses the ability to perform activities known to be problematic to r-axSpA patients such as dressing, bending, reaching, turning, and climbing steps. The total scores range from 0 to 10 with higher scores indicating worse physical functioning in r-axSpA patients.
Mean Change from Baseline in Patient Health Questionnaire-4 (PHQ-4) [Up to Week 52]
The 4-item PHQ-4 is an ultra-brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). It is rated on a 4-point Likert-type scale. Its purpose is to allow for very brief and accurate measurement of depression and anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of r-axSpA upon physician's judgement.
Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
Upadacitinib prescribed in accordance with the local label.

Exclusion Criteria:

Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).
Participants with primary fibromyalgia (upon physician´s judgement)
Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
Participants who cannot be treated with upadacitinib according to the applicable local label.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxis Dr. Rinaldi /ID# 242984	Ulm	Baden-Wuerttemberg	Germany	89073
2	Praxis Dres. Kellerer/Kellerer/Krüger /ID# 240478	Munich	Bayern	Germany	81541
3	Rheumahaus Studien GbR, Potsdam, DE /ID# 245231	Potsdam	Brandenburg	Germany	14467
4	Internistisches Praxiszentrum /ID# 240491	Gießen	Hessen	Germany	35392
5	Fachpraxis fuer Rheumatologie und Osteologie /ID# 243358	Bruchhausen-Vilsen	Niedersachsen	Germany	27305
6	Rheumazentrum Ruhrgebiet /ID# 240137	Herne	Nordrhein-Westfalen	Germany	44649
7	Rheumazentrum Ruhrgebiet /ID# 240460	Herne	Nordrhein-Westfalen	Germany	44649
8	Kupka & Kupka, Altenburg, DE /ID# 240479	Altenburg		Germany	04600
9	Marycz, Amberg, DE /ID# 240483	Amberg		Germany	92224
10	Rheumapraxis am Webereck /ID# 240454	Augsburg		Germany	86157
11	Praxis S. Bresgulewski /ID# 240662	Bad Bertrich		Germany	56864
12	MVZ Weserbergland /ID# 240486	Bad Pyrmont		Germany	31812
13	ACURA Rheumazentrum Baden-Bade /ID# 240487	Baden-baden		Germany	76530
14	Internistische-rheumatologische Praxisgemeinschaft /ID# 240496	Bayreuth		Germany	95444
15	MVZ Rheumatologie /ID# 240614	Berlin		Germany	10117
16	Praxis fuer Rheumatologie und Innere Medizin /ID# 240457	Berlin		Germany	12163
17	Rheumapraxis Berlin /ID# 242987	Berlin		Germany	12435
18	Praxis Dr. med. Angela Seifert /ID# 245107	Berlin		Germany	12555
19	Praxis Dr. Silke Zinke /ID# 240526	Berlin		Germany	13055
20	Eisterhues, Braunschweig, DE /ID# 239438	Braunschweig		Germany	38100
21	Schwerpunktpraxis fuer Rheumat /ID# 240450	Burghausen		Germany	84489
22	Med Versorgungszentrum AGILOMED /ID# 240481	Chemnitz		Germany	09130
23	Dres. Schuh /ID# 240498	Coburg		Germany	96450
24	Dres. Karger/Baerlecken /ID# 240442	Cologne		Germany	50996
25	Krankenhaus Porz am Rhein /ID# 243765	Cologne		Germany	51149
26	Kreiskrankenhaus Demmin /ID# 240451	Demmin		Germany	17109
27	Rheumatologisches MVZ Dresden /ID# 240516	Dresden		Germany	01109
28	Rheumapraxis Düren /ID# 240447	Düren		Germany	52355
29	Praxis Dilltal /ID# 240520	Ehringshausen		Germany	35630
30	MVZ Ambulantes Rheumazentrum Erfurt /ID# 244448	Erfurt		Germany	99096
31	Michael Mueller, Freiberg, DE /ID# 240489	Freiberg		Germany	09599
32	Praxis Dres. Sensse/Sensse /ID# 240517	Gifhorn		Germany	38518
33	Universitaetsmedizin Goettingen /ID# 240138	Goettingen		Germany	37075
34	Praxis Dr. Liebhaber /ID# 240480	Halle		Germany	06128
35	Dres. Weinhardt/Knobel/Doepfer /ID# 248195	Hamburg		Germany	22523
36	Zentrum fuer Rheumatologie und Schmerzmedizin /ID# 244370	Hanover		Germany	30159
37	Heilig, Heidelberg, DE /ID# 240492	Heidelberg		Germany	69120
38	Praxis Bernd Mueller /ID# 240488	Homburg		Germany	66424
39	Praxis K. Pagel /ID# 240490	Hoppegarten		Germany	15366
40	Kremers, Juelich, DE /ID# 243357	Juelich		Germany	52428
41	Beyer, Kaiserslautern, DE /ID# 240444	Kaiserslautern		Germany	67659
42	Alb-Donau Klinikum, Langenau /ID# 240446	Langenau		Germany	89129
43	Hamann & Teich & Boche,Leipzig /ID# 240445	Leipzig		Germany	04109
44	Praxis internistische Rheumatologie /ID# 240515	Leipzig		Germany	04129
45	Aurich & Sieburg, Magdeburg /ID# 240518	Magdeburg		Germany	39104
46	Praxis Dr. Annekatrin Rossbach /ID# 240495	Mansfeld / Großörner		Germany	06343
47	Harmuth, Marktredwitz, DE /ID# 240455	Marktredwitz		Germany	95615
48	RHIO Forschungsinstitut /ID# 240525	Meerbusch		Germany	40668
49	Prof-med-stud.de /ID# 240458	Munich		Germany	80935
50	Rheumatologische Facharztpraxis /ID# 240477	Naumburg (Saale)		Germany	06618
51	Praxis Dr. med Thilo Klopsch /ID# 240461	Neubrandenburg		Germany	17033
52	Praxis Hein & Gess /ID# 240456	Nienburg		Germany	31582
53	MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 240521	Planegg		Germany	82152
54	Baumann & Lang, Plauen, DE /ID# 244369	Plauen		Germany	08523
55	Praxis Dr. Sabine Reckert /ID# 245142	Potsdam		Germany	14469
56	Rheumapraxis Dr. Prothmann /ID# 240671	Püttlingen		Germany	66346
57	Rheumazentrum Ratingen /ID# 240465	Ratingen		Germany	40882
58	Rheumatologische Gemeinschaftspraxis Schwerin /ID# 240463	Schwerin		Germany	19053
59	Melzer, Seesen, DE /ID# 240484	Seesen		Germany	38723
60	Rheumapraxis Magdea /ID# 240482	Stadtoldendorf		Germany	37627
61	Barmherzige Bruder MVZ Klinikum Straubing GmbH /ID# 240523	Straubing		Germany	94315
62	Rheumatologische Schwerpunktpraxis /ID# 240564	Stuttgart		Germany	70372
63	Rheumatologische Schwerpunktpraxis /ID# 245392	Stuttgart		Germany	70372
64	Krankenhaus der Barmherzigen Brueder Trier /ID# 240524	Trier		Germany	54292
65	Praxis Dr. Haas /ID# 242982	Tuebingen		Germany	72072
66	Rheumathologie Ulm /ID# 240494	Ulm		Germany	89073
67	Krankenhaus St. Josef /ID# 240522	Wuppertal		Germany	42105
68	Praxis Barmen /ID# 240449	Wuppertal		Germany	42285
69	Sprekeler, Zeven, DE /ID# 240519	Zeven		Germany	27404
70	Fricke-Wagner, Zwickau, DE /ID# 240452	Zwickau		Germany	08060