A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life

NCT ID: NCT02354105

Last Updated: 2019-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

680 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-12

Study Completion Date

2018-03-09

Brief Summary

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The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.

Detailed Description

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Conditions

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Axial Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CZP treatment

axSpA patients who have been newly prescribed Certolizumab Pegol (CZP).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit 2. No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
* The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), \[ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)\] according to the diagnostic criteria used by the physician in routine clinical practice.
* The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
* The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4).
* Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
* If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.

Exclusion Criteria

N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273 (UCB)

Locations

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406

Middlesbrough, , United Kingdom

Site Status

602

Brussels, , Belgium

Site Status

604

Edegem, , Belgium

Site Status

601

Genk, , Belgium

Site Status

603

Heusy, , Belgium

Site Status

53

Altenburg, , Germany

Site Status

18

Bayreuth, , Germany

Site Status

6

Bayreuth, , Germany

Site Status

13

Berlin, , Germany

Site Status

14

Berlin, , Germany

Site Status

16

Berlin, , Germany

Site Status

30

Berlin, , Germany

Site Status

7

Berlin, , Germany

Site Status

4

Burghausen, , Germany

Site Status

25

Chemnitz, , Germany

Site Status

50

Cottbus, , Germany

Site Status

11

Dresden, , Germany

Site Status

8

Düsseldorf, , Germany

Site Status

36

Elmshorn, , Germany

Site Status

35

Erfurt, , Germany

Site Status

19

Freiburg im Breisgau, , Germany

Site Status

41

Goslar, , Germany

Site Status

26

Greifswald, , Germany

Site Status

32

Halle, , Germany

Site Status

23

Hamburg, , Germany

Site Status

47

Hamburg, , Germany

Site Status

1

Hanover, , Germany

Site Status

44

Hanover, , Germany

Site Status

42

Heidelberg, , Germany

Site Status

10

Herne, , Germany

Site Status

40

Hofheim am Taunus, , Germany

Site Status

34

Hoyerswerda, , Germany

Site Status

27

Karlsruhe, , Germany

Site Status

48

Karlstadt am Main, , Germany

Site Status

49

Karlstadt am Main, , Germany

Site Status

21

Leipzig, , Germany

Site Status

38

Leipzig, , Germany

Site Status

9

Magdeburg, , Germany

Site Status

29

Marktredwitz, , Germany

Site Status

31

München, , Germany

Site Status

43

München, , Germany

Site Status

2

Naunhof, , Germany

Site Status

20

Planegg, , Germany

Site Status

24

Potsdam, , Germany

Site Status

15

Püttlingen, , Germany

Site Status

28

Saarbrücken, , Germany

Site Status

51

Wuppertal, , Germany

Site Status

39

Zwickau, , Germany

Site Status

202

Athens, , Greece

Site Status

210

Athens, , Greece

Site Status

211

Athens, , Greece

Site Status

212

Athens, , Greece

Site Status

207

Larissa, , Greece

Site Status

208

Marousi, , Greece

Site Status

201

Pátrai, , Greece

Site Status

203

Thessaloniki, , Greece

Site Status

204

Thessaloniki, , Greece

Site Status

205

Thessaloniki, , Greece

Site Status

206

Thessaloniki, , Greece

Site Status

504

Florence, , Italy

Site Status

501

Palermo, , Italy

Site Status

502

Potenza, , Italy

Site Status

505

Roma, , Italy

Site Status

500

Siena, , Italy

Site Status

503

Verona, , Italy

Site Status

116

Barcelona, , Spain

Site Status

114

Bilbao, , Spain

Site Status

122

Cartagena, , Spain

Site Status

108

Córdoba, , Spain

Site Status

118

Donostia / San Sebastian, , Spain

Site Status

120

Granada, , Spain

Site Status

107

León, , Spain

Site Status

123

Lorca, , Spain

Site Status

101

Mérida, , Spain

Site Status

119

Murcia, , Spain

Site Status

117

Salamanca, , Spain

Site Status

121

Sant Joan Despí, , Spain

Site Status

112

Tarragona, , Spain

Site Status

115

Terrassa, , Spain

Site Status

416

Barnsley, , United Kingdom

Site Status

405

Basingstoke, , United Kingdom

Site Status

401

Bath, , United Kingdom

Site Status

423

Bolton, , United Kingdom

Site Status

421

Christchurch, , United Kingdom

Site Status

403

Hull, , United Kingdom

Site Status

420

Leeds, , United Kingdom

Site Status

415

Leicester, , United Kingdom

Site Status

409

Liverpool, , United Kingdom

Site Status

422

Llandudno, , United Kingdom

Site Status

411

Luton, , United Kingdom

Site Status

414

Manchester, , United Kingdom

Site Status

424

North Shields, , United Kingdom

Site Status

413

Norwich, , United Kingdom

Site Status

410

Preston, , United Kingdom

Site Status

412

Southampton, , United Kingdom

Site Status

419

Stevenage, , United Kingdom

Site Status

418

Sunderland, , United Kingdom

Site Status

408

Torquay, , United Kingdom

Site Status

407

Truro, , United Kingdom

Site Status

425

Wigan, , United Kingdom

Site Status

Countries

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Belgium Germany Greece Italy Spain United Kingdom

Other Identifiers

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AS0002

Identifier Type: -

Identifier Source: org_study_id

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