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EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

NCT ID: NCT01078402

Last Updated: 2013-02-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

809 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-11-30

Brief Summary

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This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.

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Detailed Description

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This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format. The assignment of the patient to Humira is not decided in advance by this protocol but falls within the current practice. The prescription of Humira is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients. As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 14-17 months period (including tuberculosis (TB) screening and prophylaxis, if indicated), which defines the survey for each patient. The TB screening period per patient will be 1-4 weeks and, if applicable, the TB prophylactic treatment period before Humira administration will be 1 month in accordance with local guidelines. For indicative purposes, follow-up of patients should entail approximately 7 patient visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following TB screening. The first visit following introduction of Humira and final visits are required because of intercurrent events. If treatment with Humira is discontinued, the standard practice is to review the patient after a period of 70 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. If the physician decides to permanently discontinue Humira before the end of the planned observational period of 13 months, the reason for discontinuation and the new treatment regimen prescribed, if applicable, will be documented. The next routine follow-up visit will be the termination visit for this patient in the PMOS.

Conditions

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Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA Rheumatoid Arthritis (RA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single patients group: RA, PsA and AS

Single patients group with: Active Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria:

* Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR
* Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira thereafter.

Exclusion Criteria

* Patients who are being treated or will be treated with drugs at risk of interactions with Humira (see Humira Summary of Product Characteristics)
* Patients currently participating in another clinical trial
* Patients with diagnosis of active tuberculosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maja Hojnik

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 43283

Opatija, , Croatia

Site Status

Site Reference ID/Investigator# 43282

Osijek, , Croatia

Site Status

Site Reference ID/Investigator# 43286

Rijeka, , Croatia

Site Status

Site Reference ID/Investigator# 43284

Split, , Croatia

Site Status

Site Reference ID/Investigator# 22405

Zagreb, , Croatia

Site Status

Site Reference ID/Investigator# 43285

Zagreb, , Croatia

Site Status

Site Reference ID/Investigator# 32641

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32642

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32676

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32677

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32679

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32680

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32681

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32682

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32685

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32686

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32687

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32688

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32689

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32691

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32692

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32693

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32633

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32634

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32635

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32636

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32638

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32639

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32640

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32694

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32695

Budapest, , Hungary

Site Status

Site Reference ID/Investigator# 32612

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32613

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32614

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32615

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32616

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32591

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32592

Debrecen, , Hungary

Site Status

Site Reference ID/Investigator# 32584

Esztergom, , Hungary

Site Status

Site Reference ID/Investigator# 32585

Esztergom, , Hungary

Site Status

Site Reference ID/Investigator# 32629

Győr, , Hungary

Site Status

Site Reference ID/Investigator# 32630

Győr, , Hungary

Site Status

Site Reference ID/Investigator# 32696

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32697

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32698

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32699

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32700

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32701

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32702

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32703

Gyula, , Hungary

Site Status

Site Reference ID/Investigator# 32566

Hévíz, , Hungary

Site Status

Site Reference ID/Investigator# 32580

Kecskemét, , Hungary

Site Status

Site Reference ID/Investigator# 32581

Kecskemét, , Hungary

Site Status

Site Reference ID/Investigator# 32582

Kistarcsa, , Hungary

Site Status

Site Reference ID/Investigator# 32583

Kistarcsa, , Hungary

Site Status

Site Reference ID/Investigator# 32624

Miskolc, , Hungary

Site Status

Site Reference ID/Investigator# 32625

Miskolc, , Hungary

Site Status

Site Reference ID/Investigator# 32626

Miskolc, , Hungary

Site Status

Site Reference ID/Investigator# 32586

Nyíregyháza, , Hungary

Site Status

Site Reference ID/Investigator# 32588

Nyíregyháza, , Hungary

Site Status

Site Reference ID/Investigator# 32589

Nyíregyháza, , Hungary

Site Status

Site Reference ID/Investigator# 32590

Nyíregyháza, , Hungary

Site Status

Site Reference ID/Investigator# 32704

Pécs, , Hungary

Site Status

Site Reference ID/Investigator# 32705

Pécs, , Hungary

Site Status

Site Reference ID/Investigator# 32709

Pécs, , Hungary

Site Status

Site Reference ID/Investigator# 32617

Szeged, , Hungary

Site Status

Site Reference ID/Investigator# 32618

Szeged, , Hungary

Site Status

Site Reference ID/Investigator# 32619

Szeged, , Hungary

Site Status

Site Reference ID/Investigator# 32627

Székesfehérvár, , Hungary

Site Status

Site Reference ID/Investigator# 32628

Székesfehérvár, , Hungary

Site Status

Site Reference ID/Investigator# 32594

Szolnok, , Hungary

Site Status

Site Reference ID/Investigator# 32595

Szolnok, , Hungary

Site Status

Site Reference ID/Investigator# 32620

Szombathely, , Hungary

Site Status

Site Reference ID/Investigator# 32622

Szombathely, , Hungary

Site Status

Site Reference ID/Investigator# 32711

Veszprém, , Hungary

Site Status

Site Reference ID/Investigator# 32712

Veszprém, , Hungary

Site Status

Site Reference ID/Investigator# 32713

Veszprém, , Hungary

Site Status

Site Reference ID/Investigator# 32079

Ashkelon, , Israel

Site Status

Site Reference ID/Investigator# 32082

Haifa, , Israel

Site Status

Site Reference ID/Investigator# 32080

Haifa, , Israel

Site Status

Site Reference ID/Investigator# 32081

Tel Litwinsky, , Israel

Site Status

Site Reference ID/Investigator# 65468

Tel Litwinsky, , Israel

Site Status

Site Reference ID/Investigator# 32078

Zrifin, , Israel

Site Status

Site Reference ID/Investigator# 32599

Bytom, , Poland

Site Status

Site Reference ID/Investigator# 43251

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 32559

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 32560

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 43244

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 43252

Krakow, , Poland

Site Status

Site Reference ID/Investigator# 43245

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 43246

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 32596

Sopot, , Poland

Site Status

Site Reference ID/Investigator# 32597

Sopot, , Poland

Site Status

Site Reference ID/Investigator# 43250

Wroclaw, , Poland

Site Status

Site Reference ID/Investigator# 31675

Brasov, , Romania

Site Status

Site Reference ID/Investigator# 31678

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32568

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32569

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32570

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32571

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32098

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32099

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32575

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32576

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32577

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32578

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 31669

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 31670

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 31671

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 31672

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32094

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32090

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32091

Bucharest, , Romania

Site Status

Site Reference ID/Investigator# 32100

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 32097

Cluj-Napoca, , Romania

Site Status

Site Reference ID/Investigator# 32101

Constanța, , Romania

Site Status

Site Reference ID/Investigator# 32103

Constanța, , Romania

Site Status

Site Reference ID/Investigator# 31673

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 31674

Craiova, , Romania

Site Status

Site Reference ID/Investigator# 19163

Iași, , Romania

Site Status

Site Reference ID/Investigator# 31668

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32114

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32115

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32116

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32117

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32118

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32119

Iași, , Romania

Site Status

Site Reference ID/Investigator# 32112

Piatra Neamţ, , Romania

Site Status

Site Reference ID/Investigator# 32572

Ploieşti, , Romania

Site Status

Site Reference ID/Investigator# 32573

Ploieşti, , Romania

Site Status

Site Reference ID/Investigator# 32574

Ploieşti, , Romania

Site Status

Site Reference ID/Investigator# 31676

Sf. Gheorghe Jud. Covasna, , Romania

Site Status

Site Reference ID/Investigator# 32104

Târgu Mureş, , Romania

Site Status

Site Reference ID/Investigator# 32105

Târgu Mureş, , Romania

Site Status

Site Reference ID/Investigator# 32108

Timișoara, , Romania

Site Status

Site Reference ID/Investigator# 32113

Timișoara, , Romania

Site Status

Site Reference ID/Investigator# 19164

Banská Bystrica, , Slovakia

Site Status

Site Reference ID/Investigator# 43262

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 43263

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 43242

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 48364

Dnipropetrovsk, , Ukraine

Site Status

Site Reference ID/Investigator# 31693

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 31685

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 31690

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 31686

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 31679

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 31680

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 31684

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 31682

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 31683

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 48363

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 48365

Kryvyi Rih, , Ukraine

Site Status

Site Reference ID/Investigator# 48366

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 48367

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 48368

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 31689

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 31694

Simferopol, , Ukraine

Site Status

Site Reference ID/Investigator# 43243

Uzhhorod, , Ukraine

Site Status

Site Reference ID/Investigator# 48369

Uzhhorod, , Ukraine

Site Status

Site Reference ID/Investigator# 48370

Uzhhorod, , Ukraine

Site Status

Site Reference ID/Investigator# 31691

Vinnitsa, , Ukraine

Site Status

Site Reference ID/Investigator# 31692

Zaporogzhe, , Ukraine

Site Status

Site Reference ID/Investigator# 48371

Zhytomyr, , Ukraine

Site Status

Countries

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Croatia Hungary Israel Poland Romania Slovakia Ukraine

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P10-919

Identifier Type: -

Identifier Source: org_study_id

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