Clinical trial NCT01078402: EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries
Official title: Evaluation of Clinical Outcome, Treatment Compliance and Tolerability of humIRA (Adalimumab) in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries; EviraEAST - a Multi-country, Multi-Center Post Marketing Observational Study in Routine Clinical Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis (AS)
Psoriatic Arthritis (PsA
Rheumatoid Arthritis (RA
Keywords: Treatment compliance and tolerability of Humira in patients
Eastern European countries
Rheumatoid Arthritis
Psoriatic Arthritis
Adalimumab
Ankylosing Spondylitis
Evaluation of clinical outcome
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of adult patients in Eastern European countries with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who can be administered Humira as per locally approved label.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA
timeFrame: Baseline, 3 months
measure: Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy
timeFrame: Baseline, 4, 7 and 13 months
measure: Participant Acceptability of Self-injection at Month 13 (End of Study)
timeFrame: 13 months
measure: Compliance With the Humira Administration Schedule at Month 13 (End of Study)
timeFrame: Month 13
measure: Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy
timeFrame: From first treatment until study discontinuation, up to 13 months.
measure: Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.
Other outcomes:
Locations:
city: Opatija
country: Croatia
facility: Site Reference ID/Investigator# 43283
city: Osijek
country: Croatia
facility: Site Reference ID/Investigator# 43282
city: Rijeka
country: Croatia
facility: Site Reference ID/Investigator# 43286
city: Split
country: Croatia
facility: Site Reference ID/Investigator# 43284
city: Zagreb
country: Croatia
facility: Site Reference ID/Investigator# 22405
city: Zagreb
country: Croatia
facility: Site Reference ID/Investigator# 43285
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32641
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32642
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32676
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32677
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32679
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32680
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32681
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32682
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32685
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32686
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32687
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32688
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32689
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32691
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32692
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32693
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32633
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32634
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32635
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32636
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32638
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32639
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32640
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32694
city: Budapest
country: Hungary
facility: Site Reference ID/Investigator# 32695
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32612
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32613
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32614
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32615
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32616
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32591
city: Debrecen
country: Hungary
facility: Site Reference ID/Investigator# 32592
city: Esztergom
country: Hungary
facility: Site Reference ID/Investigator# 32584
city: Esztergom
country: Hungary
facility: Site Reference ID/Investigator# 32585
city: Gyor
country: Hungary
facility: Site Reference ID/Investigator# 32629
city: Gyor
country: Hungary
facility: Site Reference ID/Investigator# 32630
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32696
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32697
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32698
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32699
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32700
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32701
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32702
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 32703
city: Heviz
country: Hungary
facility: Site Reference ID/Investigator# 32566
city: Kecskemet
country: Hungary
facility: Site Reference ID/Investigator# 32580
city: Kecskemet
country: Hungary
facility: Site Reference ID/Investigator# 32581
city: Kistarcsa
country: Hungary
facility: Site Reference ID/Investigator# 32582
city: Kistarcsa
country: Hungary
facility: Site Reference ID/Investigator# 32583
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 32624
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 32625
city: Miskolc
country: Hungary
facility: Site Reference ID/Investigator# 32626
city: Nyiregyhaza
country: Hungary
facility: Site Reference ID/Investigator# 32586
city: Nyiregyhaza
country: Hungary
facility: Site Reference ID/Investigator# 32588
city: Nyiregyhaza
country: Hungary
facility: Site Reference ID/Investigator# 32589
city: Nyiregyhaza
country: Hungary
facility: Site Reference ID/Investigator# 32590
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 32704
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 32705
city: Pecs
country: Hungary
facility: Site Reference ID/Investigator# 32709
city: Szeged
country: Hungary
facility: Site Reference ID/Investigator# 32617
city: Szeged
country: Hungary
facility: Site Reference ID/Investigator# 32618
city: Szeged
country: Hungary
facility: Site Reference ID/Investigator# 32619
city: Szekesfehervar
country: Hungary
facility: Site Reference ID/Investigator# 32627
city: Szekesfehervar
country: Hungary
facility: Site Reference ID/Investigator# 32628
city: Szolnok
country: Hungary
facility: Site Reference ID/Investigator# 32594
city: Szolnok
country: Hungary
facility: Site Reference ID/Investigator# 32595
city: Szombathely
country: Hungary
facility: Site Reference ID/Investigator# 32620
city: Szombathely
country: Hungary
facility: Site Reference ID/Investigator# 32622
city: Veszprem
country: Hungary
facility: Site Reference ID/Investigator# 32711
city: Veszprem
country: Hungary
facility: Site Reference ID/Investigator# 32712
city: Veszprem
country: Hungary
facility: Site Reference ID/Investigator# 32713
city: Ashkelon
country: Israel
facility: Site Reference ID/Investigator# 32079
city: Haifa
country: Israel
facility: Site Reference ID/Investigator# 32082
city: Haifa
country: Israel
facility: Site Reference ID/Investigator# 32080
city: Tel Hashomer
country: Israel
facility: Site Reference ID/Investigator# 32081
city: Tel Hashomer
country: Israel
facility: Site Reference ID/Investigator# 65468
city: Zrifin
country: Israel
facility: Site Reference ID/Investigator# 32078
city: Bytom
country: Poland
facility: Site Reference ID/Investigator# 32599
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 43251
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 32559
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 32560
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 43244
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 43252
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 43245
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 43246
city: Sopot
country: Poland
facility: Site Reference ID/Investigator# 32596
city: Sopot
country: Poland
facility: Site Reference ID/Investigator# 32597
city: Wrocław
country: Poland
facility: Site Reference ID/Investigator# 43250
city: Brasov
country: Romania
facility: Site Reference ID/Investigator# 31675
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 31678
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32568
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32569
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32570
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32571
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32098
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32099
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32575
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32576
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32577
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32578
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 31669
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 31670
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 31671
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 31672
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32094
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32090
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 32091
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 32100
city: Cluj-Napoca
country: Romania
facility: Site Reference ID/Investigator# 32097
city: Constanta
country: Romania
facility: Site Reference ID/Investigator# 32101
city: Constanta
country: Romania
facility: Site Reference ID/Investigator# 32103
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 31673
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 31674
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 19163
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 31668
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32114
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32115
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32116
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32117
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32118
city: Iasi
country: Romania
facility: Site Reference ID/Investigator# 32119
city: Piatra Neamt
country: Romania
facility: Site Reference ID/Investigator# 32112
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 32572
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 32573
city: Ploiesti
country: Romania
facility: Site Reference ID/Investigator# 32574
city: Sf. Gheorghe jud. Covasna
country: Romania
facility: Site Reference ID/Investigator# 31676
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 32104
city: Targu Mures
country: Romania
facility: Site Reference ID/Investigator# 32105
city: Timisoara
country: Romania
facility: Site Reference ID/Investigator# 32108
city: Timisoara
country: Romania
facility: Site Reference ID/Investigator# 32113
city: Banska Bystrica
country: Slovakia
facility: Site Reference ID/Investigator# 19164
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 43262
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 43263
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 43242
city: Dnipropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 48364
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 31693
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 31685
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 31690
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 31686
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31679
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31680
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31684
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31682
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31683
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 48363
city: Kryvyi Rih
country: Ukraine
facility: Site Reference ID/Investigator# 48365
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 48366
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 48367
city: Lviv
country: Ukraine
facility: Site Reference ID/Investigator# 48368
city: Odessa
country: Ukraine
facility: Site Reference ID/Investigator# 31689
city: Simferopol
country: Ukraine
facility: Site Reference ID/Investigator# 31694
city: Uzhgorod
country: Ukraine
facility: Site Reference ID/Investigator# 43243
city: Uzhgorod
country: Ukraine
facility: Site Reference ID/Investigator# 48369
city: Uzhgorod
country: Ukraine
facility: Site Reference ID/Investigator# 48370
city: Vinnitsa
country: Ukraine
facility: Site Reference ID/Investigator# 31691
city: Zaporogzhe
country: Ukraine
facility: Site Reference ID/Investigator# 31692
city: Zhytomyr
country: Ukraine
facility: Site Reference ID/Investigator# 48371
Study officials:
affiliation: AbbVie
name: Maja Hojnik
role: STUDY_DIRECTOR
References: