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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis (AS); Psoriatic Arthritis (PsA; Rheumatoid Arthritis (RA

Phase: N/A

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Maja Hojnik, Study Director, Affiliation: AbbVie

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.

Clinical Details

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 design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA

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

Secondary outcome:

Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy

Participant Acceptability of Self-injection at Month 13 (End of Study)

Compliance With the Humira Administration Schedule at Month 13 (End of Study)

Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy

Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Site Reference ID/Investigator# 43283, Opatija 51410, Croatia

Site Reference ID/Investigator# 43282, Osijek 31000, Croatia

Site Reference ID/Investigator# 43286, Rijeka 51 000, Croatia

Site Reference ID/Investigator# 43284, Split 21000, Croatia

Site Reference ID/Investigator# 22405, Zagreb 10000, Croatia

Site Reference ID/Investigator# 43285, Zagreb 10000, Croatia

Site Reference ID/Investigator# 32633, Budapest 1027, Hungary

Site Reference ID/Investigator# 32634, Budapest 1027, Hungary

Site Reference ID/Investigator# 32635, Budapest 1027, Hungary

Site Reference ID/Investigator# 32636, Budapest 1027, Hungary

Site Reference ID/Investigator# 32638, Budapest 1027, Hungary

Site Reference ID/Investigator# 32639, Budapest 1027, Hungary

Site Reference ID/Investigator# 32640, Budapest 1027, Hungary

Site Reference ID/Investigator# 32641, Budapest 1023, Hungary

Site Reference ID/Investigator# 32642, Budapest 1023, Hungary

Site Reference ID/Investigator# 32676, Budapest 1023, Hungary

Site Reference ID/Investigator# 32677, Budapest 1023, Hungary

Site Reference ID/Investigator# 32679, Budapest 1023, Hungary

Site Reference ID/Investigator# 32680, Budapest 1023, Hungary

Site Reference ID/Investigator# 32681, Budapest 1023, Hungary

Site Reference ID/Investigator# 32682, Budapest 1023, Hungary

Site Reference ID/Investigator# 32685, Budapest 1023, Hungary

Site Reference ID/Investigator# 32686, Budapest 1023, Hungary

Site Reference ID/Investigator# 32687, Budapest 1023, Hungary

Site Reference ID/Investigator# 32688, Budapest 1023, Hungary

Site Reference ID/Investigator# 32689, Budapest 1023, Hungary

Site Reference ID/Investigator# 32691, Budapest 1023, Hungary

Site Reference ID/Investigator# 32692, Budapest 1023, Hungary

Site Reference ID/Investigator# 32693, Budapest 1023, Hungary

Site Reference ID/Investigator# 32694, Budapest 1062, Hungary

Site Reference ID/Investigator# 32695, Budapest 1062, Hungary

Site Reference ID/Investigator# 32591, Debrecen 4043, Hungary

Site Reference ID/Investigator# 32592, Debrecen 4043, Hungary

Site Reference ID/Investigator# 32612, Debrecen 4032, Hungary

Site Reference ID/Investigator# 32613, Debrecen 4032, Hungary

Site Reference ID/Investigator# 32614, Debrecen 4032, Hungary

Site Reference ID/Investigator# 32615, Debrecen 4032, Hungary

Site Reference ID/Investigator# 32616, Debrecen 4032, Hungary

Site Reference ID/Investigator# 32584, Esztergom 2500, Hungary

Site Reference ID/Investigator# 32585, Esztergom 2500, Hungary

Site Reference ID/Investigator# 32629, Gyor 9023, Hungary

Site Reference ID/Investigator# 32630, Gyor 9023, Hungary

Site Reference ID/Investigator# 32696, Gyula 5700, Hungary

Site Reference ID/Investigator# 32697, Gyula 5700, Hungary

Site Reference ID/Investigator# 32698, Gyula 5700, Hungary

Site Reference ID/Investigator# 32699, Gyula 5700, Hungary

Site Reference ID/Investigator# 32700, Gyula 5700, Hungary

Site Reference ID/Investigator# 32701, Gyula 5700, Hungary

Site Reference ID/Investigator# 32702, Gyula 5700, Hungary

Site Reference ID/Investigator# 32703, Gyula 5700, Hungary

Site Reference ID/Investigator# 32566, Heviz 8381, Hungary

Site Reference ID/Investigator# 32580, Kecskemet 6000, Hungary

Site Reference ID/Investigator# 32581, Kecskemet 6000, Hungary

Site Reference ID/Investigator# 32582, Kistarcsa 2143, Hungary

Site Reference ID/Investigator# 32583, Kistarcsa 2143, Hungary

Site Reference ID/Investigator# 32624, Miskolc 3529, Hungary

Site Reference ID/Investigator# 32625, Miskolc 3529, Hungary

Site Reference ID/Investigator# 32626, Miskolc 3529, Hungary

Site Reference ID/Investigator# 32586, Nyiregyhaza 4400, Hungary

Site Reference ID/Investigator# 32588, Nyiregyhaza 4400, Hungary

Site Reference ID/Investigator# 32589, Nyiregyhaza 4400, Hungary

Site Reference ID/Investigator# 32590, Nyiregyhaza 4400, Hungary

Site Reference ID/Investigator# 32704, Pecs 7643, Hungary

Site Reference ID/Investigator# 32705, Pecs 7643, Hungary

Site Reference ID/Investigator# 32709, Pecs 7643, Hungary

Site Reference ID/Investigator# 32617, Szeged 6722, Hungary

Site Reference ID/Investigator# 32618, Szeged 6722, Hungary

Site Reference ID/Investigator# 32619, Szeged 6722, Hungary

Site Reference ID/Investigator# 32627, Szekesfehervar 8000, Hungary

Site Reference ID/Investigator# 32628, Szekesfehervar 8000, Hungary

Site Reference ID/Investigator# 32594, Szolnok 5000, Hungary

Site Reference ID/Investigator# 32595, Szolnok 5000, Hungary

Site Reference ID/Investigator# 32620, Szombathely 9702, Hungary

Site Reference ID/Investigator# 32622, Szombathely 9702, Hungary

Site Reference ID/Investigator# 32711, Veszprem 8200, Hungary

Site Reference ID/Investigator# 32712, Veszprem 8200, Hungary

Site Reference ID/Investigator# 32713, Veszprem 8200, Hungary

Site Reference ID/Investigator# 32079, Ashkelon 78287, Israel

Site Reference ID/Investigator# 32080, Haifa 34362, Israel

Site Reference ID/Investigator# 32082, Haifa 31096, Israel

Site Reference ID/Investigator# 32081, Tel Hashomer 52621, Israel

Site Reference ID/Investigator# 65468, Tel Hashomer 52621, Israel

Site Reference ID/Investigator# 32078, Zrifin 70300, Israel

Site Reference ID/Investigator# 32599, Bytom 41-900, Poland

Site Reference ID/Investigator# 32559, Krakow 31-121, Poland

Site Reference ID/Investigator# 32560, Krakow 31-121, Poland

Site Reference ID/Investigator# 43244, Krakow 31-501, Poland

Site Reference ID/Investigator# 43251, Krakow 30-119, Poland

Site Reference ID/Investigator# 43252, Krakow 31-501, Poland

Site Reference ID/Investigator# 43245, Poznan 61-545, Poland

Site Reference ID/Investigator# 43246, Poznan 61-545, Poland

Site Reference ID/Investigator# 32596, Sopot 81-759, Poland

Site Reference ID/Investigator# 32597, Sopot 81-759, Poland

Site Reference ID/Investigator# 43250, Wrocław 53-114, Poland

Site Reference ID/Investigator# 31675, Brasov 500097, Romania

Site Reference ID/Investigator# 31669, Bucharest 020983, Romania

Site Reference ID/Investigator# 31670, Bucharest 020983, Romania

Site Reference ID/Investigator# 31671, Bucharest 020983, Romania

Site Reference ID/Investigator# 31672, Bucharest 020983, Romania

Site Reference ID/Investigator# 31678, Bucharest 010195, Romania

Site Reference ID/Investigator# 32090, Bucharest 20125, Romania

Site Reference ID/Investigator# 32091, Bucharest 20125, Romania

Site Reference ID/Investigator# 32094, Bucharest 040101, Romania

Site Reference ID/Investigator# 32098, Bucharest 020475, Romania

Site Reference ID/Investigator# 32099, Bucharest 020475, Romania

Site Reference ID/Investigator# 32568, Bucharest 011172, Romania

Site Reference ID/Investigator# 32569, Bucharest 011172, Romania

Site Reference ID/Investigator# 32570, Bucharest 011172, Romania

Site Reference ID/Investigator# 32571, Bucharest 011172, Romania

Site Reference ID/Investigator# 32575, Bucharest 020475, Romania

Site Reference ID/Investigator# 32576, Bucharest 020475, Romania

Site Reference ID/Investigator# 32577, Bucharest 020475, Romania

Site Reference ID/Investigator# 32578, Bucharest 020475, Romania

Site Reference ID/Investigator# 32097, Cluj-Napoca 400132, Romania

Site Reference ID/Investigator# 32100, Cluj-Napoca 400006, Romania

Site Reference ID/Investigator# 32101, Constanta 900709, Romania

Site Reference ID/Investigator# 32103, Constanta 900709, Romania

Site Reference ID/Investigator# 31673, Craiova 200374, Romania

Site Reference ID/Investigator# 31674, Craiova 200374, Romania

Site Reference ID/Investigator# 19163, Iasi 700106, Romania

Site Reference ID/Investigator# 31668, Iasi 700661, Romania

Site Reference ID/Investigator# 32114, Iasi 700661, Romania

Site Reference ID/Investigator# 32115, Iasi 700661, Romania

Site Reference ID/Investigator# 32116, Iasi 700661, Romania

Site Reference ID/Investigator# 32117, Iasi 700661, Romania

Site Reference ID/Investigator# 32118, Iasi 700661, Romania

Site Reference ID/Investigator# 32119, Iasi 700661, Romania

Site Reference ID/Investigator# 32112, Piatra Neamt 610017, Romania

Site Reference ID/Investigator# 32572, Ploiesti 100337, Romania

Site Reference ID/Investigator# 32573, Ploiesti 100337, Romania

Site Reference ID/Investigator# 32574, Ploiesti 100337, Romania

Site Reference ID/Investigator# 31676, Sf. Gheorghe jud. Covasna 520064, Romania

Site Reference ID/Investigator# 32104, Targu Mures 540136, Romania

Site Reference ID/Investigator# 32105, Targu Mures 540136, Romania

Site Reference ID/Investigator# 32108, Timisoara 300020, Romania

Site Reference ID/Investigator# 32113, Timisoara 300150, Romania

Site Reference ID/Investigator# 19164, Banska Bystrica 974 05, Slovakia

Site Reference ID/Investigator# 43262, Bratislava 826 06, Slovakia

Site Reference ID/Investigator# 43263, Kosice 041 90, Slovakia

Site Reference ID/Investigator# 43242, Dnepropetrovsk 49068, Ukraine

Site Reference ID/Investigator# 48364, Dnipropetrovsk 49005, Ukraine

Site Reference ID/Investigator# 31685, Donetsk 83045, Ukraine

Site Reference ID/Investigator# 31693, Donetsk 83000, Ukraine

Site Reference ID/Investigator# 31686, Kharkov 61024, Ukraine

Site Reference ID/Investigator# 31690, Kharkov 61022, Ukraine

Site Reference ID/Investigator# 31679, Kiev 01601, Ukraine

Site Reference ID/Investigator# 31680, Kiev 01601, Ukraine

Site Reference ID/Investigator# 31682, Kiev 03151, Ukraine

Site Reference ID/Investigator# 31683, Kiev 03151, Ukraine

Site Reference ID/Investigator# 31684, Kiev 01601, Ukraine

Site Reference ID/Investigator# 48363, Kiev 03179, Ukraine

Site Reference ID/Investigator# 48365, Kryvyi Rih 50056, Ukraine

Site Reference ID/Investigator# 48366, Lviv 79010, Ukraine

Site Reference ID/Investigator# 48367, Lviv 79010, Ukraine

Site Reference ID/Investigator# 48368, Lviv 79035, Ukraine

Site Reference ID/Investigator# 31689, Odessa 65027, Ukraine

Site Reference ID/Investigator# 31694, Simferopol 95017, Ukraine

Site Reference ID/Investigator# 43243, Uzhgorod 88000, Ukraine

Site Reference ID/Investigator# 48369, Uzhgorod 88000, Ukraine

Site Reference ID/Investigator# 48370, Uzhgorod 88000, Ukraine

Site Reference ID/Investigator# 31691, Vinnitsa 21018, Ukraine

Site Reference ID/Investigator# 31692, Zaporogzhe 69000, Ukraine

Site Reference ID/Investigator# 48371, Zhytomyr 10000, Ukraine

Additional Information

Starting date: April 2009
Last updated: February 8, 2013

Page last updated: August 23, 2015

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