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

Ankylosing Spondylitis (AS) Clinical Trial

— EviraEAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078402
• Other study ID #: P10-919
• Status: Completed
• Phase: N/A
• First received: February 27, 2010
• Last updated: February 8, 2013
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlRomania: Ethics CommitteeHungary: Research Ethics Medical CommitteeSlovak Republic: Ethics CommitteeUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Croatia	Site Reference ID/Investigator# 43283	Opatija
Croatia	Site Reference ID/Investigator# 43282	Osijek
Croatia	Site Reference ID/Investigator# 43286	Rijeka
Croatia	Site Reference ID/Investigator# 43284	Split
Croatia	Site Reference ID/Investigator# 22405	Zagreb
Croatia	Site Reference ID/Investigator# 43285	Zagreb
Hungary	Site Reference ID/Investigator# 32633	Budapest
Hungary	Site Reference ID/Investigator# 32634	Budapest
Hungary	Site Reference ID/Investigator# 32635	Budapest
Hungary	Site Reference ID/Investigator# 32636	Budapest
Hungary	Site Reference ID/Investigator# 32638	Budapest
Hungary	Site Reference ID/Investigator# 32639	Budapest
Hungary	Site Reference ID/Investigator# 32640	Budapest
Hungary	Site Reference ID/Investigator# 32641	Budapest
Hungary	Site Reference ID/Investigator# 32642	Budapest
Hungary	Site Reference ID/Investigator# 32676	Budapest
Hungary	Site Reference ID/Investigator# 32677	Budapest
Hungary	Site Reference ID/Investigator# 32679	Budapest
Hungary	Site Reference ID/Investigator# 32680	Budapest
Hungary	Site Reference ID/Investigator# 32681	Budapest
Hungary	Site Reference ID/Investigator# 32682	Budapest
Hungary	Site Reference ID/Investigator# 32685	Budapest
Hungary	Site Reference ID/Investigator# 32686	Budapest
Hungary	Site Reference ID/Investigator# 32687	Budapest
Hungary	Site Reference ID/Investigator# 32688	Budapest
Hungary	Site Reference ID/Investigator# 32689	Budapest
Hungary	Site Reference ID/Investigator# 32691	Budapest
Hungary	Site Reference ID/Investigator# 32692	Budapest
Hungary	Site Reference ID/Investigator# 32693	Budapest
Hungary	Site Reference ID/Investigator# 32694	Budapest
Hungary	Site Reference ID/Investigator# 32695	Budapest
Hungary	Site Reference ID/Investigator# 32591	Debrecen
Hungary	Site Reference ID/Investigator# 32592	Debrecen
Hungary	Site Reference ID/Investigator# 32612	Debrecen
Hungary	Site Reference ID/Investigator# 32613	Debrecen
Hungary	Site Reference ID/Investigator# 32614	Debrecen
Hungary	Site Reference ID/Investigator# 32615	Debrecen
Hungary	Site Reference ID/Investigator# 32616	Debrecen
Hungary	Site Reference ID/Investigator# 32584	Esztergom
Hungary	Site Reference ID/Investigator# 32585	Esztergom
Hungary	Site Reference ID/Investigator# 32629	Gyor
Hungary	Site Reference ID/Investigator# 32630	Gyor
Hungary	Site Reference ID/Investigator# 32696	Gyula
Hungary	Site Reference ID/Investigator# 32697	Gyula
Hungary	Site Reference ID/Investigator# 32698	Gyula
Hungary	Site Reference ID/Investigator# 32699	Gyula
Hungary	Site Reference ID/Investigator# 32700	Gyula
Hungary	Site Reference ID/Investigator# 32701	Gyula
Hungary	Site Reference ID/Investigator# 32702	Gyula
Hungary	Site Reference ID/Investigator# 32703	Gyula
Hungary	Site Reference ID/Investigator# 32566	Heviz
Hungary	Site Reference ID/Investigator# 32580	Kecskemet
Hungary	Site Reference ID/Investigator# 32581	Kecskemet
Hungary	Site Reference ID/Investigator# 32582	Kistarcsa
Hungary	Site Reference ID/Investigator# 32583	Kistarcsa
Hungary	Site Reference ID/Investigator# 32624	Miskolc
Hungary	Site Reference ID/Investigator# 32625	Miskolc
Hungary	Site Reference ID/Investigator# 32626	Miskolc
Hungary	Site Reference ID/Investigator# 32586	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 32588	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 32589	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 32590	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 32704	Pecs
Hungary	Site Reference ID/Investigator# 32705	Pecs
Hungary	Site Reference ID/Investigator# 32709	Pecs
Hungary	Site Reference ID/Investigator# 32617	Szeged
Hungary	Site Reference ID/Investigator# 32618	Szeged
Hungary	Site Reference ID/Investigator# 32619	Szeged
Hungary	Site Reference ID/Investigator# 32627	Szekesfehervar
Hungary	Site Reference ID/Investigator# 32628	Szekesfehervar
Hungary	Site Reference ID/Investigator# 32594	Szolnok
Hungary	Site Reference ID/Investigator# 32595	Szolnok
Hungary	Site Reference ID/Investigator# 32620	Szombathely
Hungary	Site Reference ID/Investigator# 32622	Szombathely
Hungary	Site Reference ID/Investigator# 32711	Veszprem
Hungary	Site Reference ID/Investigator# 32712	Veszprem
Hungary	Site Reference ID/Investigator# 32713	Veszprem
Israel	Site Reference ID/Investigator# 32079	Ashkelon
Israel	Site Reference ID/Investigator# 32080	Haifa
Israel	Site Reference ID/Investigator# 32082	Haifa
Israel	Site Reference ID/Investigator# 32081	Tel Hashomer
Israel	Site Reference ID/Investigator# 65468	Tel Hashomer
Israel	Site Reference ID/Investigator# 32078	Zrifin
Poland	Site Reference ID/Investigator# 32599	Bytom
Poland	Site Reference ID/Investigator# 32559	Krakow
Poland	Site Reference ID/Investigator# 32560	Krakow
Poland	Site Reference ID/Investigator# 43244	Krakow
Poland	Site Reference ID/Investigator# 43251	Krakow
Poland	Site Reference ID/Investigator# 43252	Krakow
Poland	Site Reference ID/Investigator# 43245	Poznan
Poland	Site Reference ID/Investigator# 43246	Poznan
Poland	Site Reference ID/Investigator# 32596	Sopot
Poland	Site Reference ID/Investigator# 32597	Sopot
Poland	Site Reference ID/Investigator# 43250	Wroclaw
Romania	Site Reference ID/Investigator# 31675	Brasov
Romania	Site Reference ID/Investigator# 31669	Bucharest
Romania	Site Reference ID/Investigator# 31670	Bucharest
Romania	Site Reference ID/Investigator# 31671	Bucharest
Romania	Site Reference ID/Investigator# 31672	Bucharest
Romania	Site Reference ID/Investigator# 31678	Bucharest
Romania	Site Reference ID/Investigator# 32090	Bucharest
Romania	Site Reference ID/Investigator# 32091	Bucharest
Romania	Site Reference ID/Investigator# 32094	Bucharest
Romania	Site Reference ID/Investigator# 32098	Bucharest
Romania	Site Reference ID/Investigator# 32099	Bucharest
Romania	Site Reference ID/Investigator# 32568	Bucharest
Romania	Site Reference ID/Investigator# 32569	Bucharest
Romania	Site Reference ID/Investigator# 32570	Bucharest
Romania	Site Reference ID/Investigator# 32571	Bucharest
Romania	Site Reference ID/Investigator# 32575	Bucharest
Romania	Site Reference ID/Investigator# 32576	Bucharest
Romania	Site Reference ID/Investigator# 32577	Bucharest
Romania	Site Reference ID/Investigator# 32578	Bucharest
Romania	Site Reference ID/Investigator# 32097	Cluj-Napoca
Romania	Site Reference ID/Investigator# 32100	Cluj-Napoca
Romania	Site Reference ID/Investigator# 32101	Constanta
Romania	Site Reference ID/Investigator# 32103	Constanta
Romania	Site Reference ID/Investigator# 31673	Craiova
Romania	Site Reference ID/Investigator# 31674	Craiova
Romania	Site Reference ID/Investigator# 19163	Iasi
Romania	Site Reference ID/Investigator# 31668	Iasi
Romania	Site Reference ID/Investigator# 32114	Iasi
Romania	Site Reference ID/Investigator# 32115	Iasi
Romania	Site Reference ID/Investigator# 32116	Iasi
Romania	Site Reference ID/Investigator# 32117	Iasi
Romania	Site Reference ID/Investigator# 32118	Iasi
Romania	Site Reference ID/Investigator# 32119	Iasi
Romania	Site Reference ID/Investigator# 32112	Piatra Neamt
Romania	Site Reference ID/Investigator# 32572	Ploiesti
Romania	Site Reference ID/Investigator# 32573	Ploiesti
Romania	Site Reference ID/Investigator# 32574	Ploiesti
Romania	Site Reference ID/Investigator# 31676	Sf. Gheorghe jud. Covasna
Romania	Site Reference ID/Investigator# 32104	Targu Mures
Romania	Site Reference ID/Investigator# 32105	Targu Mures
Romania	Site Reference ID/Investigator# 32108	Timisoara
Romania	Site Reference ID/Investigator# 32113	Timisoara
Slovakia	Site Reference ID/Investigator# 19164	Banska Bystrica
Slovakia	Site Reference ID/Investigator# 43262	Bratislava
Slovakia	Site Reference ID/Investigator# 43263	Kosice
Ukraine	Site Reference ID/Investigator# 43242	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 48364	Dnipropetrovsk
Ukraine	Site Reference ID/Investigator# 31685	Donetsk
Ukraine	Site Reference ID/Investigator# 31693	Donetsk
Ukraine	Site Reference ID/Investigator# 31686	Kharkov
Ukraine	Site Reference ID/Investigator# 31690	Kharkov
Ukraine	Site Reference ID/Investigator# 31679	Kiev
Ukraine	Site Reference ID/Investigator# 31680	Kiev
Ukraine	Site Reference ID/Investigator# 31682	Kiev
Ukraine	Site Reference ID/Investigator# 31683	Kiev
Ukraine	Site Reference ID/Investigator# 31684	Kiev
Ukraine	Site Reference ID/Investigator# 48363	Kiev
Ukraine	Site Reference ID/Investigator# 48365	Kryvyi Rih
Ukraine	Site Reference ID/Investigator# 48366	Lviv
Ukraine	Site Reference ID/Investigator# 48367	Lviv
Ukraine	Site Reference ID/Investigator# 48368	Lviv
Ukraine	Site Reference ID/Investigator# 31689	Odessa
Ukraine	Site Reference ID/Investigator# 31694	Simferopol
Ukraine	Site Reference ID/Investigator# 43243	Uzhgorod
Ukraine	Site Reference ID/Investigator# 48369	Uzhgorod
Ukraine	Site Reference ID/Investigator# 48370	Uzhgorod
Ukraine	Site Reference ID/Investigator# 31691	Vinnitsa
Ukraine	Site Reference ID/Investigator# 31692	Zaporogzhe
Ukraine	Site Reference ID/Investigator# 48371	Zhytomyr

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Croatia,  Hungary,  Israel,  Poland,  Romania,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome (Disease Activity Score [DAS28] Decrease =1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA	DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.	Baseline, 3 months	No
Primary	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	BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.	Baseline, 3 months	No
Secondary	Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy	HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.	Baseline, 4, 7 and 13 months	No
Secondary	Participant Acceptability of Self-injection at Month 13 (End of Study)	Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.	13 months	No
Secondary	Compliance With the Humira Administration Schedule at Month 13 (End of Study)	Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.	Month 13	No
Secondary	Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy	Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.	From first treatment until study discontinuation, up to 13 months.	Yes
Secondary	Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.	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.	Yes

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