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Ankylosing Spondylitis (AS)EviraEASTNCT01078402

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

An observational study of Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA, run by AbbVie (prior sponsor, Abbott) at 163 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
809 participants
Where
163 sitesin 7 countries
Study dates
Apr 2009to Nov 2011
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

163 sites in 7 countries.

163 sites in 7 countries

Hungary71 sites

  • Site Reference ID/Investigator# 32641

    Budapest, 1023

  • Site Reference ID/Investigator# 32642

    Budapest, 1023

  • Site Reference ID/Investigator# 32676

    Budapest, 1023

  • Site Reference ID/Investigator# 32677

    Budapest, 1023

  • Site Reference ID/Investigator# 32679

    Budapest, 1023

  • Site Reference ID/Investigator# 32680

    Budapest, 1023

  • Site Reference ID/Investigator# 32681

    Budapest, 1023

  • Site Reference ID/Investigator# 32682

    Budapest, 1023

  • Site Reference ID/Investigator# 32685

    Budapest, 1023

  • Site Reference ID/Investigator# 32686

    Budapest, 1023

  • Site Reference ID/Investigator# 32687

    Budapest, 1023

  • Site Reference ID/Investigator# 32688

    Budapest, 1023

  • Site Reference ID/Investigator# 32689

    Budapest, 1023

  • Site Reference ID/Investigator# 32691

    Budapest, 1023

  • Site Reference ID/Investigator# 32692

    Budapest, 1023

  • Site Reference ID/Investigator# 32693

    Budapest, 1023

  • Site Reference ID/Investigator# 32633

    Budapest, 1027

  • Site Reference ID/Investigator# 32634

    Budapest, 1027

  • Site Reference ID/Investigator# 32635

    Budapest, 1027

  • Site Reference ID/Investigator# 32636

    Budapest, 1027

  • Site Reference ID/Investigator# 32638

    Budapest, 1027

  • Site Reference ID/Investigator# 32639

    Budapest, 1027

  • Site Reference ID/Investigator# 32640

    Budapest, 1027

  • Site Reference ID/Investigator# 32694

    Budapest, 1062

  • Site Reference ID/Investigator# 32695

    Budapest, 1062

  • Site Reference ID/Investigator# 32612

    Debrecen, 4032

  • Site Reference ID/Investigator# 32613

    Debrecen, 4032

  • Site Reference ID/Investigator# 32614

    Debrecen, 4032

  • Site Reference ID/Investigator# 32615

    Debrecen, 4032

  • Site Reference ID/Investigator# 32616

    Debrecen, 4032

  • Site Reference ID/Investigator# 32591

    Debrecen, 4043

  • Site Reference ID/Investigator# 32592

    Debrecen, 4043

  • Site Reference ID/Investigator# 32584

    Esztergom, 2500

  • Site Reference ID/Investigator# 32585

    Esztergom, 2500

  • Site Reference ID/Investigator# 32629

    Győr, 9023

  • Site Reference ID/Investigator# 32630

    Győr, 9023

  • Site Reference ID/Investigator# 32696

    Gyula, 5700

  • Site Reference ID/Investigator# 32697

    Gyula, 5700

  • Site Reference ID/Investigator# 32698

    Gyula, 5700

  • Site Reference ID/Investigator# 32699

    Gyula, 5700

  • Site Reference ID/Investigator# 32700

    Gyula, 5700

  • Site Reference ID/Investigator# 32701

    Gyula, 5700

  • Site Reference ID/Investigator# 32702

    Gyula, 5700

  • Site Reference ID/Investigator# 32703

    Gyula, 5700

  • Site Reference ID/Investigator# 32566

    Hévíz, 8381

  • Site Reference ID/Investigator# 32580

    Kecskemét, 6000

  • Site Reference ID/Investigator# 32581

    Kecskemét, 6000

  • Site Reference ID/Investigator# 32582

    Kistarcsa, 2143

  • Site Reference ID/Investigator# 32583

    Kistarcsa, 2143

  • Site Reference ID/Investigator# 32624

    Miskolc, 3529

  • Site Reference ID/Investigator# 32625

    Miskolc, 3529

  • Site Reference ID/Investigator# 32626

    Miskolc, 3529

  • Site Reference ID/Investigator# 32586

    Nyíregyháza, 4400

  • Site Reference ID/Investigator# 32588

    Nyíregyháza, 4400

  • Site Reference ID/Investigator# 32589

    Nyíregyháza, 4400

  • Site Reference ID/Investigator# 32590

    Nyíregyháza, 4400

  • Site Reference ID/Investigator# 32704

    Pécs, 7643

  • Site Reference ID/Investigator# 32705

    Pécs, 7643

  • Site Reference ID/Investigator# 32709

    Pécs, 7643

  • Site Reference ID/Investigator# 32617

    Szeged, 6722

  • Site Reference ID/Investigator# 32618

    Szeged, 6722

  • Site Reference ID/Investigator# 32619

    Szeged, 6722

  • Site Reference ID/Investigator# 32627

    Székesfehérvár, 8000

  • Site Reference ID/Investigator# 32628

    Székesfehérvár, 8000

  • Site Reference ID/Investigator# 32594

    Szolnok, 5000

  • Site Reference ID/Investigator# 32595

    Szolnok, 5000

  • Site Reference ID/Investigator# 32620

    Szombathely, 9702

  • Site Reference ID/Investigator# 32622

    Szombathely, 9702

  • Site Reference ID/Investigator# 32711

    Veszprém, 8200

  • Site Reference ID/Investigator# 32712

    Veszprém, 8200

  • Site Reference ID/Investigator# 32713

    Veszprém, 8200

Other trials in Hungary

Romania42 sites

  • Site Reference ID/Investigator# 31675

    Brasov, 500097

  • Site Reference ID/Investigator# 31678

    Bucharest, 010195

  • Site Reference ID/Investigator# 32568

    Bucharest, 011172

  • Site Reference ID/Investigator# 32569

    Bucharest, 011172

  • Site Reference ID/Investigator# 32570

    Bucharest, 011172

  • Site Reference ID/Investigator# 32571

    Bucharest, 011172

  • Site Reference ID/Investigator# 32098

    Bucharest, 020475

  • Site Reference ID/Investigator# 32099

    Bucharest, 020475

  • Site Reference ID/Investigator# 32575

    Bucharest, 020475

  • Site Reference ID/Investigator# 32576

    Bucharest, 020475

  • Site Reference ID/Investigator# 32577

    Bucharest, 020475

  • Site Reference ID/Investigator# 32578

    Bucharest, 020475

  • Site Reference ID/Investigator# 31669

    Bucharest, 020983

  • Site Reference ID/Investigator# 31670

    Bucharest, 020983

  • Site Reference ID/Investigator# 31671

    Bucharest, 020983

  • Site Reference ID/Investigator# 31672

    Bucharest, 020983

  • Site Reference ID/Investigator# 32094

    Bucharest, 040101

  • Site Reference ID/Investigator# 32090

    Bucharest, 20125

  • Site Reference ID/Investigator# 32091

    Bucharest, 20125

  • Site Reference ID/Investigator# 32100

    Cluj-Napoca, 400006

  • Site Reference ID/Investigator# 32097

    Cluj-Napoca, 400132

  • Site Reference ID/Investigator# 32101

    Constanța, 900709

  • Site Reference ID/Investigator# 32103

    Constanța, 900709

  • Site Reference ID/Investigator# 31673

    Craiova, 200374

  • Site Reference ID/Investigator# 31674

    Craiova, 200374

  • Site Reference ID/Investigator# 19163

    Iași, 700106

  • Site Reference ID/Investigator# 31668

    Iași, 700661

  • Site Reference ID/Investigator# 32114

    Iași, 700661

  • Site Reference ID/Investigator# 32115

    Iași, 700661

  • Site Reference ID/Investigator# 32116

    Iași, 700661

  • Site Reference ID/Investigator# 32117

    Iași, 700661

  • Site Reference ID/Investigator# 32118

    Iași, 700661

  • Site Reference ID/Investigator# 32119

    Iași, 700661

  • Site Reference ID/Investigator# 32112

    Piatra Neamţ, 610017

  • Site Reference ID/Investigator# 32572

    Ploieşti, 100337

  • Site Reference ID/Investigator# 32573

    Ploieşti, 100337

  • Site Reference ID/Investigator# 32574

    Ploieşti, 100337

  • Site Reference ID/Investigator# 31676

    Sf. Gheorghe Jud. Covasna, 520064

  • Site Reference ID/Investigator# 32104

    Târgu Mureş, 540136

  • Site Reference ID/Investigator# 32105

    Târgu Mureş, 540136

  • Site Reference ID/Investigator# 32108

    Timișoara, 300020

  • Site Reference ID/Investigator# 32113

    Timișoara, 300150

Other trials in Romania

Ukraine24 sites

  • Site Reference ID/Investigator# 43242

    Dnipro, 49068

  • Site Reference ID/Investigator# 48364

    Dnipropetrovsk, 49005

  • Site Reference ID/Investigator# 31693

    Donetsk, 83000

  • Site Reference ID/Investigator# 31685

    Donetsk, 83045

  • Site Reference ID/Investigator# 31690

    Kharkiv, 61022

  • Site Reference ID/Investigator# 31686

    Kharkiv, 61024

  • Site Reference ID/Investigator# 31679

    Kiev, 01601

  • Site Reference ID/Investigator# 31680

    Kiev, 01601

  • Site Reference ID/Investigator# 31684

    Kiev, 01601

  • Site Reference ID/Investigator# 31682

    Kiev, 03151

  • Site Reference ID/Investigator# 31683

    Kiev, 03151

  • Site Reference ID/Investigator# 48363

    Kiev, 03179

  • Site Reference ID/Investigator# 48365

    Kryvyi Rih, 50056

  • Site Reference ID/Investigator# 48366

    Lviv, 79010

  • Site Reference ID/Investigator# 48367

    Lviv, 79010

  • Site Reference ID/Investigator# 48368

    Lviv, 79035

  • Site Reference ID/Investigator# 31689

    Odesa, 65027

  • Site Reference ID/Investigator# 31694

    Simferopol, 95017

  • Site Reference ID/Investigator# 43243

    Uzhhorod, 88000

  • Site Reference ID/Investigator# 48369

    Uzhhorod, 88000

  • Site Reference ID/Investigator# 48370

    Uzhhorod, 88000

  • Site Reference ID/Investigator# 31691

    Vinnitsa, 21018

  • Site Reference ID/Investigator# 31692

    Zaporogzhe, 69000

  • Site Reference ID/Investigator# 48371

    Zhytomyr, 10000

Other trials in Ukraine

Poland11 sites

  • Site Reference ID/Investigator# 32599

    Bytom, 41-900

  • Site Reference ID/Investigator# 43251

    Krakow, 30-119

  • Site Reference ID/Investigator# 32559

    Krakow, 31-121

  • Site Reference ID/Investigator# 32560

    Krakow, 31-121

  • Site Reference ID/Investigator# 43244

    Krakow, 31-501

  • Site Reference ID/Investigator# 43252

    Krakow, 31-501

  • Site Reference ID/Investigator# 43245

    Poznan, 61-545

  • Site Reference ID/Investigator# 43246

    Poznan, 61-545

  • Site Reference ID/Investigator# 32596

    Sopot, 81-759

  • Site Reference ID/Investigator# 32597

    Sopot, 81-759

  • Site Reference ID/Investigator# 43250

    Wroclaw, 53-114

Other trials in Poland

Croatia6 sites

  • Site Reference ID/Investigator# 43283

    Opatija, 51410

  • Site Reference ID/Investigator# 43282

    Osijek, 31000

  • Site Reference ID/Investigator# 43286

    Rijeka, 51 000

  • Site Reference ID/Investigator# 43284

    Split, 21000

  • Site Reference ID/Investigator# 22405

    Zagreb, 10000

  • Site Reference ID/Investigator# 43285

    Zagreb, 10000

Other trials in Croatia

Israel6 sites

  • Site Reference ID/Investigator# 32079

    Ashkelon, 78287

  • Site Reference ID/Investigator# 32082

    Haifa, 31096

  • Site Reference ID/Investigator# 32080

    Haifa, 34362

  • Site Reference ID/Investigator# 32081

    Tel HaShomer, 52621

  • Site Reference ID/Investigator# 65468

    Tel HaShomer, 52621

  • Site Reference ID/Investigator# 32078

    Zrifin, 70300

Other trials in Israel

Slovakia3 sites

  • Site Reference ID/Investigator# 19164

    Banská Bystrica, 974 05

  • Site Reference ID/Investigator# 43262

    Bratislava, 826 06

  • Site Reference ID/Investigator# 43263

    Košice, 041 90

Other trials in Slovakia

About this study

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

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.

Read the 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.

Keywords
Treatment compliance and tolerability of Humira in patients, Eastern European countries, Rheumatoid Arthritis, Psoriatic Arthritis, Adalimumab, Ankylosing Spondylitis, Evaluation of clinical outcome
Medical subject headings
Spondylitis, Ankylosing, Arthritis, Psoriatic, Salivary Gland Adenoma, Pleomorphic, Arthritis, Rheumatoid, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01078402
Study groupRoleWhat they receive
Single patients group: RA, PsA and ASSingle patients group with: Active Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months

  2. 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.

    Measured: Baseline, 3 months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, 4, 7 and 13 months

  2. 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.

    Measured: 13 months

  3. 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.

    Measured: Month 13

  4. 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.

    Measured: From first treatment until study discontinuation, up to 13 months.

  5. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
809 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01078402
Sponsor's protocol ID
P10-919
Acronym
EviraEAST
Status last verified
Feb 2013
First submitted
27 Feb 2010
Last updated
12 Feb 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA, run by AbbVie (prior sponsor, Abbott) at 163 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Hungary, Romania, Ukraine, Poland, Croatia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.

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