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

NCT01078402 | Completed Results

• 1 other identifier: P10-919
• Study Type: observational
• Target: 809
• Locations: 7 countries
• Sites: 163

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

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

  Baseline, 4, 7 and 13 months

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

  13 months

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

  Month 13

• Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy

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

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

  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.

Study Arms (1)

Single patients group: RA, PsA and AS

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (163)

Site Reference ID/Investigator# 43283

Opatija, 51410, Croatia

Location

Site Reference ID/Investigator# 43282

Osijek, 31000, Croatia

Location

Site Reference ID/Investigator# 43286

Rijeka, 51 000, Croatia

Location

Site Reference ID/Investigator# 43284

Split, 21000, Croatia

Location

Site Reference ID/Investigator# 22405

Zagreb, 10000, Croatia

Location

Site Reference ID/Investigator# 43285

Zagreb, 10000, Croatia

Location

Site Reference ID/Investigator# 32641

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32642

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32676

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32677

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32679

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32680

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32681

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32682

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32685

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32686

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32687

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32688

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32689

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32691

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32692

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32693

Budapest, 1023, Hungary

Location

Site Reference ID/Investigator# 32633

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32634

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32635

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32636

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32638

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32639

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32640

Budapest, 1027, Hungary

Location

Site Reference ID/Investigator# 32694

Budapest, 1062, Hungary

Location

Site Reference ID/Investigator# 32695

Budapest, 1062, Hungary

Location

Site Reference ID/Investigator# 32612

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 32613

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 32614

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 32615

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 32616

Debrecen, 4032, Hungary

Location

Site Reference ID/Investigator# 32591

Debrecen, 4043, Hungary

Location

Site Reference ID/Investigator# 32592

Debrecen, 4043, Hungary

Location

Site Reference ID/Investigator# 32584

Esztergom, 2500, Hungary

Location

Site Reference ID/Investigator# 32585

Esztergom, 2500, Hungary

Location

Site Reference ID/Investigator# 32629

Győr, 9023, Hungary

Location

Site Reference ID/Investigator# 32630

Győr, 9023, Hungary

Location

Site Reference ID/Investigator# 32696

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32697

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32698

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32699

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32700

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32701

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32702

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32703

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 32566

Hévíz, 8381, Hungary

Location

Site Reference ID/Investigator# 32580

Kecskemét, 6000, Hungary

Location

Site Reference ID/Investigator# 32581

Kecskemét, 6000, Hungary

Location

Site Reference ID/Investigator# 32582

Kistarcsa, 2143, Hungary

Location

Site Reference ID/Investigator# 32583

Kistarcsa, 2143, Hungary

Location

Site Reference ID/Investigator# 32624

Miskolc, 3529, Hungary

Location

Site Reference ID/Investigator# 32625

Miskolc, 3529, Hungary

Location

Site Reference ID/Investigator# 32626

Miskolc, 3529, Hungary

Location

Site Reference ID/Investigator# 32586

Nyíregyháza, 4400, Hungary

Location

Site Reference ID/Investigator# 32588

Nyíregyháza, 4400, Hungary

Location

Site Reference ID/Investigator# 32589

Nyíregyháza, 4400, Hungary

Location

Site Reference ID/Investigator# 32590

Nyíregyháza, 4400, Hungary

Location

Site Reference ID/Investigator# 32704

Pécs, 7643, Hungary

Location

Site Reference ID/Investigator# 32705

Pécs, 7643, Hungary

Location

Site Reference ID/Investigator# 32709

Pécs, 7643, Hungary

Location

Site Reference ID/Investigator# 32617

Szeged, 6722, Hungary

Location

Site Reference ID/Investigator# 32618

Szeged, 6722, Hungary

Location

Site Reference ID/Investigator# 32619

Szeged, 6722, Hungary

Location

Site Reference ID/Investigator# 32627

Székesfehérvár, 8000, Hungary

Location

Site Reference ID/Investigator# 32628

Székesfehérvár, 8000, Hungary

Location

Site Reference ID/Investigator# 32594

Szolnok, 5000, Hungary

Location

Site Reference ID/Investigator# 32595

Szolnok, 5000, Hungary

Location

Site Reference ID/Investigator# 32620

Szombathely, 9702, Hungary

Location

Site Reference ID/Investigator# 32622

Szombathely, 9702, Hungary

Location

Site Reference ID/Investigator# 32711

Veszprém, 8200, Hungary

Location

Site Reference ID/Investigator# 32712

Veszprém, 8200, Hungary

Location

Site Reference ID/Investigator# 32713

Veszprém, 8200, Hungary

Location

Site Reference ID/Investigator# 32079

Ashkelon, 78287, Israel

Location

Site Reference ID/Investigator# 32082

Haifa, 31096, Israel

Location

Site Reference ID/Investigator# 32080

Haifa, 34362, Israel

Location

Site Reference ID/Investigator# 32081

Tel Litwinsky, 52621, Israel

Location

Site Reference ID/Investigator# 65468

Tel Litwinsky, 52621, Israel

Location

Site Reference ID/Investigator# 32078

Zrifin, 70300, Israel

Location

Site Reference ID/Investigator# 32599

Bytom, 41-900, Poland

Location

Site Reference ID/Investigator# 43251

Krakow, 30-119, Poland

Location

Site Reference ID/Investigator# 32559

Krakow, 31-121, Poland

Location

Site Reference ID/Investigator# 32560

Krakow, 31-121, Poland

Location

Site Reference ID/Investigator# 43244

Krakow, 31-501, Poland

Location

Site Reference ID/Investigator# 43252

Krakow, 31-501, Poland

Location

Site Reference ID/Investigator# 43245

Poznan, 61-545, Poland

Location

Site Reference ID/Investigator# 43246

Poznan, 61-545, Poland

Location

Site Reference ID/Investigator# 32596

Sopot, 81-759, Poland

Location

Site Reference ID/Investigator# 32597

Sopot, 81-759, Poland

Location

Site Reference ID/Investigator# 43250

Wroclaw, 53-114, Poland

Location

Site Reference ID/Investigator# 31675

Brasov, 500097, Romania

Location

Site Reference ID/Investigator# 31678

Bucharest, 010195, Romania

Location

Site Reference ID/Investigator# 32568

Bucharest, 011172, Romania

Location

Site Reference ID/Investigator# 32569

Bucharest, 011172, Romania

Location

Site Reference ID/Investigator# 32570

Bucharest, 011172, Romania

Location

Site Reference ID/Investigator# 32571

Bucharest, 011172, Romania

Location

Site Reference ID/Investigator# 32098

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 32099

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 32575

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 32576

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 32577

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 32578

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 31669

Bucharest, 020983, Romania

Location

Site Reference ID/Investigator# 31670

Bucharest, 020983, Romania

Location

Site Reference ID/Investigator# 31671

Bucharest, 020983, Romania

Location

Site Reference ID/Investigator# 31672

Bucharest, 020983, Romania

Location

Site Reference ID/Investigator# 32094

Bucharest, 040101, Romania

Location

Site Reference ID/Investigator# 32090

Bucharest, 20125, Romania

Location

Site Reference ID/Investigator# 32091

Bucharest, 20125, Romania

Location

Site Reference ID/Investigator# 32100

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 32097

Cluj-Napoca, 400132, Romania

Location

Site Reference ID/Investigator# 32101

Constanța, 900709, Romania

Location

Site Reference ID/Investigator# 32103

Constanța, 900709, Romania

Location

Site Reference ID/Investigator# 31673

Craiova, 200374, Romania

Location

Site Reference ID/Investigator# 31674

Craiova, 200374, Romania

Location

Site Reference ID/Investigator# 19163

Iași, 700106, Romania

Location

Site Reference ID/Investigator# 31668

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32114

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32115

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32116

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32117

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32118

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32119

Iași, 700661, Romania

Location

Site Reference ID/Investigator# 32112

Piatra Neamţ, 610017, Romania

Location

Site Reference ID/Investigator# 32572

Ploieşti, 100337, Romania

Location

Site Reference ID/Investigator# 32573

Ploieşti, 100337, Romania

Location

Site Reference ID/Investigator# 32574

Ploieşti, 100337, Romania

Location

Site Reference ID/Investigator# 31676

Sf. Gheorghe Jud. Covasna, 520064, Romania

Location

Site Reference ID/Investigator# 32104

Târgu Mureş, 540136, Romania

Location

Site Reference ID/Investigator# 32105

Târgu Mureş, 540136, Romania

Location

Site Reference ID/Investigator# 32108

Timișoara, 300020, Romania

Location

Site Reference ID/Investigator# 32113

Timișoara, 300150, Romania

Location

Site Reference ID/Investigator# 19164

Banská Bystrica, 974 05, Slovakia

Location

Site Reference ID/Investigator# 43262

Bratislava, 826 06, Slovakia

Location

Site Reference ID/Investigator# 43263

Košice, 041 90, Slovakia

Location

Site Reference ID/Investigator# 43242

Dnipro, 49068, Ukraine

Location

Site Reference ID/Investigator# 48364

Dnipropetrovsk, 49005, Ukraine

Location

Site Reference ID/Investigator# 31693

Donetsk, 83000, Ukraine

Location

Site Reference ID/Investigator# 31685

Donetsk, 83045, Ukraine

Location

Site Reference ID/Investigator# 31690

Kharkiv, 61022, Ukraine

Location

Site Reference ID/Investigator# 31686

Kharkiv, 61024, Ukraine

Location

Site Reference ID/Investigator# 31679

Kiev, 01601, Ukraine

Location

Site Reference ID/Investigator# 31680

Kiev, 01601, Ukraine

Location

Site Reference ID/Investigator# 31684

Kiev, 01601, Ukraine

Location

Site Reference ID/Investigator# 31682

Kiev, 03151, Ukraine

Location

Site Reference ID/Investigator# 31683

Kiev, 03151, Ukraine

Location

Site Reference ID/Investigator# 48363

Kiev, 03179, Ukraine

Location

Site Reference ID/Investigator# 48365

Kryvyi Rih, 50056, Ukraine

Location

Site Reference ID/Investigator# 48366

Lviv, 79010, Ukraine

Location

Site Reference ID/Investigator# 48367

Lviv, 79010, Ukraine

Location

Site Reference ID/Investigator# 48368

Lviv, 79035, Ukraine

Location

Site Reference ID/Investigator# 31689

Odesa, 65027, Ukraine

Location

Site Reference ID/Investigator# 31694

Simferopol, 95017, Ukraine

Location

Site Reference ID/Investigator# 43243

Uzhhorod, 88000, Ukraine

Location

Site Reference ID/Investigator# 48369

Uzhhorod, 88000, Ukraine

Location

Site Reference ID/Investigator# 48370

Uzhhorod, 88000, Ukraine

Location

Site Reference ID/Investigator# 31691

Vinnitsa, 21018, Ukraine

Location

Site Reference ID/Investigator# 31692

Zaporogzhe, 69000, Ukraine

Location

Site Reference ID/Investigator# 48371

Zhytomyr, 10000, Ukraine

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic; Salivary Gland Adenoma, Pleomorphic; Arthritis, Rheumatoid; Patient Compliance

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Maja Hojnik

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2010
• First Posted: March 2, 2010
• Study Start: April 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 12, 2013
• Results First Posted: February 7, 2013

Record last verified: 2013-02

Locations

RO (42); CR (6); HU (71); IL (6); UA (24); PL (11); SL (3)