EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries (EviraEAST)
|ClinicalTrials.gov Identifier: NCT01078402|
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : February 7, 2013
Last Update Posted : February 12, 2013
|Condition or disease|
|Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA Rheumatoid Arthritis (RA|
|Study Type :||Observational|
|Actual Enrollment :||809 participants|
|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 Start Date :||April 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Single patients group: RA, PsA and AS
Single patients group with: Active Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS)
- 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 ]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.
- 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 [ Time Frame: Baseline, 3 months ]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.
- Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy [ Time Frame: Baseline, 4, 7 and 13 months ]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.
- Participant Acceptability of Self-injection at Month 13 (End of Study) [ Time Frame: 13 months ]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.
- Compliance With the Humira Administration Schedule at Month 13 (End of Study) [ Time Frame: Month 13 ]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.
- Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy [ Time Frame: From first treatment until study discontinuation, up to 13 months. ]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.
- Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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. ]Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078402
|Study Director:||Maja Hojnik||AbbVie|