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
The primary objective of this post-marketing observational study (PMOS) is to evaluate the
clinical outcome of HUMIRA® in routine clinical use in rheumatologic patients in different
Eastern European countries.
The secondary objectives of this PMOS are to evaluate in rheumatologic patients being
routinely treated with Humira in Eastern Europe:
- Tolerability of treatment with HUMIRA®
- Duration of treatment with HUMIRA ®
- Change in Quality of Life (HAQ-DI)
- Patient acceptability of self-injection and compliance with therapy
- Patient characteristics (demographic, social, disease type, severity and duration)
- The routine rheumatologic practices (previous and current disease specific treatment)
Each patient will be observed during his/her HUMIRA® treatment for a period of max. 13
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.
The tuberculosis (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.
Study Conduct This PMOS will be conducted in a prospective, single-arm, multicountry,
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 TB screening and
prophylaxis, if indicated), which defines the survey for each patient.
For indicative purposes, follow-up of patients should enable 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 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.
For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4", "V5", "V6",
"V7", although numbers and dates will depend only on the decision of the physician:
- V1: Screening visit (followed by TB prophylaxis, if indicated)
- V2: Baseline and introduction of HUMIRA® therapy
- V3: 1 month after introduction of HUMIRA® therapy
- V4: 3 months after previous visit
- V5: 3 months after previous visit
- V6: 3 months after previous visit
- V7: 3 months after previous visit Failure to meet these suggested dates will not
constitute a breach of the protocol.
Time Perspective: Prospective
Patients with RA: The primary end point will be the proportion of patients with a Disease Activity Score (DAS) 28 decrease by 1.2 or more after 3 months of HUMIRA® therapy relative to baseline (DAS 28 decrease ≥ 1.2)
Maja Hojnik, MD, PhD
Romania: Ethics Committee