Effectiveness of Adalimumab on Extraarticular Manifestation in Patients With Active Rheumatoid Arthritis

2014-07-23 21:09:57 | BioPortfolio


Tumor Necrosis Factor blocking therapy with adalimumab can modulate bone turnover markers as well as bone mineral density in cohort of Czech patients with active Rheumatoid Arthritis. The endpoint is an observation of prevention of generalized bone loss in patients with active Rheumatoid Arthritis treated with Humira in pragmatic prescribing situations. This Post Marketing Observational Study will be conducted in a prospective, double-arm, single-country, multicenter format. The investigational sites will be centers with experience in the treatment of Rheumatoid Arthritis patients and the anti Tumor Necrosis factor alfa therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment. Since this will be a Post Marketing Observational Study, Humira® will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as the local guidelines.


Follow-up of patients enables 4 patient visits during this period. Screening/Inclusion Visit is performed when the decision to start anti Tumor Necrosis Factor-alfa therapy is made. Inclusion of patient will succeed at day 0 (Screening/Inclusion Visit). The Second Visit follows 3 month after the Screening/Inclusion Visit. The Third and Fourth Visits are taking place at the month 12 and month 24 of the patient treatment. For these reasons, the most likely visits are defined as "S/V", "V1", "V2", "V3". The end point is an evidence of prevention of generalized bone loss in patients with active Rheumatoid Arthritis treated with Humira® in pragmatic prescribing situations.

Study Design

Time Perspective: Prospective


Active Rheumatoid Arthritis


Site Reference ID/Investigator# 32407
Czech Republic





Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:57-0400

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