Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
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.
Observational
Time Perspective: Prospective
Bone densitometry (DEXA),
Day 0, Month 12. Month 24
No
Ladislav Senolt, MD
Principal Investigator
Rheumatological Institute, Prague, Czech republic
Romania: Ethics Committee
P10-733
NCT01078155
March 2009
July 2014
Name | Location |
---|