Clareo Health | Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie (prior sponsor, Abbott)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.
You may not be if
Patients who have had a history of TNF blocking or rituximab therapy.
Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
Pregnant females and/or females without adequate method of contraception.
Patients who didn't receive prior DMARD therapy.
Patients participating in another study or clinical trial.
Patients with severe osteoporosis (T-score \[number that indicates whether or not bone loss has occurred\] of ≤ -2.5 and/or prior vertebral fracture/s).
Patients with a history of total hip replacement of both extremities.
Patients who currently receive and/or received bone metabolism modulating agents including Selective Estrogen Receptor Modulators (SERMs), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappaB ligand (RANKL) therapy.
