Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

• Bone densitometry (DEXA), [ Time Frame: Day 0, Month 12. Month 24 ] [ Designated as safety issue: No ]
• Bone turnover markers (osteocalcin - OC, C-terminal type I procollagen peptide - CICP, and C-telopeptide of type I collagen - CTX-I) [ Time Frame: Day 0, Month 3, Month 12 ] [ Designated as safety issue: No ]
• Morning stiffness [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
• Tender Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]

• Bone densitometry (DEXA), [ Time Frame: Day 0, Month 12 ] [ Designated as safety issue: No ]
• Bone turnover markers (osteocalcin - OC, C-terminal type I procollagen peptide - CICP, and C-telopeptide of type I collagen - CTX-I) [ Time Frame: Day 0, Month 3, Month 24 ] [ Designated as safety issue: No ]
• Morning stiffness [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
• Tender Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]

• Swollen Joint Count [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
• DAS 28 (Assessment of Disease Activity) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
• VAS (Visual Analogue Scale) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]
• ESR (Erythrocytes Sedimentation Rate) [ Time Frame: Day 0,Month 3, Month 12, Month 24 ] [ Designated as safety issue: No ]

Tumor Necrosis Factor blocking therapy with adalimumab can modulate bone turnover markers as well as bone mineral density in cohort of patients with active Rheumatoid Arthritis. The endpoint 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 TNF-a 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.

Patients with active rheumatoid arthritis

• Rheumatoid Arthritis
• Osteoporosis

Inclusion Criteria:

• Patients with active early and long-standing RA (rheumatoid arthritis) according to ACR (American College of Rheumatology) 1987 revised criteria.
• Patients with high disease activity {DAS28 (Assessment of Disease Activity) >5.1 according to the Czech Rheumatological Society criteria}.

• Patients must fulfill national guidelines for use of anti-Tumor Necrosis Factor:

  • inadequate clinical response to at least one DMARD (methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to at least 5 mg prednisolone per day),
  • Chest X-ray, PPD-skin test, Quantiferon/TB Gold test if available negative for tuberculosis).

Exclusion Criteria:

• Patients who have had a history of Tumor Necrosis Factor blocking or rituximab therapy.
• Patients who are being treated or will be treated with drug at risk of interaction with Humira ®.
• Pregnant female and/or female without adequate method of contraception. Patients who didn't receive prior DMARD (Disease-modifying antirheumatic drugs) 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 SERMs (Selective Estrogen Receptor Modulators), bisphosphonates, parathyroid hormone or anti-RANKL (receptor activator of nuclear factor-kappaB ligand) therapy.
• Subjects who are not eligible for TNF - blocking therapy according to the Czech National Registry ( ATTRA).