Rheumatoid Arthritis MedDRA version: 12.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid
Conditions
Interventions
Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Colecalciferol
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type
Sponsors
AZIENDA OSPEDALIERA ORDINE MAURIZIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be female 18 years of age with a diagnosis of RA, as defined by the American College of Rheumatology (ACR; formerly, the American Rheumatism Association) 1987 [38] criteria for =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - diagnoses of any other inflammatory arthritis or a secondary non-inflammatory arthritis. - Patients with a history of tuberculosis or a chest radiograph showing active tuberculosis will be also excluded. Patients who had a history of malignancy, or severe, progressive, and/or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease will be excluded. - not previously treated wit glucocorticoid or disease modifying activity drugs - Patients who had received any biologic therapy within 6 months (or had received etanercept and/or anakinra within 3 months) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2- evaluate the role of vitamin D as immunomodulator in early RA 3- evaluate the effect of vitamin D on osteoclastogenesis in early RA;Secondary Objective: 1-explore the role of vitamin D in the pathogenesis of early RA 2-evaluate the clinical effect of vitamin D in early RA;Primary end point(s): 1- explore the role of vitamin D in the pathogenesis of RA 2- 2- evaluate the role of vitamin D as immunomodulator and antinflammatory in RA | — |
Countries
Italy
Outcome results
None listed