The purpose of this project is to evaluate the efficacy of Tocilizumab (TCZ) given as monotherapy in patients with active rheumatoid arthritis (RA) according to EULAR response at 24 weeks after treatment initiation. The study design is an intervention study, uncontrolled, multicenter, prospective, 32-weeks, two cohorts of patients with poor compliance or with any contraindication or intolerance to methotrexate. One cohort naive to previous biological therapy and the other one treated previously with a biological treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.
Hospital Universitario Araba (Sede Txagorritxu)
Vitoria-Gasteiz, Alava, Spain
ACTIVE_NOT_RECRUITINGHospital del la Agencia Valenciana de Salud Vega Baja
Orihuela, Alicante, Spain
RECRUITINGHospital Can Misses
Ibiza Town, Balearic Islands, Spain
RECRUITINGHospital Universitari Son Espases
Mallorca, Balearic Islands, Spain
ACTIVE_NOT_RECRUITINGHospital Universitari Vall d´Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
ACTIVE_NOT_RECRUITINGHospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
RECRUITINGHospital San Cecilio
Granada, Granada, Spain
RECRUITING...and 10 more locations
Percentage of patients achieving good or moderate European League Against Rheumatism (EULAR) response.
To evaluate the efficacy of Tocilizumab monotherapy administered in patients with active rheumatoid arthritis, in terms of percentage of patients achieving good or moderate European League Against Rheumatism (EULAR) response. To be classified as a good response, patients must have a clinically significant change (\> 1.2) in DAS28 index as well as achieving low disease activity. Moderate answer assumes DAS28 index decreases between 0.6 and 1,2, long as it reaches low or moderate disease activity (DAS28 ≤ 5.1), or clinically significant (\> 1.2) in the DAS28 in patients with a moderate or high activity (DAS28\> 3.2) is achieved.
Time frame: At 24 weeks of treatment.
Changes in the mean of DAS28 index.
To evaluate the efficacy of Tocilizumab monotherapy administered in patients with active rheumatoid arthritis, in terms of Disease Activity Score 28 (DAS28) change by the response EULAR criteria.
Time frame: Between baseline and week 24.
Changes in the mean of Simplex Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI).
To evaluate the activity of rheumatoid arthritis by the Simplex Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI) using the mean change in these index.
Time frame: At 24 weeks of treatment.
Percentage of patients complying American College of Rheumatology (ACR) criteria (ACR20, ACR50 and ACR70).
To evaluate the efficacy by the American College of Rheumatology (ACR) criteria.
Time frame: At 24 weeks of treatment
Changes in the mean of DAS28 index into several subgroups.
To evaluate the efficacy in patients with active rheumatoid arthritis treated with Tocilizumab monotherapy by the change in DAS28 index between baseline and week 24 in the following subgroups: Baseline DAS28: greater than 3.2 and less than 5.1 Baseline DAS28: greater than or equal to 5.1 Cohort A: Patients who have never been treated with biological therapy. Cohort B: Patients who have been previously treated with biological therapy.
Time frame: between baseline and week 24
Percentage of patients with a DAS28 index less than or equal to 3.2
Time frame: At week 24 of treatment.
Number of non-serious, serious or unexpected adverse events.
To evaluate the safety of Tocilizumab monotherapy during the study period.
Time frame: At the end of study (32 weeks).
Changes in the mean of Health-Related Quality of Life (HRQOL) index into several subgroups.
To evaluate the Health-Related Quality of Life (HRQOL) of patients with rheumatoid arthritis treated with Tocilizumab monotherapy in the following subgroups: Baseline DAS28: greater than 3.2 and less than 5.1 Baseline DAS28: greater than or equal to 5.1 Cohort A: Patients who have never been treated with biological therapy. Cohort B: Patients who have been previously treated with biological therapy.
Time frame: between baseline and week 24.
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