Clinical trial NCT01564901: An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
Official title: A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids

Brief summary: This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.


Eligibility criteria: Inclusion Criteria:

* Adults patients, over 18 years of age
* Patients with moderate to severe rheumatoid arthritis (RA)
* Patients on a stable dose of prednisone or equivalent (\>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria:

* Patients previously treated with RoActemra/Actemra
* Any contraindication to RoActemra/Actemra

Primary outcomes:
measure: Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
timeFrame: Week 36
Secondary outcomes:
measure: Change from baseline in glucocorticoid dose
timeFrame: Week 36
measure: Change from baseline in corticosteroid dose
timeFrame: Week 36
measure: Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
timeFrame: Week 36
measure: Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
timeFrame: Week 36
measure: Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
timeFrame: Week 36
measure: Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day
timeFrame: Week 36
measure: Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day
timeFrame: Week 36
measure: Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction
timeFrame: Week 36
measure: Percentage change in Disease Activity Score 28 (DAS28)
timeFrame: Week 36
measure: Percentage change in Simplified Disease Activity Index (SDAI) score
timeFrame: Week 36
measure: Safety: Incidence of adverse events
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Elche
country: Spain
state: Alicante
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Ponferrada
country: Spain
state: Leon
city: Alzira
country: Spain
state: Valencia
city: Bilbao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Huesca
country: Spain
city: Leon
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: