An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564901
• Other study ID #: ML27904
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: November 1, 2016
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day		Week 36	No
Secondary	Change from baseline in glucocorticoid dose		Week 36	No
Secondary	Change from baseline in corticosteroid dose		Week 36	No
Secondary	Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose		Week 36	No
Secondary	Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids		Week 36	No
Secondary	Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use		Week 36	No
Secondary	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		Week 36	No
Secondary	Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day		Week 36	No
Secondary	Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction		Week 36	No
Secondary	Percentage change in Disease Activity Score 28 (DAS28)		Week 36	No
Secondary	Percentage change in Simplified Disease Activity Index (SDAI) score		Week 36	No
Secondary	Safety: Incidence of adverse events		36 weeks	No