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

Rheumatoid Arthritis Clinical Trial

Official title:

Tocilizumab (RoActemra) poST Marketing Observational Study in DMARD-IR Patients to Assess Efficacy and Safety in routiNE Clinical Practice - STONE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277328
• Other study ID #: ML25332
• Status: Terminated
• Phase: N/A
• First received: January 13, 2011
• Last updated: September 14, 2016
• Start date: May 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicine and Medical Devices Agency (NMMDA)
• Study type: Observational

Clinical Trial Summary

This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients >/=18 years of age

• Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria:

• Hypersensitivity to RoActemra

• Active, severe infections

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

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Disease Activity Score 28 (DAS28)		11 months	No
Secondary	Proportion of patients with a change in Disease Activity Score 28 (DAS28)		5 months	No
Secondary	European League Against Rheumatism (EULAR) response rates		20 weeks	No
Secondary	Proportion of patients with disease remission		20 weeks	No
Secondary	Proportion of patients with low disease activity		20 weeks	No
Secondary	Incidence of adverse events		11 months	No