An Observational Study of RoActemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Non-Biological DMARDs

Rheumatoid Arthritis Clinical Trial

Official title:

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617005
• Other study ID #: ML25699
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: July 1, 2016
• Start date: May 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Montenegro: Agency for Drugs and Medical Devices - CALIMS
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the safety and efficacy of RoActemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis and an inadequate response to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Data will be collected from each eligible patient initiating RoActemra treatment over 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >18 years of age

• Moderate to severe active rheumatoid arthritis (EULAR criteria)

• Inadequate response to DMARDs

• Initiating treatment with RoActemra according to summary of product characteristics (SPC)

Exclusion Criteria:

• Pregnant or lactating females

• Rheumatic autoimmune disease other than rheumatoid arthritis

• Prior history or current inflammatory joint disease other than rheumatoid arthritis

• Previous treatment with any biological drug used in the treatment of rheumatoid arthritis

• Previous treatment with RoActemra/Actemra

• Any contraindication to treatment with 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

Montenegro, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3.5 years	No
Secondary	Percentage of patients with good or moderate response according to EULAR criteria		approximately 3.5 years	No
Secondary	Number of treatment discontinuations due to lack of efficacy		approximately 3.5 years	No