A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770834
• Other study ID #: ML25533
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: February 28, 2018
• Start date: April 18, 2013
• Est. completion date: January 25, 2017

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 21 years of age

• Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)

• Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)

• Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

• Pregnant or lactating women

• Contra-indication to RoActemra/Actemra treatment according to the local labelling

• Previous treatment with tocilizumab

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• Women of childbearing potential not using effective methods of contraception as defined by protocol

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Kuwait,  Lebanon,  Qatar,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3 years
Secondary	Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)		approximately 3 years
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		approximately 3 years
Secondary	Treatment regimens: Concomitant medications		approximately 3 years