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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384461
• Other study ID #: ML25503
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: November 1, 2016
• Start date: January 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: ETT Elnökség (Medical Research Council - Presidency)
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe rheumatoid arthritis

• RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug

• Active, severe infection or history of recurrent clinically significant infection

• Pregnancy

• Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit

• Methotrexate intolerance

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

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		12 months	No
Secondary	Efficacy: Disease Activity Score (DAS 28)		12 months	No
Secondary	Pain: Visual Analogue Scale (VAS) pain scale		12 months	No
Secondary	Physical Function: Health Assessments Questionnaire (HAQ)		12 months	No
Secondary	Incidence of patients with all-cause discontinuation of tocilizumab		12 months	No