A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952509
• Other study ID #: ML28747
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: November 1, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Ministerio de Salud de Guatemala (Guatemala MoH)
• Study type: Observational

Clinical Trial Summary

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• 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 according to the revised (1987) ACR criteria

• Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

• Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit

• Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use

• Patients who have received 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

• Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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

Countries where clinical trial is conducted

Costa Rica,  Dominican Republic,  Guatemala,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation		approximately 2 years	No
Secondary	Rates of dose modifications/interruptions		approximately 2 years	No
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		approximately 2 years	No
Secondary	Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6		approximately 2 years	No
Secondary	Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR		approximately 2 years	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Health Assessment Questionnaire Disability Index		approximately 2 years	No
Secondary	Visual Analogue Scale - Fatigue		approximately 2 years	No
Secondary	Visual Analogue Scale - severity of pain		approximately 2 years	No
Secondary	Visual Analogue Scale - morning stiffness		aproximately 2 years	No
Secondary	Patient Global Assessment of disease activity		approximately 2 years	No