An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337388
• Other study ID #: ML25492
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: November 1, 2016
• Start date: August 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Observational

Clinical Trial Summary

This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, > 18 years of age

• Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria

• Treatment with RoActemra/Actemra

Exclusion Criteria:

• Participation in interventional clinical studies

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

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity score (DAS 28)		12 months	No
Primary	Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice		36 months	No
Secondary	Safety: Incidence of adverse events		36 months	No
Secondary	Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire		12 months	No
Secondary	Rate of patients achieving remission (DAS <2.6)		36 months	No
Secondary	Change in blood lipids		12 months	No
Secondary	Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate		36 months	No