An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338545
• Other study ID #: ML25264
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: November 1, 2016
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• 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 (RA) of at least 6 months duration

• Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment

• Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications

Exclusion Criteria:

• History of autoimmune disease or of any joint inflammatory disease other than RA

• Pregnant or lactating women

• Patients who have started RoActemra treatment in a clinical trial or for compassionate use

• Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)

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

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons		12 months	No
Secondary	Safety: Incidence of adverse events		12 months	No
Secondary	Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)		12 months	No
Secondary	Response rate according to EULAR (European League Against Rheumatism) criteria		12 months	No
Secondary	Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)		12 months	No
Secondary	Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors		12 months	No
Secondary	Effect on DMARD tolerance/dosage in combination therapy		12 months	No
Secondary	Dosages used in clinical practice		12 months	No