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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01338545
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons	12 months

Secondary Outcome Measures

Name	Time	Method
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors	12 months
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)	12 months
Response rate according to EULAR (European League Against Rheumatism) criteria	12 months
Safety: Incidence of adverse events	12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)	12 months
Effect on DMARD tolerance/dosage in combination therapy	12 months
Dosages used in clinical practice	12 months