An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Banská Bystrica, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients, >/= 18 years of age
Moderate to severe active rheumatoid arthritis
Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion criteria

Pregnant or lactating women
Active infection
Positive for hepatitis B, hepatitis C or HIV infection
Concomitant anti-TNF drugs
Contraindications to treatment with RoActemra/Actemra

Treatment and study plan

Primary outcomes

Disease activity score (DAS28)

Time frame: 12 months

Secondary outcomes

DAS 28 (subgroup on monotherapy)

Time frame: 12 months
DAS 28 (subgroup on 4 mg/kg dose)

Time frame: 12 months
Safety: Incidence of adverse events

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

DAS Evaluation of RA Activity in Patients Treated With Tocilizumab

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 6, 2011
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed