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OpenTrials
Completed

NCT Number: NCT01388309

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

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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

  1. Disease activity score (DAS28)

    Time frame: 12 months

Secondary outcomes

  1. DAS 28 (subgroup on monotherapy)

    Time frame: 12 months

  2. DAS 28 (subgroup on 4 mg/kg dose)

    Time frame: 12 months

  3. 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.

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