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NCT Number: NCT01337388

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

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.

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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

Bergen, Norway

Loading trial locations.

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
  • 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

Treatment and study plan

Primary outcomes

  1. Change in disease activity score (DAS 28)

    Time frame: 12 months

  2. Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice

    Time frame: 36 months

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 36 months

  2. Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire

    Time frame: 12 months

  3. Rate of patients achieving remission (DAS <2.6)

    Time frame: 36 months

  4. Change in blood lipids

    Time frame: 12 months

  5. Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 18, 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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