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OpenTrials
Completed

NCT Number: NCT01770834

A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

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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

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Safat, Kuwait

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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, >/= 21 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
  • Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
  • Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion criteria

  • Pregnant or lactating women
  • Contra-indication to RoActemra/Actemra treatment according to the local labelling
  • Previous treatment with tocilizumab
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Women of childbearing potential not using effective methods of contraception as defined by protocol

Treatment and study plan

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 3 years

Secondary outcomes

  1. Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)

    Time frame: approximately 3 years

  2. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment

    Time frame: approximately 3 years

  3. Treatment regimens: Concomitant medications

    Time frame: approximately 3 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2013
Registry last updated
Mar 2, 2018

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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