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NCT Number: NCT01564901

An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

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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

Vitoria-Gasteiz, Alava, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults patients, over 18 years of age
  • Patients with moderate to severe rheumatoid arthritis (RA)
  • Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion criteria

  • Patients previously treated with RoActemra/Actemra
  • Any contraindication to RoActemra/Actemra

Treatment and study plan

Primary outcomes

  1. Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day

    Time frame: Week 36

Secondary outcomes

  1. Change from baseline in glucocorticoid dose

    Time frame: Week 36

  2. Change from baseline in corticosteroid dose

    Time frame: Week 36

  3. Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose

    Time frame: Week 36

  4. Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids

    Time frame: Week 36

  5. Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use

    Time frame: Week 36

  6. Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day

    Time frame: Week 36

  7. Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day

    Time frame: Week 36

  8. Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction

    Time frame: Week 36

  9. Percentage change in Disease Activity Score 28 (DAS28)

    Time frame: Week 36

  10. Percentage change in Simplified Disease Activity Index (SDAI) score

    Time frame: Week 36

  11. Safety: Incidence of adverse events

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 28, 2012
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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