An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392001
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months .

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 322 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.
Study Start Date : March 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra [ Time Frame: approximately 29 months ]

Secondary Outcome Measures :
  1. Efficacy: Disease activity score (DAS 28) [ Time Frame: approximately 29 months ]
  2. Co-medications: dosage and treatment schedules [ Time Frame: approximately 29 months ]
  3. Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI) [ Time Frame: approximately 29 months ]
  4. Safety: Incidence of adverse events [ Time Frame: approximately 29 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rheumatoid arthritis patients on treatment with RoActemra/Actemra and > 5 mg/day prednisone (or equivalent)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
  • Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months

Exclusion Criteria:

  • Participation in a clinical trial in rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01392001

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01392001     History of Changes
Other Study ID Numbers: ML25634
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs