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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392001
First received: July 8, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra [ Time Frame: approximately 29 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Disease activity score (DAS 28) [ Time Frame: approximately 29 months ] [ Designated as safety issue: No ]
  • Co-medications: dosage and treatment schedules [ Time Frame: approximately 29 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 29 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

unknown


Enrollment: 322
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392001

  Show 117 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392001     History of Changes
Other Study ID Numbers: ML25634
Study First Received: July 8, 2011
Last Updated: April 14, 2014
Health Authority: France: Commission Nationale de lInformatique et des Libertes (CNIL)

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

ClinicalTrials.gov processed this record on April 23, 2014