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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01564901
First received: February 16, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in glucocorticoid dose [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change from baseline in corticosteroid dose [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Percentage change in Disease Activity Score 28 (DAS28) [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Percentage change in Simplified Disease Activity Index (SDAI) score [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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

Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564901

Locations
Spain
Alicante, Spain, 03700
Alzira, Spain, 46600
Bilbao, Spain, 48013
Elche, Spain, 03203
Huesca, Spain, 22004
Leon, Spain, 24071
Palma de Mallorca, Spain, 07198
Ponferrada, Spain, 24411
Salamanca, Spain, 37007
San Sebastian, Spain, 20080
Valencia, Spain, 46340
Valencia, Spain, 46520
Vitoria, Spain, 01009
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: NCT01564901     History of Changes
Other Study ID Numbers: ML27904
Study First Received: February 16, 2012
Last Updated: March 4, 2013
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

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 May 19, 2013