A Prospective Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01462162
First received: October 27, 2011
Last updated: April 7, 2014
Last verified: April 2014

October 27, 2011
April 7, 2014
September 2011
November 2013   (final data collection date for primary outcome measure)
Change in fatigue outcome assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) from baseline to month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01462162 on ClinicalTrials.gov Archive Site
  • Change in fatigue score as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in hemoglobin value [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Disease Activity Score (DAS28) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in European League Against Rheumatism Score (EULAR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in swollen joint count (SJC28) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Prospective Observational Study to Assess Impact on Fatigue of RA Patients Treated With Roactemra in the Real Life Setting

This prospective observational study will investigate the effect of RoActemra/Actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-TNF drugs. Data will be collected from patients for 6 months.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult Patients, >/=18 years of age
  • Patients wih Rheumatoid Arthritis (RA)

Exclusion Criteria:

  • Patients previously or currently treated with RoActemra/Actemra in clinical trials
  • Absolute neutrophile count </=2x10 9/l
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01462162
ML27833
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP