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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: October 27, 2011
Last updated: October 1, 2015
Last verified: October 2015
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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Assess Impact on Fatigue of RA Patients Treated With Roactemra in the Real Life Setting

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 122
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)


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 Rheumatoid Arthritis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462162

Hospitalet de Llobregat, Barcelona, Spain, 08906
Mollet del Valles, Barcelona, Spain, 08100
Sabadell, Barcelona, Spain, 08208
Sant Joan Despi, Barcelona, Spain, 08970
A Coruña, La Coruña, Spain, 15405
Cartagena, Murcia, Spain, 30203
El Palmar, Murcia, Spain, 30120
Lorca, Murcia, Spain, 30800
Ourense, Orense, Spain, 32005
Vigo, Pontevedra, Spain, 36204
Barcelona, Spain, 08035
Barcelona, Spain, 08907
Girona, Spain, 17002
Lugo, Spain, 27880
Tarragona, Spain, 43003
Tarragona, Spain, 43204
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01462162     History of Changes
Other Study ID Numbers: ML27833
Study First Received: October 27, 2011
Last Updated: October 1, 2015
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2015