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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01462162
First received: October 27, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 126
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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 Rheumatoid Arthritis

Criteria

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

Contacts
Contact: Please reference Study ID Number: ML27833 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Spain
Active, not recruiting
A Coruña, Spain, 15405
Completed
Barcelona, Spain, 08907
Recruiting
Barcelona, Spain, 08035
Recruiting
Cartagenas, Spain
Recruiting
Girona, Spain, 17002
Recruiting
Hospitalet de Llobregat, Spain, 08906
Recruiting
Lorca, Spain, 30800
Active, not recruiting
Lugo, Spain, 27880
Recruiting
Mollet Del Valles, Spain, 08100
Recruiting
Murcia, Spain, 30120
Recruiting
Ourense, Spain, 32005
Active, not recruiting
Sabadell, Spain, 08208
Recruiting
Sant Joan Despi, Spain, 08970
Active, not recruiting
Tarragona, Spain, 43204
Recruiting
Tarragona, Spain, 43003
Recruiting
Vigo, Spain, 36204
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: NCT01462162     History of Changes
Other Study ID Numbers: ML27833
Study First Received: October 27, 2011
Last Updated: May 13, 2013
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on May 16, 2013