Working… Menu

A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01952509
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

Condition or disease
Rheumatoid Arthritis

Layout table for study information
Study Type : Observational
Actual Enrollment : 169 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.
Study Start Date : October 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation [ Time Frame: approximately 2 years ]

Secondary Outcome Measures :
  1. Rates of dose modifications/interruptions [ Time Frame: approximately 2 years ]
  2. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 2 years ]
  3. Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6 [ Time Frame: approximately 2 years ]
  4. Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 2 years ]
  5. Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
  6. Health Assessment Questionnaire Disability Index [ Time Frame: approximately 2 years ]
  7. Visual Analogue Scale - Fatigue [ Time Frame: approximately 2 years ]
  8. Visual Analogue Scale - severity of pain [ Time Frame: approximately 2 years ]
  9. Visual Analogue Scale - morning stiffness [ Time Frame: aproximately 2 years ]
  10. Patient Global Assessment of disease activity [ Time Frame: approximately 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe rheumatoid arthritis initiating treatment with RoActemra/Actemra in accordance with the local label

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01952509

Layout table for location information
Costa Rica
Cartago, Costa Rica, 0
San Jose, Costa Rica, 0
Dominican Republic
Santo Domingo, Dominican Republic, 10208
Ciudad de Guatemala, Guatemala
Panama City, Panama, 32400
Panama, Panama
Sponsors and Collaborators
Hoffmann-La Roche
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche Identifier: NCT01952509     History of Changes
Other Study ID Numbers: ML28747
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases