An Observational Study to Evaluate RoActemra/Actemra (Tocilizumab) Treatment in a Real-Life Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664104
First received: August 7, 2012
Last updated: April 7, 2014
Last verified: April 2014

August 7, 2012
April 7, 2014
June 2012
December 2013   (final data collection date for primary outcome measure)
Dosage/schedule used in routine clinical practice [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664104 on ClinicalTrials.gov Archive Site
  • Change in treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical patient characteristics at the time of treatment initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disease activity according to joint count evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of C-reactive protein and treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of body mass index (BMI) with treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of C-reactive protein with disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of body mass index with disability disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study to Evaluate RoActemra/Actemra (Tocilizumab) Treatment in a Real-Life Setting
CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of RoActemra/Actemra (tocilizumab) therapy in a routine clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected for 6 months.

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

Patients with rheumatoid arthritis treated with RoActemra/Actemra according to routine clinical practice.

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
152
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of moderate to severe rheumatoid arthritis
  • Patients have started RoActemra/Actemra treatment according to routine clinical practice within 3 months prior to study start
  • Patients have been given oral and written information about the study and have signed the informed consent form

Exclusion Criteria:

  • Patients who have started RoActemra/Actemra treatment more than 3 months prior to site opening
  • Patients who have previously received RoActemra/Actemra in a clinical trial setting or for compassionate use
  • Patients who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
  • Patients with a history of autoimmune disease or joint inflammatory disease other than rheumatoid arthritis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01664104
ML28336
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