An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01375478
First received: June 16, 2011
Last updated: August 4, 2014
Last verified: August 2014

June 16, 2011
August 4, 2014
April 2011
April 2012   (final data collection date for primary outcome measure)
Percentage of patients who remained under continued RoActemra/Actemra treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01375478 on ClinicalTrials.gov Archive Site
  • Reasons for withdrawal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of withdrawal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of dose modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reasons for dose modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)

This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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
197
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, over 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria:

  • Patients with rheumatic autoimmune disease other than rheumatoid arthritis
  • Patients who are not willing to sign the informed consent form
  • Patients who participate in interventional trials during the period of this observational study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01375478
ML25580
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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