Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

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.
 
ClinicalTrials.gov Identifier: NCT01564901
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date February 16, 2012
First Posted Date March 28, 2012
Last Update Posted Date November 2, 2016
Study Start Date January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2012)
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day [ Time Frame: Week 36 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2012)
  • Change from baseline in glucocorticoid dose [ Time Frame: Week 36 ]
  • Change from baseline in corticosteroid dose [ Time Frame: Week 36 ]
  • Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose [ Time Frame: Week 36 ]
  • Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids [ Time Frame: Week 36 ]
  • Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use [ Time Frame: Week 36 ]
  • Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  • Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  • Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction [ Time Frame: Week 36 ]
  • Percentage change in Disease Activity Score 28 (DAS28) [ Time Frame: Week 36 ]
  • Percentage change in Simplified Disease Activity Index (SDAI) score [ Time Frame: Week 36 ]
  • Safety: Incidence of adverse events [ Time Frame: 36 weeks ]
Original Secondary Outcome Measures
 (submitted: March 27, 2012)
  • Change from baseline in glucocorticoid dose [ Time Frame: Week 36 ]
  • Change from baseline in corticosteroid dose [ Time Frame: Week 36 ]
  • Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose [ Time Frame: Week 36 ]
  • Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids [ Time Frame: Week 36 ]
  • Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use [ Time Frame: Week 36 ]
  • Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  • Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day [ Time Frame: Week 36 ]
  • Proportion of patients meeting the physician's recommendations for ucocorticoid dose reduction [ Time Frame: Week 36 ]
  • Percentage change in Disease Activity Score 28 (DAS28) [ Time Frame: Week 36 ]
  • Percentage change in Simplified Disease Activity Index (SDAI) score [ Time Frame: Week 36 ]
  • Safety: Incidence of adverse events [ Time Frame: 36 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
Official Title A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
Brief Summary This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 3, 2013)
23
Original Estimated Enrollment
 (submitted: March 27, 2012)
120
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults patients, over 18 years of age
  • Patients with moderate to severe rheumatoid arthritis (RA)
  • Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria:

  • Patients previously treated with RoActemra/Actemra
  • Any contraindication to RoActemra/Actemra
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01564901
Other Study ID Numbers ML27904
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016