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An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

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: NCT01075477
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date February 24, 2010
First Posted Date February 25, 2010
Last Update Posted Date November 2, 2016
Study Start Date September 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2010)
Efficacy: DAS28 [ Time Frame: 29 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 24, 2010)
  • Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) [ Time Frame: 29 months ]
  • Safety: serious and non-serious adverse events [ Time Frame: 29 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)
Official Title Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines
Brief Summary This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.
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 rheumatoid arthritis on or commencing treatment with rituximab [MabThera]
Condition Rheumatoid Arthritis
Intervention Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician
Study Groups/Cohorts Cohort
Intervention: Drug: rituximab [Mabthera/Rituxan]
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: August 20, 2012)
151
Original Estimated Enrollment
 (submitted: February 24, 2010)
120
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • rheumatoid arthritis
  • treatment with rituximab

Exclusion Criteria:

  • unable/unwilling to give informed consent to data collection
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 Finland
Removed Location Countries United States
 
Administrative Information
NCT Number NCT01075477
Other Study ID Numbers ML22609
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