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

• ClinicalTrials.gov Identifier: NCT01075477
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: November 2, 2016
• Sponsor: Hoffmann-La Roche
• 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

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

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