An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis
A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)
1 other identifier
observational
135
1 country
14
Brief Summary
This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2012
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedOctober 24, 2016
August 1, 2016
3.6 years
May 25, 2012
August 31, 2016
August 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.
Baseline, Month 6, Month 12
Secondary Outcomes (15)
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12
Baseline, Month 6, Month 12
Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12
Baseline, Month 6, Month 12
Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12
Baseline, Month 6, Month 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12
Baseline, Month 6, Month 12
Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12
Baseline, Month 6, Month 12
- +10 more secondary outcomes
Study Arms (1)
Rituximab
Rituximab administered according to prescribing information and normal clinical practice.
Interventions
Rituximab administered according to prescribing information and normal clinical practice.
Eligibility Criteria
Participants with severe active, seropositive rheumatoid arthritis who have an inadequate response or intolerance to anti-TNF therapy
You may qualify if:
- Age \>18 years with rheumatoid arthritis (RA)
- Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\])
- Active disease despite receiving one or more TNF inhibitors
- Absence of serious or active infection
You may not qualify if:
- Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease
- Participants pregnant or lactating
- Prior treatment with Mabthera®
- Participants receiving any other investigational product in the context of other clinical study
- Participants with known hypersensitivity to rituximab or to any of the excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Athens, 11521, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Athens, 14527, Greece
Unknown Facility
Athens, 155 62, Greece
Unknown Facility
Haidari, 124 62, Greece
Unknown Facility
Heraklion, 71110, Greece
Unknown Facility
Ioannina, 455 00, Greece
Unknown Facility
Larissa, 411 10, Greece
Unknown Facility
Pátrai, 26335, Greece
Unknown Facility
Pátrai, 265 04, Greece
Unknown Facility
Thessaloniki, 544 65, Greece
Unknown Facility
Thessaloniki, 546 42, Greece
Unknown Facility
Thessaloniki, 57010, Greece
Unknown Facility
Voula, 16673, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2012
First Posted
June 6, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 24, 2016
Results First Posted
October 24, 2016
Record last verified: 2016-08