A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.
An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.
1 other identifier
interventional
36
1 country
10
Brief Summary
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 rheumatoid-arthritis
Started Jul 2007
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedAugust 4, 2014
July 1, 2014
2.7 years
July 19, 2007
July 9, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)
DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour \[mm/hr\]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.
Week 24
Secondary Outcomes (3)
Percentage of Participants Achieving American College of Rheumatology (ACR) Response
Week 24
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category
Week 24
Change From Baseline in HAQ-DI Score
Week 24
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- active rheumatoid arthritis;
- receiving outpatient treatment;
- an inadequate response, or intolerance, to \>=1 anti-TNF agent.
You may not qualify if:
- other rheumatic autoimmune disease or inflammatory joint disease;
- concurrent treatment with any anti-TNF-alpha therapy;
- joint or osseous surgery during 8 weeks prior to recruitment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Changhua, 500, Taiwan
Unknown Facility
Kaohsiung City, 00833, Taiwan
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Kaohsiung City, 813, Taiwan
Unknown Facility
Taichung, 402, Taiwan
Unknown Facility
Taichung, 404, Taiwan
Unknown Facility
Taichung, 407, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Tapei, 114, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
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
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 20, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 4, 2014
Results First Posted
August 4, 2014
Record last verified: 2014-07