A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
1 other identifier
interventional
15
1 country
5
Brief Summary
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, 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 Oct 2007
Typical duration for phase_4 rheumatoid-arthritis
5 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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
June 10, 2014
CompletedJune 10, 2014
June 1, 2014
3.1 years
July 6, 2009
May 7, 2014
June 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an Adverse Event (AE)
Week 104
Secondary Outcomes (3)
Disease Activity Score Based on 28-Joint Count (DAS28)
Day 1 and Week 24
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category
Screening, Day 1, and Weeks 24 and 104
Percentage of Participants With Changes in Bone Density
Screening, Weeks 48 and 104
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- receiving out-patient treatment;
- experienced an inadequate response to previous or current treatment with methotrexate.
You may not qualify if:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- history of, or current, inflammatory joint disease other than RA;
- previous treatment with any cell-depleting therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Casablanca, 20000, Morocco
Unknown Facility
Casablanca, 20100, Morocco
Unknown Facility
Marrakesh, 40000, Morocco
Unknown Facility
Rabat, 10150, Morocco
Unknown Facility
Salé, 15045, Morocco
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 6, 2009
First Posted
July 8, 2009
Study Start
October 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 10, 2014
Results First Posted
June 10, 2014
Record last verified: 2014-06