A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)
1 other identifier
interventional
120
2 countries
41
Brief Summary
This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jul 2006
41 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
July 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedResults Posted
Study results publicly available
August 5, 2014
CompletedAugust 15, 2017
June 1, 2017
2.7 years
January 7, 2011
May 12, 2014
July 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary
Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.
Days 1, 2, 15, and 16 and Week 48 of Initial treatment period
Secondary Outcomes (29)
Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary
Days 1, 2, 15, and 16 and Week 48 of Re-treatment period
Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period
Weeks 4, 12, 24, 36, and 48 of Initial treatment period
Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period
Weeks 12 and 24 of Re-treatment period
Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period
Weeks 12 and 24 of Re-treatment period
- +24 more secondary outcomes
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, 18-80 years of age
- Moderate to severe active rheumatoid arthritis
- Inadequate response to a single previous or current treatment with an anti-TNF agent
- Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks
You may not qualify if:
- Previous treatment with MabThera
- Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
- Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
- Active infection, or history of serious or chronic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Edmonton, Alberta, T5M 0H4, Canada
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 3G8, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 3Y1, Canada
Unknown Facility
Victoria, British Columbia, V8V 3P9, Canada
Unknown Facility
Winnipeg, Manitoba, R3A 1M4, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Unknown Facility
Hamilton, Ontario, L8N 1Y2, Canada
Unknown Facility
Hamilton, Ontario, L8S 4J9, Canada
Unknown Facility
Mississauga, Ontario, L5M 2V8, Canada
Unknown Facility
Nepean, Ontario, K2G 6E2, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Unknown Facility
Ottawa, Ontario, K1S 1C2, Canada
Unknown Facility
Thunder Bay, Ontario, P7B 5G3, Canada
Unknown Facility
Toronto, Ontario, M4K 1N2, Canada
Unknown Facility
Toronto, Ontario, M5G 1X5, Canada
Unknown Facility
Toronto, Ontario, M5T 2S8, Canada
Unknown Facility
Windsor, Ontario, N8X 5A6, Canada
Unknown Facility
Laval, Quebec, H7G 2E6, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H2L 1S6, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Québec, Quebec, G1V 3M7, Canada
Unknown Facility
Saint-Eustache, Quebec, J7P 4J2, Canada
Unknown Facility
Sainte-Foy, Quebec, G1W 4R4, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 5N4, Canada
Unknown Facility
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Unknown Facility
Borås, 50182, Sweden
Unknown Facility
Falun, 79182, Sweden
Unknown Facility
Gothenburg, 41345, Sweden
Unknown Facility
Jönköping, 551 85, Sweden
Unknown Facility
Kalmar, 39185, Sweden
Unknown Facility
Karlskrona, 37185, Sweden
Unknown Facility
Luleå, 97180, Sweden
Unknown Facility
Malmo, 20502, Sweden
Unknown Facility
Oskarström, 31392, Sweden
Unknown Facility
Skövde, 54185, Sweden
Unknown Facility
Stockholm, 18288, Sweden
Unknown Facility
Sundsvall, 85186, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY CHAIR
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 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
July 18, 2006
Primary Completion
March 12, 2009
Study Completion
March 12, 2009
Last Updated
August 15, 2017
Results First Posted
August 5, 2014
Record last verified: 2017-06