Clinical trial NCT01272908: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary
timeFrame: Days 1, 2, 15, and 16 and Week 48 of Initial treatment period
Secondary outcomes:
measure: Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary
timeFrame: Days 1, 2, 15, and 16 and Week 48 of Re-treatment period
measure: Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in DAS28 During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in DAS28 During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in SJC During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in SJC During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in TJC During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in TJC During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance
measure: Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline HAQ-DI Score During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline HAQ-DI Score During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in ESR During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in ESR During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in CRP During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline CRP During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period
timeFrame: Weeks 4, 12, 24, 36, and 48 of Initial treatment period
measure: Change From Baseline in FACIT-F Total Score During the Re-Treatment Period
timeFrame: Weeks 12 and 24 of Re-treatment period
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Nepean
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Sainte-foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St-eustache
country: Canada
state: Quebec
city: Trois-rivieres
country: Canada
state: Quebec
city: Boras
country: Sweden
city: Falun
country: Sweden
city: Goeteborg
country: Sweden
city: Jonkoping
country: Sweden
city: Kalmar
country: Sweden
city: Karlskrona
country: Sweden
city: Lulea
country: Sweden
city: Malmoe
country: Sweden
city: Oskarstroem
country: Sweden
city: Skoevde
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: