Clinical trial NCT02097745: A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Official title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2014-03-27
Enrollment: 341
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 assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients 18-80 years of age with active RA;
* patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
* eligible for re-treatment, based on clinical symptoms;
* patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

* patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
* current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
* development of any new contraindications to receiving MabThera;
* women who are pregnant or breast-feeding.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
Secondary outcomes:
measure: Change From Baseline in the Disease Activity Score 28 (DAS28)
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Change From Baseline in the American College of Rheumatology n (ACRn) Response
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
timeFrame: Baseline to the end of the retreatment period (up to 7 years, 6 months)
measure: Percentage of Participants With no Radiographic Progression From Baseline to Year 5
timeFrame: Baseline to Year 5
measure: Change From Baseline in the Total Genant-modified Sharp Score at Year 5
timeFrame: Baseline to Year 5
measure: Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5
timeFrame: Baseline to Year 5
measure: Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5
timeFrame: Baseline to Year 5
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5
timeFrame: Baseline to Year 5
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Paradise Valley
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Fullerton
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Coeur D'alene
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Shreverport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mayfield
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Amarillo
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Seattle
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Bois Guillaume
country: France
city: Le Kremlin Bicetre
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Leipzig
country: Germany
city: Ratingen
country: Germany
city: Würzburg
country: Germany
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Brescia
country: Italy
state: Lombardia
city: Pisa
country: Italy
state: Toscana
city: Amsterdam
country: Netherlands
city: Drammen
country: Norway
city: Oslo
country: Norway
city: Tromsø
country: Norway
city: Cannock
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059.