A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.
1 other identifier
interventional
378
18 countries
91
Brief Summary
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Feb 2006
Longer than P75 for phase_3 rheumatoid-arthritis
91 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
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 15, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 4, 2015
CompletedMay 4, 2015
April 1, 2015
7.1 years
January 15, 2007
December 9, 2014
April 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)
ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain (visual analog assessment \[VAS\]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing
Week 48
Secondary Outcomes (37)
Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48
Week 48
Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48
Week 48
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48
BL, Week 48
Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category
Week 48
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48
BL, Week 48
- +32 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- RA for \>=6 months;
- receiving outpatient treatment;
- inadequate response to methotrexate, having received and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.
You may not qualify if:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- inflammatory joint disease other than RA, or other systemic autoimmune disorder;
- diagnosis of juvenile arthritis, or RA before the age of 16;
- previous treatment with \>1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Unknown Facility
Coffs Harbour, New South Wales, 2450, Australia
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Sydney, New South Wales, 2145, Australia
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Maroochydore, Queensland, 4558, Australia
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Southport, Queensland, 4215, Australia
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Malvern, Victoria, 3144, Australia
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Melbourne, Victoria, 3168, Australia
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Ghent, 9000, Belgium
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Goiânia, Goiás, 74110010, Brazil
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São Paulo, São Paulo, 04266-010, Brazil
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Penticton, British Columbia, V2A 3G8, Canada
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Victoria, British Columbia, V8V 3P9, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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London, Ontario, N6A 4V2, Canada
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Newmarket, Ontario, L3Y 3R7, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Trois-Rivières, Quebec, G8Z 1Y2, Canada
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Beijing, 100029, China
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Beijing, 100853, China
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Oulu, 90220, Finland
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Bois-Guillaume, 76233, France
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Bordeaux, 33076, France
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Dijon, 21000, France
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Le Mans, 72037, France
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Lille, 59037, France
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Montpellier, 34295, France
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Nice, 06202, France
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Paris, 75679, France
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Bad Nauheim, 61231, Germany
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Cologne, 50924, Germany
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Hamburg, 22081, Germany
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Heidelberg, 69120, Germany
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Herne, 44652, Germany
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Osnabrück, 49074, Germany
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Ratingen, 40882, Germany
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Debrecen, 4032, Hungary
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Eger, 3300, Hungary
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Coppito, Abruzzo, 67100, Italy
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Potenza, Basilicate, 85100, Italy
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Ferrara, Emilia-Romagna, 44100, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Arenzano, Liguria, 16011, Italy
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Genoa, Liguria, 16132, Italy
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Pieve di Coriano, Lombardy, 46020, Italy
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Turin, Piedmont, 10128, Italy
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Palermo, Sicily, 90127, Italy
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Pisa, Tuscany, 56100, Italy
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Prato, Tuscany, 59100, Italy
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Siena, Tuscany, 53100, Italy
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Valeggio sul Mincio, Veneto, 37067, Italy
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Amsterdam, 1105 AZ, Netherlands
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Leiden, 2333 ZA, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Auckland, 0620, New Zealand
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Christchurch, 8022, New Zealand
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Timaru, 7910, New Zealand
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Košice, 040 01, Slovakia
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Piešťany, 921 01, Slovakia
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Piešťany, 921 12, Slovakia
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Cape Town, 7925, South Africa
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Diepkloof, 1862, South Africa
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Pretoria, 0083, South Africa
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Barcelona, Barcelona, 08907, Spain
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Burgos, Burgos, 06006, Spain
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León, Leon, 24071, Spain
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Madrid, Madrid, 28006, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28905, Spain
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Gijón, Principality of Asturias, 33394, Spain
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Seville, Sevilla, 41014, Spain
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Kaohsiung City, 00833, Taiwan
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Taichung, 407, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Barnsley, S75 2EP, United Kingdom
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Birmingham, B29 6JD, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Glasgow, G4 OSF, United Kingdom
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London, E11 1NR, United Kingdom
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Londonderry, BT47 6SB, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Northampton, NN1 5BD, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Wigan, WN6 9EW, United Kingdom
Related Publications (1)
Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreno L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.
PMID: 20463186DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2007
First Posted
January 17, 2007
Study Start
February 1, 2006
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 4, 2015
Results First Posted
May 4, 2015
Record last verified: 2015-04