A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis
NCT ID: NCT02693210
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2001-02-28
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A: Methotrexate
Participants will receive methotrexate at dosage \>=10 milligrams per week (mg/week) orally as determined by the investigator. They also receive placebo infusion on days 1 and 15 in place of rituximab and on Days 3 and 17 in place of cyclophosphamide.
Methotrexate
Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
Placebo Cyclophosphamide
Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
Placebo Rituximab
Participants will receive placebo in place of rituximab on days 1 and 15
Group B: Rituximab Monotherapy
Participants will receive 1 g intravenous infusions of rituximab on Days 1 and 15. They also receive Weekly placebo orally instead of methotrexate and placebo infusion in place of cyclophosphamide on Days 3 and 17.
Placebo Cyclophosphamide
Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
Placebo Methotrexate
Participants will receive weekly oral placebo in place of Methotrexate
Rituximab
Participants will receive 1g infusions of rituximab on Days 1 and 15
Group C: Rituximab and Cyclophosphamide
Participants will receive 1g IV infusion of rituximab on Days 1 and 15 and 750 mg infusion of Cyclophosphamide on Days 3 and 17. They also receive weekly oral placebo in place of methotrexate.
Cyclophosphamide
Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
Placebo Methotrexate
Participants will receive weekly oral placebo in place of Methotrexate
Rituximab
Participants will receive 1g infusions of rituximab on Days 1 and 15
Group D: Methotrexate and Rituximab
Participants will receive \>=10 mg/week methotrexate orally along with 2 times 1 gram (g) rituximab IV infusions on Days 1 and 15. Participants will also receive placebo infusions on Days 3 and 17 in place of cyclophosphamide.
Methotrexate
Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
Placebo Cyclophosphamide
Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
Rituximab
Participants will receive 1g infusions of rituximab on Days 1 and 15
Interventions
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Cyclophosphamide
Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
Methotrexate
Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
Placebo Cyclophosphamide
Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
Placebo Methotrexate
Participants will receive weekly oral placebo in place of Methotrexate
Placebo Rituximab
Participants will receive placebo in place of rituximab on days 1 and 15
Rituximab
Participants will receive 1g infusions of rituximab on Days 1 and 15
Eligibility Criteria
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Inclusion Criteria
* Using methotrexate as a single DMARD for at least 16 weeks, of which the last 4 weeks prior to baseline on a stable oral dose greater than or equal to (\>=) 10 milligrams per week (mg/week)
* \>=21 years of age
* Swollen Joint Count (SJC) and Tender Joint Count (TJC) \>= 8 (out of 66 and 68 joints respectively)
* At least 2 of the following parameters at Baseline: C- Reactive Protein \>= 15 mg/dL; Erythrocyte Sedimentation Rate \>= 30 millimeters per hour (mm/hr); Morning stiffness \>45 minutes
* Rheumatoid factor titer \>=20 International units per milliliter (IU/mL)
* Corticosteroid (less than or equal to \[=\<\] 12.5 milligrams per deciliter \[mg/d\] prednisone or equivalent) or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are permitted if stable for at least 4 weeks prior to baseline
Exclusion Criteria
* Concurrent treatment with any DMARD (apart from randomized treatment) or anti-TNF-alpha therapy
* Active infection or history of recurrent significant infection
* Prior history of cancer including solid tumors and hematologic malignancies (except basal carcinoma of the skin that have been excised and cured)
* Evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
* Bone/joint surgery within 6 weeks prior to screening
* Rheumatic Autoimmune disease other than RA
* Active rheumatoid vasculitis
* Prior history of gout
* Chronic fatigue syndrome
21 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hofffmann-La Roche
Locations
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Darlinghurst, , Australia
Kogarah, , Australia
Woodville, , Australia
Diepenbeek, , Belgium
Ghent, , Belgium
Liège, , Belgium
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Prague, , Czechia
Leipzig, , Germany
Ratingen, , Germany
Wiesbaden, , Germany
Haifa, , Israel
Haifa, , Israel
Brescia, , Italy
Genova, , Italy
Modena, , Italy
Siena, , Italy
Leiden, , Netherlands
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Guadalajara, , Spain
Madrid, , Spain
Madrid, , Spain
San Cristóbal de La Laguna, , Spain
Seville, , Spain
Cannock, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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WA16291
Identifier Type: -
Identifier Source: org_study_id