TriangleNCT00074438 · CITED IN SOURCE DOCUMENTS
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2013-05-09
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Eligibility criteria include, but are not limited to the following: * Are between the ages of 18 and 80 years. * Have been diagnosed with rheumatoid arthritis for at least 6 months. * Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).
- healthy Volunteers
- false
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- label
- 1
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- Drug: corticosteroids
- label
- 2
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- Drug: corticosteroids
- label
- 3
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- label
- 4
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- Drug: corticosteroids
- label
- 5
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: rituximab
- Drug: corticosteroids
- label
- 6
- type
- EXPERIMENTAL
- intervention Names
- Drug: methotrexate
- Drug: placebo
- label
- 7
- type
- PLACEBO_COMPARATOR
- intervention Names
- Drug: methotrexate
- Drug: corticosteroids
- Drug: placebo
- label
- 8
- type
- PLACEBO_COMPARATOR
- intervention Names
- Drug: methotrexate
- Drug: corticosteroids
- Drug: placebo
- label
- 9
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- description
- Oral or parenteral repeating dose
- name
- methotrexate
- type
- DRUG
- arm Group Labels
- 1
- 2
- 3
- 4
- 5
- 6
- description
- Intravenous repeating dose
- name
- rituximab
- type
- DRUG
- arm Group Labels
- 2
- 3
- 5
- 6
- 8
- 9
- description
- Intravenous repeating dose
- name
- corticosteroids
- type
- DRUG
- arm Group Labels
- 7
- 8
- 9
- description
- Intravenous repeating dose
- name
- placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 465
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Proportion of patients with an ACR20 response
- time Frame
- 24 weeks
- secondary Outcomes
- measure
- Proportion of patients with ACR(50,70) responses
- time Frame
- 24 weeks
- measure
- Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
- time Frame
- 24 weeks
Full study description
- brief Summary
- This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
Source references
- 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.
- pmid
- 18050221
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- atoid Arthritis The data presented below reflect the experience in 2,578 RA patients treated with rituximab in controlled and long-term studies Pooled studies: NCT00074438, NCT00422383, NCT00468546, NCT00299130, NCT00282308, NCT00266227, NCT02693210, NCT02093026 and NCT02097745. with a total exposure of 5,014 patient-years. Among
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- ved in practice. The data presented below reflect the experience in 2578 RA patients treated with rituximab in controlled and long-term studies Pooled studies: NCT00074438, NCT00422383, NCT00468546, NCT00299130, NCT00282308, NCT00266227, NCT02693210, NCT02093026 and NCT02097745 with a total exposure of 5014 patient-years. Among a
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- eumatoid Arthritis The data presented below reflect the experience in 2578 RA patients treated with RITUXAN in controlled and long-term studies Pooled studies: NCT00074438, NCT00422383, NCT00468546, NCT00299130, NCT00282308, NCT00266227, NCT02693210, NCT02093026 and NCT02097745. with a total exposure of 5014 patient-years. Among
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- atoid Arthritis The data presented below reflect the experience in 2,578 RA patients treated with rituximab in controlled and long-term studies Pooled studies: NCT00074438, NCT00422383, NCT00468546, NCT00299130, NCT00282308, NCT00266227, NCT02693210, NCT02093026 and NCT02097745. with a total exposure of 5,014 patient-years. Among
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Preserved source evidence · Not medical advice