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This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | As prescribed |
| |
| rituximab [MabThera/Rituxan] |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, including infusion-related adverse events | For 48 weeks after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of re-treatment (AEs) | For 24 weeks after re-treatment. | |
| Laboratory parameters, vital signs. | Throughout study | |
| ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelyabinsk | 454076 | Russia | ||||
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| Drug |
1000mg iv on days 1 and 15 |
|
| For 48 weeks after initial treatment. |
| Irkutsk |
| 664047 |
| Russia |
| Kazan' | 420012 | Russia |
| Khabarovsk | 680009 | Russia |
| Khanty-Mansiysk | 628011 | Russia |
| Kursk | 305007 | Russia |
| Moscow | 115522 | Russia |
| Nizhny Novgorod | 603126 | Russia |
| Novosibirsk | 630099 | Russia |
| Novosibirsk | 630117 | Russia |
| Ryazan | 390026 | Russia |
| Saint Petersburg | 195067 | Russia |
| Tyumen | 625023 | Russia |
| Ufa | 450005 | Russia |
| Vladivostok | 690050 | Russia |
| Voronezh | 394066 | Russia |
| Yaroslavl | 150062 | Russia |
| Yekaterinburg | 620102 | Russia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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