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WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Methotrexate | Active Comparator | 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. |
|
| Group B: Rituximab Monotherapy | Experimental | 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. |
|
| Group C: Rituximab and Cyclophosphamide | Experimental | 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. |
|
| Group D: Methotrexate and Rituximab | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving American College of Rheumatology (ACR) 50 response at Week 24 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving ACR 20 and ACR 70 responses at Week 24 | Week 24 | |
| Area Under the Curve (AUC) of American College of Rheumatology Response (ACRn) | Baseline up to Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hofffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darlinghurst | 2010 | Australia | ||||
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| Methotrexate | Drug | Participants will receive >= 10 mg/week methotrexate orally up to 24 weeks |
|
| Placebo Cyclophosphamide | Other | Participants will receive placebo in place of cyclophosphamide on Days 3 and 17 |
|
| Placebo Methotrexate | Other | Participants will receive weekly oral placebo in place of Methotrexate |
|
| Placebo Rituximab | Other | Participants will receive placebo in place of rituximab on days 1 and 15 |
|
| Rituximab | Drug | Participants will receive 1g infusions of rituximab on Days 1 and 15 |
|
| AUC of the mean Disease Activity Scores (DAS) |
| Baseline up to Week 24 |
| Change from Baseline in the Swollen Joint Count | Baseline, Weeks 12, 16, 20 and 24 |
| Change from Baseline in the Tender Joint Count | Baseline, Weeks 12, 16, 20 and 24 |
| Change from Baseline in participant's global assessment of disease activity using a Visual Analog Scale (VAS) | Baseline, Weeks 8, 12, 16, 20 and 24 |
| Change from Baseline in physician's global assessment of disease activity using VAS | Baseline, Weeks 8, 12, 16, 20 and 24 |
| Change from Baseline in the Health Assessment Questionnaire - Disease Index (HAQ-DI) scores | Baseline, Weeks 12, 16, 20 and 24 |
| Change from Baseline in participant's pain measured by VAS | Baseline, Weeks 12, 16, 20 and 24 |
| Change from Baseline in C-Reactive Protein (CRP) Levels | Baseline, Weeks 12, 16, 20 and 24 |
| Change from Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline, Weeks 12, 16, 20 and 24 |
| Mean change in Rheumatoid factor levels at 24 weeks | Baseline and Week 24 |
| Percentage of participants who withdrew due to insufficient therapeutic response | Up to 24 Weeks |
| Kogarah |
| 2217 |
| Australia |
| Woodville | 5011 | Australia |
| Diepenbeek | 3590 | Belgium |
| Ghent | 9000 | Belgium |
| Liège | 4000 | Belgium |
| Winnipeg | Manitoba | R3A 1M4 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Montreal | Quebec | H2L 1S6 | Canada |
| Prague | 128 50 | Czechia |
| Leipzig | 04107 | Germany |
| Ratingen | 40882 | Germany |
| Wiesbaden | 65191 | Germany |
| Haifa | 31048 | Israel |
| Haifa | 34354 | Israel |
| Brescia | 25123 | Italy |
| Genova | 16132 | Italy |
| Modena | 41100 | Italy |
| Siena | 53100 | Italy |
| Leiden | 2333 ZA | Netherlands |
| Lublin | 20-022 | Poland |
| Poznan | 61-545 | Poland |
| Warsaw | 02-637 | Poland |
| Wroclaw | 50-556 | Poland |
| Guadalajara | 19002 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28046 | Spain |
| San Cristóbal de La Laguna | 38320 | Spain |
| Seville | 41014 | Spain |
| Cannock | WS11 5XY | United Kingdom |
| Leeds | LS1 3EX | United Kingdom |
| London | W1P 9PG | United Kingdom |
| Stoke-on-Trent | ST6 7AG | United Kingdom |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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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