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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011349-18 |
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This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folic acid | Drug | >/= 5 mg po weekly |
| |
| methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of TCZ after QW or Q2W sc administration | multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up | |
| Pharmacodynamic responses of CRP | sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment | |
| Safety and tolerability, including injection site reaction | laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy according to ACR and DAS-EULAR parameters | assessments on day 1 of weeks 1, 4, 8 and 12 | |
| PD responses of IL-6, sIL-6R and anti TCZ antibody | multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's | Newfoundland and Labrador | A1A 5E8 | Canada | |||
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D008727 | Methotrexate |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
7.5 - 25 mg weekly (oral or parenteral) |
|
| tocilizumab [RoActemra/Actemra] | Drug | 162 mg sc weekly (QW)for 12 weeks |
|
| tocilizumab [RoActemra/Actemra] | Drug | 162 mg sc every other week (Q2W) for 12 weeks |
|
| Kitchener |
| Ontario |
| N2M 5N6 |
| Canada |
| Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Christchurch | 8011 | New Zealand |
| A Coruña | La Coruña | 15006 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Seville | Sevilla | 41009 | Spain |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |