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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010813-57 | EudraCT Number |
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The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.
The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV | Experimental | Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV. |
|
| 1 mg/kg CDP6038 SC and Placebo SC | Experimental | Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc. |
|
| Optimized CDP6038 SC | Experimental | Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP6038 | Biological | Single dose: 1 mg/kg CDP6038 IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK/PD relationship between systemic CDP6038 exposure and CRP suppression. | For 12 weeks following single dose | |
| Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose | For 12 weeks following single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion | For 12 weeks following single dose | |
| Assess the immunogenicity of single dose CDP6038 | Multiple sampling from 0 to 12 weeks following single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duncansville | Pennsylvania | United States | ||||
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| CDP6038 |
| Biological |
Single dose: 0.1mg/kg CDP6038 IV |
|
| CDP6038 | Biological | Single dose: 1.0mg/kg CDP6038 SC |
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| Placebo IV | Other | Single dose: Placebo IV |
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| Placebo SC | Other | Single dose: Placebo SC |
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| CDP 6038 SC | Drug | Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo |
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| Methotrexate | Drug | Individual stable doses of methotrexate. |
|
| Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA | For 12 weeks following single dose |
| Dallas |
| Texas |
| United States |
| San Antonio | Texas | United States |
| Berlin | Germany |
| Cologne | Germany |
| Erlangen | Germany |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C000592400 | olokizumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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