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| ID | Type | Description | Link |
|---|---|---|---|
| 275-10-001 | Other Identifier | UCB |
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| Name | Class |
|---|---|
| UCB Japan Co. Ltd. | INDUSTRY |
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The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP870 group from Study 275-08-002 | Experimental | Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870 |
|
| CDP870 group from Study 275-08-004 | Experimental | Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP870 | Drug | Self-injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study | The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks. | |
| Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12 | at Week 12 | |
| Percentage of subjects who meet ACR20 criteria at Week 24 | at Week 24 | |
| Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12 | at Week 12 | |
| Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24 | at Week 24 | |
| Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12 | at Week 12 | |
| Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24 | at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| Fukuoka |
| Japan |
| Gunma | Japan |
| Hiroshima | Japan |
| Hokkaido | Japan |
| Hyōgo | Japan |
| Kagawa | Japan |
| Kagoshima | Japan |
| Kanagawa | Japan |
| Kumamoto | Japan |
| Nagasaki | Japan |
| Ōita | Japan |
| Saitama | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
| 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 |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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