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This is a phase â…¢ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol | Other | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Drug | Certolizumab Pegol 200mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters. | Treatment will continue until the drug is commercially available in the country. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate. | Treatment will continue until the drug is commercially available in the country. | Up to 7 years |
| Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YoungMo Kang, MD, PhD | Kyungpook National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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Treatment will continue until the drug is commercially available in the country. |
| Up to 7 years |
| To assess the achievement of clinical remission measured by DAS28. | Treatment will continue until the drug is commercially available in the country. | Up to 7 years |
| The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). | Treatment will continue until the drug is commercially available in the country. | Up to 7 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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 |