Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005502-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab, MTX, folic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab, MTX, folic acid | Drug | Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring | Efficacy will be assessed by evaluation of ACR criteria (ACR 20% , ACR 50% , ACR 70%, and hybrid ACR response), Safety will be assessed by evaluation of hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and body temperature),etc,. | 8 week interval |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| DaeHyun Yoo, Ph.D | Hanyang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University College of Medicine Hospital | Incheon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28600696 | Derived | Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |