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This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 | Active Comparator |
| |
| Remicade | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK equivalence to remicade | PK sampling at week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy endpoint | -ACR criteria comparison with Baseline at Weeks 14,30,54 | up to week 54. |
| efficacy endpoint | - Time to onset of ACR20 response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Hyun Yoo | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32905628 | Derived | Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9. | |
| 27038608 | Derived | Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6. |
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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 |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Up to week 54. |
| efficacy endpoint | - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30 | Up to week 54. |
| efficacy endpoint | - Proportion of patients with a good response, defined according to the EULAR response criteria | Up to week 54. |
| efficacy endpoint | - ACR20 at weeks 14 and 54 | Up to week 54. |
| efficacy endpoint | - ACR50 and ACR70 at weeks 14, 30, and 54 | Up to week 54. |
| efficacy endpoint | - Hybrid ACR response at weeks 14, 30, and 54 | Up to week 54. |
| efficacy endpoint | - SDAI and CDAI at weeks 14, 30, and 54 | Up to week 54. |
| efficacy endpoint | - Joint damage progression at week 54 | Up to week 54. |
| efficacy endpoint | - SF-36 at weeks 14, 30, and 54 | Up to week 54. |
| efficacy endpoint | - Fatigue | Up to week 54. |
| efficacy endpoint | - Number of patients requiring salvage retreatment at weeks 30 and 54 | Up to week 54. |
| 23687260 | Derived | Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |