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| ID | Type | Description | Link |
|---|---|---|---|
| JNS012-JPN-03 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNTO 148 50 mg + methotrexate | Experimental |
| |
| CNTO 148 100 mg + methotrexate | Experimental |
| |
| Placebo + methotrexate | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 148 | Drug | 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR 20% response | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire) | Week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asahi | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22121129 | Derived | Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-FORTH Study Group. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012 Jun;71(6):817-24. doi: 10.1136/ard.2011.200317. Epub 2011 Nov 25. |
| Label | URL |
|---|---|
| A Study of Golimumab (CNTO 148) Administered in Combination with Methotrexate (MTX) in Patients with Active Rheumatoid Arthritis | View source |
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| Placebo | Drug | Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24. |
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| Methotrexate (MTX) | Drug | 6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52. |
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| Asahikawa |
| Japan |
| Azumino | Japan |
| Chiba | Japan |
| Fukui | Japan |
| Fukuoka | Japan |
| Fukushima | Japan |
| Gifu | Japan |
| Goshogawara | Japan |
| Hachiōji | Japan |
| Hamamatsu | Japan |
| Higashi-Hiroshima | Japan |
| Hiki | Japan |
| Hiroshima | Japan |
| Hitachi | Japan |
| Iruma | Japan |
| Izumisano | Japan |
| Izumo | Japan |
| Kamakura | Japan |
| Katō | Japan |
| Kawachi-Nagano | Japan |
| Kawagoe | Japan |
| Kawasaki | Japan |
| Kita-Gun | Japan |
| Kitakyushu | Japan |
| Kitamoto | Japan |
| Kobe | Japan |
| Kumamoto | Japan |
| Kyoto | Japan |
| Matsue | Japan |
| Matsumoto | Japan |
| Matsuyama | Japan |
| Nagano | Japan |
| Nagasaki | Japan |
| Nagoya | Japan |
| Narashino | Japan |
| Nishinomiya | Japan |
| Ohta-Ku | Japan |
| Osaka | Japan |
| Ōita | Japan |
| Ōsaki | Japan |
| Sagamihara | Japan |
| Saitama | Japan |
| Sapporo | Japan |
| Sasebo | Japan |
| Sendai | Japan |
| Shimotsuga | Japan |
| Shimotsuke | Japan |
| Shinjuku | Japan |
| Shinjuku-Ku | Japan |
| Shizuoka | Japan |
| Suita | Japan |
| Tokorozawa | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
| Toshima-Ku | Japan |
| Toyama | Japan |
| Toyoake | Japan |
| Toyohashi | Japan |
| Tsu | Japan |
| Tsukuba | Japan |
| Tsukubo | Japan |
| Ube | Japan |
| Yokohama | Japan |
| Yufu | 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 |
|---|---|
| C529000 | golimumab |
| 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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