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Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | subcutaneous administration of placebo given for 12 weeks |
|
| One Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol |
|
| Second Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol |
|
| Third Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol |
|
| Fourth Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol |
|
| Fifth Dose | Experimental | BG9924 - dosage level administered as per Biogen Idec protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baminercept alfa 1 | Biological | experimental - one dose level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of BG9924 in this participant population | 3 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coordinating Research Site | San Miguel de Tucumán | T4000AXL | Argentina | |||
| Coordinating Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25405351 | Derived | Bienkowska J, Allaire N, Thai A, Goyal J, Plavina T, Nirula A, Weaver M, Newman C, Petri M, Beckman E, Browning JL. Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis. PLoS One. 2014 Nov 18;9(11):e112545. doi: 10.1371/journal.pone.0112545. eCollection 2014. |
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|
| Placebo | Biological | Placebo comparator |
|
|
| Baminercept alfa 2 | Biological | experimental - second dose level |
|
|
| Baminercept alfa 3 | Biological | experimental - third dose level |
|
|
| Baminercept alfa 4 | Biological | experimental - fourth dose level |
|
|
| Baminercept alfa 5 | Biological | experimental - fifth dose level |
|
|
| São Paulo |
| 04027-000 |
| Brazil |
| Coordinating Research Site | Budapest | H2143 | Hungary |
| Coordinating Research Site | Cuernavaca | 62270 | Mexico |
| Coordinating Research Site | Torun | 87100 | Poland |
| Coordinating Research Site | Brăila | 810112 | Romania |
| Coordinating Research Site | Moscow | 115522 | Russia |
| Coordinating Research Site | Leeds | Yorkshire | LS7 4SA | United Kingdom |
| 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 |
|---|---|
| D053308 | Lymphotoxin-beta |
| ID | Term |
|---|---|
| D048069 | Tumor Necrosis Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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