drugset / Trial / NCT02795299
Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis
Phase 2
Withdrawn
Bird Rock Bio, Inc.
Pharmagenix · collabTechtrials Pesquisa e Tecnologia Ltda · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Phase 2 Study Evaluating Gerilimzumab's Safety/Efficacy for Patients with an Inadequate Response to MTX or a TNFα Antagonist in Rheumatoid Arthritis.
Timeline
- Start
- 2018-01
- Primary completion
- 2019-05
- Completion
- 2019-09
Publications
- Results Pereira IA, Mota LM, Cruz BA, Brenol CV, Fronza LS, Bertolo MB, Freitas MV, Silva NA, Louzada-Junior P, Giorgi RD, Lima RA, Pinheiro Gda R; Brazilian Society of Rheumatology. 2012 Brazilian Society of Rheumatology Consensus on the management of comorbidities in patients with rheumatoid arthritis. Rev Bras Reumatol. 2012 Aug;52(4):474-95. English, Portuguese.
- Results McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.
- Results Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014 Sep;73(9):1616-25. doi: 10.1136/annrheumdis-2013-205137. Epub 2014 Apr 3.
- Results Mease P, Strand V, Shalamberidze L, Dimic A, Raskina T, Xu LA, Liu Y, Smith J. A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate. Ann Rheum Dis. 2012 Jul;71(7):1183-9. doi: 10.1136/annrheumdis-2011-200704. Epub 2012 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gerilimzumab | Unknown | 2 mg | Subcutaneous |
| Comparator | Gerilimzumab | Unknown | 5 mg | Subcutaneous |
| Comparator | Gerilimzumab | Unknown | 10 mg | Subcutaneous |
| Comparator | Methotrexate | Small molecule | 15 mg | Oral |
| Comparator | Methotrexate | Small molecule | 25 mg | Oral |
| Comparator | folic acid | Other / unclassified | 1 mg | — |