Tocilizumab for rheumatoid arthritis: results of the Phase III clinical trial program

2011 ◽  
Vol 1 (2) ◽  
pp. 345-354
Author(s):  
Javier Rueda ◽  
Miguel A González-Gay ◽  
Ricardo Blanco
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Clinical Trial Program

International multicenter randomized, placebo-controlled phase III clinical trial of β-d-mannuronic acid in rheumatoid arthritis patients

2019 ◽  
Vol 27 (5) ◽  
pp. 911-921 ◽  
Author(s):  
Zahra Rezaieyazdi ◽  
Abid Farooqi ◽  
Hossein Soleymani-Salehabadi ◽  
Arman Ahmadzadeh ◽  
Mona Aslani ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Mannuronic Acid ◽  
International Multicenter

scholarly journals Early non-response to certolizumab pegol in rheumatoid arthritis predicts treatment failure at one year. Data from a randomised phase III clinical trial

2018 ◽  
Vol 85 (1) ◽  
pp. 59-64 ◽  
Author(s):  
Francis Berenbaum ◽  
Thao Pham ◽  
Pascal Claudepierre ◽  
Thibault de Chalus ◽  
Jean-Michel Joubert ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Treatment Failure ◽  
Certolizumab Pegol ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
One Year

scholarly journals Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA

Bioanalysis ◽  
2020 ◽  
Vol 12 (19) ◽  
pp. 1363-1375
Author(s):  
Katrina M Nolan ◽  
Yuhua Zhang ◽  
Joseph M Antonello ◽  
Adrienne H Howlett ◽  
Cyrille J Bonhomme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conjugate Vaccine ◽  
Threshold Value ◽  
Phase Iii ◽  
Capsular Polysaccharides ◽  
Acceptance Criteria ◽  
Phase Iii Clinical Trial ◽  
Assay Validation ◽  
Clinical Trial Program

Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.

Sign in / Sign up

Export Citation Format

Share Document