ASTELLAS-015K-CL-RA21

Study Sponsor: Astellas

Study Title

A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients who have had an Inadequate Response to Methotrexate

Medicine or Vaccine (generic name)

peficitinib hydrobromide

Sponsor Identification Number

015K-CL-RA21

Trial Registry Identification Number(#'s)

NCT01554696
EudraCT 2011-006018-15

Medical Condition

Rheumatoid Arthritis

Phase

Phase 2

Link to Astellas Study Register

https://www.clinicaltrials.astellas.com/study/?pid=015K-CL-RA21

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT01554696

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-006018-15

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

February 2020