A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Santarus Clinical Investigational Site 1012
Phoenix, Arizona, United States
Santarus Clinical Investigational Site 1004
El Cajon, California, United States
Santarus Clinical Investigational Site 1008
Number of Participants With Adverse Events
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
Time frame: 10 weeks
Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.
Time frame: Baseline, End of Treatment Visit (Week 7)
Number of Participants With American College of Rheumatology 20 (ACR20) Response.
A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following: * Swollen joint count (66 joints) * Tender joint count (68 joints) and * At least three of the following five assessments: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Patient's assessment of physical function, as measured by the HAQ-DI * CRP
Time frame: End of Treatment Visit (Week 7)
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Los Angeles, California, United States
Santarus Clinical Investigational Site 1011
San Leandro, California, United States
Santarus Clinical Investigational Site 1013
Brandon, Florida, United States
Santarus Clinical Investigational Site 1003
Palm Harbor, Florida, United States
Santarus Clinical Investigational Site 1017
Florissant, Missouri, United States
Santarus Clinical Investigational Site 1009
Brooklyn, New York, United States
Santarus Clinical Investigational Site 1019
Chapel Hill, North Carolina, United States
Santarus Clinical Investigational Site 1014
Charlotte, North Carolina, United States
...and 2 more locations