Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis (CARAT-1)
The purpose of this study is to evaluate the safety and tolerability of multiple oral doses of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis|
- Subject Incidence of Adverse Events [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
- Evaluate possible interaction with methotrexate at a number of dose levels in subjects with stable RA [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: CCX 354-C
This randomized, double-blind, placebo-controlled Phase I/II study will consist of two sequential stages, Stage A and B. This protocol describes the objectives, design, and procedures for Stage A of the study. The protocol will be amended in future when sufficient data from Stage A have been collected to initiate Stage B. The protocol amendment will describe the objectives, design, and procedures for Stage B of the study.
Stage A will be a randomized, double-blind, placebo-controlled, multi-dose, sequential dose escalation sub-study in 24 subjects with stable RA. Three sequential dose cohorts of 8 subjects will be included in this stage:
- Cohort 1: 100 mg CCX354-C or placebo
- Cohort 2: 100 mg CCX354-C or placebo
- Cohort 3: 200 mg CCX354-C or placebo
Safety and PK data from each cohort will be reviewed by a data monitoring committee (DMC)before dose escalation to the next dose level. The study will proceed to Stage B only if the safety and tolerability profile of Stage A is deemed acceptable by the DMC.