Arthritis Advisory Committee
ACS Conference Room,
Chronic Gout
Conflict of Interest Statement Kimberly Littleton Topper, M.S.
Introduction and Overview of the topic: James P. Witter, MD, PhD
GENERAL AREAS FOR DISCUSSION
CHRONIC GOUT AND HYPERURICEMIA TRIAL DESIGN:
The appropriate design of trials
to demonstrate both efficacy and safety of new therapies for treatment of hyperuricemia associated with chronic gout is critical in
order to facilitate the development of useful products. The areas for discussion at this advisory committee meeting will include
the following:
1) Inclusion and exclusion criteria
a. baseline serum uric acid level
b. renal insufficiency
c. subjects with tophi
2) Trial duration
3) Placebo controlled trials vs non-inferiority trials
4) Concomitant medications
5) Choice of outcome measures:
a. serum uric acid levels
b. number of clinical exacerbations
Arthritis Advisory Committee
ACS Conference Room,
Acute Gout
Conflict of Interest Statement Kimberly Littleton Topper, M.S.
Introduction and Overview of the topic: Joel Schiffenbauer, MD
ACUTE
GOUT TRIAL DESIGN:
Individuals
with acute gout often experience significant pain. Therefore it is important to
carefully assess any new therapy for both efficacy and safety. However, there
have been a limited number of trials in this area. The areas for discussion
during this advisory committee meeting will include the following:
1) Inclusion and exclusion criteria:
a. polyarticular vs mono-articular gout
b. baseline pain
2) Placebo controlled trials vs non-inferiority trials
3) Duration of trials
4) Concomitant medications
5) Choice of outcome measures
a. methods to assess signs and symptoms