The purpose of this phase II clinical trial was to examine safety of elk velvet antler taken concurrently with rheumatoid arthritis medications and to determine efficacy by dose to enable sample size estimation and dose standardization for a larger study. Forty patients with stage II rheumatoid arthritis were randomly assigned to 1 of 4 arms of 10 patients each. One group received placebo and the other 3 groups received 2, 4, or 6 capsules (215 mg) of elk velvet antler with appropriate placebos to total 6 capsules daily. All subjects continued to take their arthritis medications. Outcome variables were reported adverse events and health status. At 1 month, there were no significant differences between groups in number of adverse events or health status. The greatest improvement was in the 6 elk velvet antler group, the least was in the placebo group. Differences were not statistically significant. It was concluded that elk velvet antler can be taken safely in conjunction with a number of rheumatoid arthritis medications and should be studied further to assess efficacy.