Eligibility of Rheumatoid Arthritis Patients for a Phase 1b Clinical Trial Evaluating Turmeric Supplementation

• Published in: The FASEB journal 2017-04, Vol.31 (S1)
• Main Authors: Strom, Meghan, Alfafara, Chelsea, DeSalvo, Janel, McCallum, Mia, Hopkins, Laura, Pace, Thaddeus, Chow, Sherry, Levinsky, Dale, Ruderman, Eric, Billheimer, Dean, Funk, Janet
• Format: Article
• Language: English
• ISSN: 0892-6638; 1530-6860
• DOI: 10.1096/fasebj.31.1_supplement.lb353

Abstract only Rheumatoid arthritis (RA) is an autoimmune disease that primarily targets the joints, leading to synovial inflammation. Turmeric supplementation markedly reduces joint inflammation in pre‐clinical models of RA, suggesting a potential benefit in reducing joint inflammation in patients with RA. Here, we evaluate the percentage of patients eligible for a randomized controlled trial (RCT) of turmeric dietary supplements in RA, evaluating tolerability and pharmacokinetics. Recruitment materials were distributed in both rheumatology offices and community settings. Study entry eligibility criteria included having active disease (presence of inflamed and/or swollen joints), no current biologic use, as well as other health and medication criteria. Individuals were screened for basic eligibility through a telephone interview followed by a more comprehensive in‐clinic screening. In total, 200 patients were referred between September 2015 through October 2016; the majority (85%, n= 170) were self‐referred from community‐based recruitment strategies. From a pool of 171 (86%) who completed telephone screening, 40% (n=68) were disqualified from participation due to geographical location or having no clinical diagnosis of RA. Of the remaining 103 referrals, only 4% of local RA patients (n= 4) met all eligibility criteria; 15 (15%) discontinued the screening process and 84 (82%) were ineligible. Primary reasons for ineligibility included current or failed biologics (37%, n= 31) and no active disease (18%, n= 15). Other reasons included a serious comorbid medical condition (14%, n=12), unstable medication doses (13%, n= 11), high non‐steroidal anti‐inflammatory use (12%, n=10) or a history of malignancy (6%, n= 5). A greater proportion of patients referred from rheumatology practices passed telephone screening than those self‐referred from the community (20%, n= 6 vs. 8%, n= 14). Few of the patients screened met all eligibility requirements. Although uncommon, some patients did not wish to participate in the trial due to the possibility of receiving a placebo, as well as having to discontinue current turmeric supplement use. In summary, recruitment strategies that are primarily community‐based are inefficient in enrolling subjects who meet eligibility criteria for a RCT of turmeric dietary supplements in RA. Support or Funding Information NIH (NCCIH): R34AT007837‐03