What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Diet 1, or Diet 2. The registry lists allocation as randomized. In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet.
They plan to enroll about 124 people at La Jolla. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
Interventions: Diet 1, Diet 2
Primary outcome (registry wording): Decrease of more than 5 points in Clinical Disease Activity Index