FDA guidance on design and conduct for RA trials
| Claim | Duration | End point(s) |
|---|---|---|
| AIMS, Arthritis Impact Measurement Scales; ACR, American College of Rheumatology; FDA, Food and Drug Administration; HAQ, Health Assessment Questionnaire; NSAID, non-steroidal anti-inflammatory drug; RA, rheumatoid arthritis. | ||
| Reduction in signs and symptoms of RA | ≥6 Months or 3 months if the product belongs to an already well characterised pharmacological class (e.g., NSAIDs) | Composite end points, such as ACR 20 or Paulus criteria (1990), or well accepted signs/symptoms measures (i.e., joint pain, tenderness, and swelling, using a 66 or 28 joint count, and global assessments |
| Major clinical response | ≥7 Months | ACR 70 for 6 consecutive months |
| Complete clinical response | ≥1 Year | Remission by ACR criteria and radiographic arrest by Larsen or modified Sharp method for 6 consecutive months |
| Remission | ≥1 Year | Remission by ACR criteria and radiographic arrest by Larsen or modified Sharp method for >6 consecutive months while not receiving any antirheumatic treatment |
| Prevention of disability | 2–5 Years | HAQ or AIMS and SF-36 in addition to demonstration of improvement of signs and symptoms |
| Prevention of structural damage | 1 Year | Slowing x ray progression using either Larsen or Modified Sharp, or other validated radiographic index in addition to one of the other claims |