Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

This is a multi-center, randomized, active treatment controlled phase II study in patients with either new onset or therapy resistant rheumatoid arthritis (RA). This study will be conducted at 7 sites with NIAMS being the coordinating center and 6 external centers. Tripterygium wilfordii Hook F (TwHF) is a traditional medicinal plant that is and has been used in China for many years to treat inflammatory conditions including RA. This study we will be testing if a standardized plant extract from the roots of TwHF is superior to Sulfasalazine in improving the signs and symptoms in subjects with RA, as assessed by the ACR 20 criteria. Those subjects, who qualify for the study, will be allowed to continue on stable doses of NSAID therapy and/or low dose corticosteroids but will discontinue any DMARDs, or biologicals prior to the start of the study. Study subjects will then be randomized to receive either TwHF or Sulfasalazine and subjects will remain on double blind medication for 24 weeks. Patients will be assessed at baseline, 2 weeks and every 4 weeks thereafter using a standardized joint exam, questionnaires and laboratory measures for inflammation. ACR 20 responses will be calculated at each visit and compared in both groups at the end of evaluation at 24 weeks. Safety will be monitored throughout the trial. This is the first study that compares the extract of TwHF to a currently used DMARD in treating patients with RA and will help to define the role of new anti-inflammatory and possibly disease modifying agents in treating patients with RA.