Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

Inclusion Criteria

• •Male and female outpatients between 18 and 75 years of age
• •Females must be of non-childbearing potential (post-menopausal, surgically sterilized or post hysterectomy) or using a double-barrier method of birth control for the duration of the study. A protocol acceptable method of double barrier method of birth control includes any combination of two or three of the following: condom, spermicidal and diaphragm.
• •Documented diagnosis of rheumatoid arthritis of at least six (6) months duration, as defined by the American Rheumatism Association 1987 Revised Criteria
• •American Rheumatism Association Functional Class I, II, or III
• •Meet the criteria for (active disease) at both screening and baseline visits by achieving all of the criteria below:
• •6 or more painful/tender joints
• •6 or more swollen joints
• •Visual Analog Scale (VAS) for pain of at least 3 (on scale of 1-10, where 1 is mild)
• •C-reactive protein (CRP) greater than or equal to 0.6 mg/dl or ESR greater than 25 mm/hr.
• •Prior/Current Therapy:
• •A. Subjects must be either DMARD or biological anti-RA agent naive or have failed a DMARD/biological RA agent, other than sulfasalazine, and have stopped this DMARD/biological one (1) month prior to randomization unless they have a flare in disease activity upon discontinuing DMARD/biological therapy as part of this protocol. DMARDs include but are not limited to methotrexate, leflunomide, minocycline, hydroxychloroquine, gold, cyclosporine, and biologics include anti-TNF and anti-IL-1 agents.
• •B. Subjects may be taking NSAIDs, provided the dose and frequency have been stable for 30 days prior to randomization. However if the patient meets the flare criteria they can be enrolled even if they have not fulfilled the criteria of being on a stable dose of NSAIDs and steroids for 30 days prior to randomization. At the time of flare neither steroids nor NSAIDs can be increased.
• •C. Subjects may be taking corticosteroid therapy equivalent to prednisone less than or equal to 7.5 mg/day. This dose must be stable for at least 1 month prior to randomization. Subjects may not change the dose of their corticosteroid or receive intra-articular or intra-muscular injections of corticosteroids, within 1 month of randomization or during the study. Note section 9.3 of the protocol, Concomitant Medication, has been amended to read: If it is medically necessary a one joint steroid injection is acceptable. This must be noted on the CRF and the joint excluded from the joint count.
• •D. Subjects may not be taking other complementary and/or alternative medications for RA for the last 1-month prior to randomization.
• •Subjects must provide written informed consent prior to any study-related screening tests.