1. Male or non-pregnant, non-lactating female patients of any race with an age >18 years. Woman of child-bearing potential must be on regular contraceptives throughout the trial (Pregnancy tests).
1A: RA according to the 1987 revised ARA criteria (Arnett 1987) with an active disease with DAS28>3.2 despite the prior or concurrent use of DMARDs.
2. Patients may be on no active therapy or may be on continuous DMARD therapy including Methotrexate, Sulphasalazine, Leflunomide, Hydroxychloroquine, Myocrisin alone or in combination, or on NSAID treatment, or on steroid (prednisolone not more than 10mg/day).
3. Patients must have a measurable acute phase response: CRP (> 10mg/dl), ESR > 25. (to be measured on routine lab range CRP/ ESR/AP/ standard biochemistry)
4. Patients eligible for treatment with biological TNFα blockers and who are awaiting the administration of such treatment may enroll in the laboratory and safety protocols Data for Clinical Phase observations will be collected but will be handled as last observation carried forward for the final records prior to the administration of TNF blocking agent, should that occur within the 3-month Clinical Phase. The administration of TNFα blockers will not be delayed for the protocol.
5. Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
Read more: http://www.clinicaltrials.gov/ct2/show/NCT01416493?cond=%22Arthritis%22&lup_s=07/28/2011&lup_d=30
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