NCT00001677 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Davis JC Jr, Fessler BJ, Tassiulas IO, McInnes IB, Yarboro CH, Pillemer S, Wilder R, Fleisher TA, Klippel JH, Boumpas DT
High dose versus low dose fludarabine in the treatment of patients with severe refractory rheumatoid arthritis. J Rheumatol. 1998 Sep;25(9):1694-704.
Priebe T, Platsoucas CD, Seki H, Fox FE, Nelson JA
Purine nucleoside modulation of functions of human lymphocytes. Cell Immunol. 1990 Sep;129(2):321-8.

Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy

Clinical trial NCT00001677 - References