NCT00034060 - 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)

Gabriel SE, Crowson CS, O'Fallon WM
Mortality in rheumatoid arthritis: have we made an impact in 4 decades? J Rheumatol. 1999 Dec;26(12):2529-33.
Mancia D, Lechi A, Terzano MG, Gemignani F, Vigouroux PR, Naquet R
[Electrophysiological criteria and prognostic evaluation in prolonged post-traumatic coma. Joint study of 150 cases]. Riv Neurol. 1975 Jan-Mar;45(1):44-59. Italian.
Straub RH, Cutolo M
Involvement of the hypothalamic--pituitary--adrenal/gonadal axis and the peripheral nervous system in rheumatoid arthritis: viewpoint based on a systemic pathogenetic role. Arthritis Rheum. 2001 Mar;44(3):493-507. Review.

Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis

Clinical trial NCT00034060 - References