NCT00001261 - 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)

Dalakas M
Treatment of polymyositis and dermatomyositis. Curr Opin Rheumatol. 1989 Dec;1(4):443-9. Review.
Dalakas MC
Polymyositis, dermatomyositis and inclusion-body myositis. N Engl J Med. 1991 Nov 21;325(21):1487-98. Review.
Roifman CM, Schaffer FM, Wachsmuth SE, Murphy G, Gelfand EW
Reversal of chronic polymyositis following intravenous immune serum globulin therapy. JAMA. 1987 Jul 24-31;258(4):513-5.

The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over

Details for clinical trial NCT00001261

Clinical trial NCT00001261 - References