Your search for tofacitinib returned 39 results

The GIDAC recommendations are provided to the FDA but they are not binding. The FDA has set a target PDUFA action date of June 2018.

The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.

The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen.  The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…

Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).

The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.

Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).

Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Pfizer announced top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib in the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

Patients treated with tofacitinib experienced significantly fewer disease flares compared with placebo.