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A phase 2B, randomized, double blind, placebo-controlled, multicenter study to compare 6 dose regimens of CP-690,550 vs. placebo, each combined with methotrexate, administered for 6 months in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone

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A phase 2B, randomized, double blind, placebo-controlled, multicenter study to compare 6 dose regimens of CP-690,550 vs. placebo, each combined with methotrexate, administered for 6 months in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Sep 2024

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At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Sponsors Pfizer

    • Most Recent Events

    • 14 Nov 2018 Results assessing Short-, Mid-, and Long-term Effects of Tofacitinib on Lymphocytes in RA patients using data from NCT00853385, NCT01039688, NCT00147498, NCT00413660, NCT00550446, CT02147587 and NCT00413699 sub-studies), published in the Arthritis and Rheumatology
    • 16 Jun 2018 Results of pooled data from 4 Phase 2 trials (NCT00413660; NCT00550446; NCT00603512; NCT00687193) and 5 Phase 3 randomised, double-blind, placebo-controlled trials (ORAL Scan [NCT00847613]; ORAL Solo [NCT00814307]; ORAL Sync [NCT00856544]; ORAL Standard [NCT00853385]; ORAL Step [NCT00960440]), were presented at the 19th Annual Congress of the European League Against Rheumatism.
    • 08 Nov 2017 Results (n=2673) of post-hoc analysis assessing the impact of inflammation severity at baseline on efficacy and safety of tofacitinib using pooled data from four phase II trials (NCT00413660, NCT00550446, NCT00603512, NCT00687193) and five phase III trials (ORAL Scan, ORAL Solo, ORAL Sync, ORAL Standard, ORAL Step), presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.

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