Kliniske studier

Sikkerhetsovervåkningsstudie

Oral Surveillance; Pasienter > 50 år med RA med minst en ytterliger kardiovaskulær risikofaktor
Steven R. Ytterberg, Deepak L. Bhatt, Ted R. Mikuls, Gary G. Koch, Roy Fleischmann, Jose L. Rivas,  Rebecca Germino, Sujatha Menon, Yanhui Sun, Cunshan Wang, Andrea B. Shapiro, Keith S. Kanik, and Carol A. Connell, for the ORAL Surveillance Investigators
Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis
N Engl J Med 2022;386:316-26

Revmatoid artritt

Oral Strategy; Xeljanz mono vs kombo vs adalimumab + MTX, MTX-IR
Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya L, Tatulych S, Mojcik C, Krishnaswami S, Menon S, Smolen JS; ORAL Strategy investigators
Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. 
The Lancet 2017; 390: 457–68

Oral Start; Xeljanz monoterapi, MTX naïve, radiografisk progresjon
Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators
Tofacitinib versus methotrexate in rheumatoid arthritis. 
N Engl J Med. 2014 Jun 19;370(25):2377-86

Oral Scan; Xeljanz med MTX i bakgrunn, MTX-IR, radiografisk progresjon 
van der Heijde D, Tanaka Y, Fleischmann R, Keystone E, Kremer J, Zerbini C, Cardiel MH, Cohen S, Nash P, Song YW, Tegzová D, Wyman BT, Gruben D, Benda B, Wallenstein G, Krishnaswami S, Zwillich SH, Bradley JD, Connell CA; ORAL Scan Investigators
Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. 
Arthritis Rheum. 2013 Mar;65(3):559-70

Oral Sync; Xeljanz med csDMARD i bakgrunn, csDMARDs/bDMARDs IR
Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J
Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. 
Ann Intern Med. 2013;159(4):253-261

Oral Step; Xeljanz med MTX i bakgrunn, anti-TNF-IR
Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators
Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. 
The Lancet 2013 Feb 9;381(9865):451-60

Oral Standard; Xeljanz med MTX i bakgrunn, MTX-IR
van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, García Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B; ORAL Standard Investigators
Tofacitinib or adalimumab versus placebo in rheumatoid arthritis.
N Engl J Med. 2012 Aug 9;367(6):508-19
 

Les mer om ORAL Standard-studien

Oral Solo; Xeljanz monoterapi, csDMARDs/bDMARDs IR
Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators
Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis.
N Engl J Med. 2012 Aug 9;367(6):495-507

Les mer om ORAL SOLO-studien