Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs

• Published in: Arthritis & rheumatology (Hoboken, N.J.) Vol. 64; no. 3; pp. 617 - 629
• Main Authors: Fleischmann, Roy, Cutolo, Maurizio, Genovese, Mark C., Lee, Eun Bong, Kanik, Keith S., Sadis, Seth, Connell, Carol A., Gruben, David, Krishnaswami, Sriram, Wallenstein, Gene, Wilkinson, Bethanie E., Zwillich, Samuel H.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.03.2012; Wiley; Wiley Subscription Services, Inc
• Subjects: Adalimumab; Administration, Oral; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Diseases of the osteoarticular system; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Drug Substitution; Drug therapy; Drug Tolerance; Female; Health Status; Humans; Immunomodulators; Inflammatory joint diseases; Injections, Subcutaneous; Janus Kinase 3 - antagonists & inhibitors; Joints - drug effects; Joints - physiopathology; Male; Medical sciences; Methotrexate - therapeutic use; Middle Aged; Pharmacology. Drug treatments; Pilot Projects; Piperidines; Pyrimidines - administration & dosage; Pyrimidines - therapeutic use; Pyrroles - administration & dosage; Pyrroles - therapeutic use; Recovery of Function; Rheumatism; Rheumatoid arthritis; Human; Immunopathology; Diseases of the osteoarticular system; Antipsoriatic agent; Rheumatology; Oral administration; Autoimmune disease; Inflammatory joint disease; Immunomodulator; Chronic; Rheumatoid arthritis; Antirheumatic agent; Adalimumab; Dose; Comparative study

Objective To compare the efficacy, safety, and tolerability of 5 doses of oral tofacitinib (CP‐690,550) or adalimumab monotherapy with placebo for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response to disease‐modifying antirheumatic drugs. Methods In this 24‐we...