Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Summary

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Timeline

Start

2013-04

Primary completion

2015-03

Completion

2015-03

Publications

• Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x.
• Norton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.
• Deodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198.
• Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
• Magrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5.
• Ostergaard M, Wu J, Fallon L, Sherlock SP, Wang C, Fleishaker D, Kanik KS, Maksymowych WP. Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial. Rheumatol Ther. 2023 Aug;10(4):1001-1020. doi: 10.1007/s40744-023-00564-y. Epub 2023 Jun 18.
• Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.
• van der Heijde D, Deodhar A, Wei JC, Drescher E, Fleishaker D, Hendrikx T, Li D, Menon S, Kanik KS. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-1347. doi: 10.1136/annrheumdis-2016-210322. Epub 2017 Jan 27.

Drugs

Indications