Clinical Trials Logo

Clinical Trial Summary

This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial


Clinical Trial Description

Rheumatic polymyalgia (PMR) is more commonly observed in individuals over the age of 50, who may have a higher prevalence of osteoporosis, diabetes, cardiovascular diseases, and other chronic conditions. Currently, glucocorticoids are the primary treatment for PMR, but they can lead to various side effects, and recurrence is common during steroid tapering. Our previous 24-week study confirmed the effective treatment of PMR patients with tofacitinib. Given the relatively slow efficacy of tofacitinib, early adjunctive therapy with NSAIDs is needed. To address this, we are planning an open-label 52-week randomized controlled trial. This study aims to assess the use of tofacitinib in combination with glucocorticoids to induce rapid improvement, followed by rapid tapering of steroids and slow tapering of tofacitinib. The objective is to observe the efficacy and safety of this regimen for PMR, providing a new treatment option for clinical use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06172361
Study type Interventional
Source Zhejiang University
Contact Jinzhi Wu
Phone 8617817310616
Email wujinzhi1995@163.com
Status Not yet recruiting
Phase Phase 3
Start date January 15, 2024
Completion date January 30, 2026

See also
  Status Clinical Trial Phase
Terminated NCT04972968 - A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154 Phase 2
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Terminated NCT03600818 - Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica Phase 3
Completed NCT00836810 - Timed Release Tablet Prednisone in Polymyalgia Rheumatica Phase 2/Phase 3
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed NCT03263715 - A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE) Phase 3
Recruiting NCT05935709 - DANIsh VASculitis Database (DANIVAS)
Not yet recruiting NCT02985424 - Polymyalgia Rheumatica and Giant Cell Arteritis N/A
Completed NCT00138983 - Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Phase 3
Recruiting NCT06130540 - Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR Phase 1
Recruiting NCT05767034 - Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) Phase 3
Terminated NCT01821040 - A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR Phase 3
Recruiting NCT00982332 - Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica N/A
Recruiting NCT05312944 - Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome
Recruiting NCT04664465 - PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Withdrawn NCT02899026 - Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica Phase 3
Not yet recruiting NCT06281236 - A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) Phase 1
Recruiting NCT03576794 - Treatment With Leflunomide in Patients With Polymyalgia Rheumatica Phase 3
Completed NCT05681676 - Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients
Recruiting NCT05435781 - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency Phase 4