GCs Sparing Regimen in PMR

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Glucocorticoids are the cornerstone treatment for polymyalgia rheumatica but induce adverse events. The efficacy of the candidate drug tofacitinib has not yet been demonstrated in controlled studies. The aim of the study is to compare the efficacy and safety of tofacitinib as a glucocorticoid sparing agent in patients with refractory polymyalgia rheumatica.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Prednisone; Tofacitinib

Criteria

Inclusion Criteria:

• Female or male between 50 and 85 years.

• PMR according to the American College of Rheumatology (ACR)/European league Against Rheumatism (EULAR) 2012 PMR core (essential) classification criteria.

• Patients must have erythrocyte sedimentation rate ≥20 mm/hr and/or C-reactive protein ≥8 mg/L associated with PMR disease activity within 12 weeks prior to screening.

• Active PMR（PMR-AS>10) with prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day within 4 weeks of screening.

• For relapse: patient must have had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose of more than 5 mg/day (or equivalent) within the past 48 Weeks prior to screening.

• Patient is willing and able to take prednisone of 15 mg/day at randomization.

• Signed written informed consent.

Exclusion Criteria:

• Presence of any other connective tissue disease, such as but not limited to giant-cell arteritis, systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis.

• Concurrent diagnosis of active fibromyalgia, rhabdomyolysis or neuropathic muscular diseases.

• Organ transplant recipient.

• Any prior (within the defined period below) or concurrent use of immunosuppressive therapies but not limited to any of the following: (1) Any prior use of tumor necrosis factor inhibitors, anti-IL-6 agents or Janus kinase inhibitor; (2) Alkylating agents including cyclophosphamide within 6 months of baseline; (3) Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level; (4) Abatacept within 8 weeks of baseline; (5) Cyclosporine, azathioprine or mycophenolate mofetil or leflunomide within 4 weeks of baseline; (6) Unstable methotrexate (MTX) dose and/or MTX dose >15mg/week within 3 months of baseline; (7) Concurrent use of systemic GCs for conditions other than PMR.

• Evidence (as assessed by the investigator) of active infection, presence of hepatitis B surface antigen or hepatitis C antibody in blood, HIV positivity.

• Patients with a history of active or recurrent herpes zoster.

• Patients who have had surgery within 4 weeks of screening or planned surgery during study.

• Malignancy within 5 years prior to screening, except for non-melanoma skin cancer.

• Pregnant or breastfeeding woman.

• Any medical condition that could interfere with the implementation or interpretation of the study or with the safety of the patient during the study.