Status:
COMPLETED
Tofacitinib as a GC Sparing Agent for Polymyalgia Rheumatica
Lead Sponsor:
RenJi Hospital
Conditions:
Polymyalgia Rheumatica
Effect of Drug
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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. ...
Detailed Description
A two-stage, phase 2 clinical trial was conducted to test whether tofacitinib would take into effect as a glucocorticoid sparing agent in patients with polymyalgia rheumatica. Tofacitinib was given at...
Eligibility Criteria
Inclusion
- Female or male between 50 and 85 years old.
- PMR according to the ACR/ EULAR 2012 PMR classification criteria.
- Patients must have erythrocyte sedimentation rate (ESR) ≥20 mm/hr and/or CRP ≥8 mg/L associated with highly active PMR (PMR-AS\>17) within 2 weeks prior to screening.
- Patient is willing and able to take prednisone of 15 mg/day at baseline.
- Signed written informed consent.
Exclusion
- 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 JAK 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 Any prior use of csDMARDs at unstable dose for less than 12 weeks before baseline, e.g. cyclosporine, azathioprine, mycophenolate mofetil, leflunomide, MTX; ⑥ Concurrent use of systemic GCs for conditions other than PMR.
- Evidence (as assessed by the investigators) of active infection, such as presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody in blood, human immunodeficiency virus (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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04799262
Start Date
January 1 2021
End Date
May 1 2022
Last Update
September 15 2022
Active Locations (1)
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1
Ren Ji Hospital
Shanghai, China, 201112