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Early warning model and innovative prevention regimen for reactivation of tuberculosis infection in patients with rheumatic diseases

Early warning model and innovative prevention regimen for reactivation of tuberculosis infection in patients with rheumatic diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072780
Enrollment
Unknown
Registered
2023-06-25
Start date
2023-06-25
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberculosis infection of patients with rheumatic diseases

Interventions

HP (6w) Group :Isoniazid (600mg, biw) and rifapentine (600mg, biw) for 6 weeks
Modified 3HP (12 weeks) Group:Isoniazid (300mg, qd) and rifapentine (450mg, biw) for 12 weeks

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Diagnosed with any types of rheumatic disease; (2) Aged = 18 years old; (3) Medication meet any of the following requirements: ? Currently treated with glucocorticoids at a dosage equivalent to 15mg prednisone daily or more; ? Using any of the following immunosupressants: methotrexate, cyclophosphamide, mycophenolate mofetil, cyclosporine A, azathioprine, tacrolimus, leflunomide, iguratimod, tripterygium glycosides; ? Preparing to use any of following biologics: etanercept, infliximab, adalimumab, golimumab, beritan, telitacicept, tofacitinib, baricitinib; (4) There is currently no evidence of active tuberculosis or suspected active tuberculosis; (5) No history of anti-tuberculosis treatment in the past 2 years; (6) Positive results of IGRAs.

Exclusion criteria

Exclusion criteria: (1) Combined with malignant tumors; (2) Accompanied by severe organ failure; (3) Patients whose expected survival time is less than 1 year; (4) HIV-positive; (5) History of Isoniazid or Rifapentine allergy; (6) Women during pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Drug discontinuation rate due to serious adverse events or tuberculosis reactivation;Incidence of active tuberculosis;

Secondary

MeasureTime frame
Incidence of tolerable adverse events;Drug compliance;

Countries

P.R.China

Contacts

Public ContactXiaoqing Liu

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

liuxq@pumch.cn+86 139 1176 1571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026