tuberculosis infection of patients with rheumatic diseases
Conditions
Interventions
INH (9m) group:oral isoniazid for 9 months
INH+RFT (3m) group:oral isoniazid and rifapentine for 3 months
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years; 2. Diagnosed with rheumatic diseases including systemic lupus erythematosus (SLE), Takayasu arthritis (TA), Behcets disease (BD), primary Sjogrens syndrome (pSS), Rheumatoid arthritis (RA) and ankylosing spondylitis (AS); 3. Currently treated without biologics; 4. Medication met any of the following requirements: (1) Currently treated with glucocorticoids at a dosage equivalent to 15mg prednisone daily or more; (2) Using any of the following immunosupressants: methotrexate (MTX), cyclophosphamide (CTX), mycophenolate mofetil (MMF), cyclosporin A (CsA), azathioprine (AZA), tacrolimus (FK506), leflunomide (LEF), iguratimod and Tripterygium Wilfordii hook f (T2WF); (3) Preparing to use any of following biologics: etanercept (ETN), infliximab (IFX), adalimumab (ADA) and golimumab (GOL); 5. LTBI status diagnosed using T-SPOT.TB (T-SPOT.TB >= 24 SFCs/106PBMC) The study was affected by slow enrollment disruptions due to the Covid-19 pandemic. In order to accelerate the process of recruitment, it was decided that patients being diagnosed as RA or AS and patients who were planning to use biologics including ETN, IFN, ADA and GOL were also eligible for recruitment on an expert consultation meeting held on April 8th, 2020. Both WHO guidelines and Chinese expert consensus recommended that LTBI should be screened and preventively treated before initiation of TNF inhibitors. However, RCTs evaluating the efficacy and safety of short-course treatment regimens to prevent TB was still lacking in China. Therefore, inclusion of this group of patients was of clinical significance and met ethical requirement. Patient enrollment was completed on August 13rd, 2021.
Exclusion criteria
Exclusion criteria: 1. Diagnosed or suspected of active tuberculosis at present; 2. HIV-positive; 3. HBsAg(+) or HCV-Ab(+) or hepatic cirrhosis; 4. Hepatic dysfunction: total bilirubin >n3mg/dL, AST or ALT higher than 2 folds of normal upper limit value; 5. History of receiving preventive anti-tuberculosis treatment; 6. History of Isoniazid or Rifapentine allergy; 7. Women during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of active tuberculosis;Drug discontinuation rate due to serious adverse events or tuberculosis activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of tolerable adverse events;Drug compliance; | — |
Countries
China
Contacts
Public ContactXiaoqing Liu
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed