Rheumatic diseases
Conditions
Interventions
The 1g group: start TMP/SMX 1g (80 mg/400 mg)/day within 10 days of starting corticosteroid equivalent to/above 0.6 mg/kg/day of prednisolone, continue up to 24 weeks in principle. Continue or stop a
s decision.
The 0.5g group: start TMP/SMX 0.5g (40 mg/200 mg)/day within 10 days of starting corticosteroid equivalent to/above 0.6 mg/kg/day of prednisolone, continue up to 24 weeks in principle. Co
s decision.
The escalation group: start TMP/SMX 0.1g (8 mg/16 mg)/day within 10 days of starting corticosteroid equivalent to/above 0.6 mg/kg/day of prednisolone, increase dose by 0.1g in one week (a
Sponsors
Tokyo Medical and Dental University
Department of Pharmacovigilance, Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient with rheumatic disease starting corticosteroid equivalent to/above 0.6 mg/kg/day of prednisolone (with or without immunosuppressant) 2. A patient starting treatments mentioned above in a hospital setting 3. A patient who is 20 years old or more and gives written informed consent 4. A patient who has never used TMP/SMX, pentamidine nor diaphenylsulfone 5. A patient with serum creatinine less than maximum of normal range at registration
Exclusion criteria
Exclusion criteria: 1. When a patient refuses to give or withdraws his or her consent 2. When a patient has contraindications or contraindications in principle (see attachment 3) for TMP/SMX 3. When a patient uses biologics concomitantly 4. When a patient has a history of Pneumocystis pneumonia 5. When a patient has uncontrollable comorbidities (i.e., severe diabetes, unstable ischemic heart disease, stroke within the last 1 year) 6. When a patient's body weight is less than 40kg 7. When a patient is under breastfeeding or pregnant, or has a plan to be pregnant in 24 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCP prevention rate at 24 weeks of the 1g group (1g/day of TMP/SMX, the regular dose) and the escalation group (start 0.1g/day of TMP/SMX and increase gradually up to a half of the regular dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PCP prevention rate at 24 weeks of the 1g group and the 0.5g group (0.5g/day of TMP/SMX, a half of the regular dose) 2. PCP prevention rate at 24 weeks of the 0.5 g group and the escalation group 3. PCP prevention rate at 52 weeks of the 1g group, the 0.5g group and the escalation group 4. Withdrawal rates of TMP/SMX at 24 weeks and 52 weeks 5. Safety (incidence of adverse events and serious adverse events, side effects and contents of these severe side effects) 6. Situations of TMP/SMX administration up to 52 weeks | — |
Countries
Japan
Contacts
Public ContactKaori Watanabe
Tokyo Medical and Dental University Department of Pharmacovigilance, Department of Medicine and Rheumatology
Outcome results
None listed