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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007727
Receipt No. R000009089
Scientific Title A randomized clinical trial on the efficacy and tolerability of dose reduction and escalation regimen of Trimethoprim/Sulfamethoxazole (TMP/SMX) in patients with rheumatic diseases
Date of disclosure of the study information 2012/04/20
Last modified on 2012/04/10

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Basic information
Public title A randomized clinical trial on the efficacy and tolerability of dose reduction and escalation regimen of Trimethoprim/Sulfamethoxazole (TMP/SMX) in patients with rheumatic diseases
Acronym A study on dose reduction and escalation regimen of TMP/SMX
Scientific Title A randomized clinical trial on the efficacy and tolerability of dose reduction and escalation regimen of Trimethoprim/Sulfamethoxazole (TMP/SMX) in patients with rheumatic diseases
Scientific Title:Acronym A study on dose reduction and escalation regimen of TMP/SMX
Region
Japan

Condition
Condition Rheumatic diseases
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we compare efficacy and tolerability between the dose-reduction-and-escalation regimen, the usual-dose regimen and the half-dose regimen of TMP/SMX given to rheumatic patients who start corticosteroid therapy.
Basic objectives2 Others
Basic objectives -Others Efficacy and tolerability
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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 after 24 weeks on doctor's decision.
Interventions/Control_2 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. Continue or stop after 24 weeks on doctor's decision.
Interventions/Control_3 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 (at least in 2 weeks). When it comes to 0.5g/day, continue it up to 24 weeks. Continue or stop after 24 weeks on doctor's decision.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 165

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayoshi Harigai
Organization Tokyo Medical and Dental University
Division name Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address 1-5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Watanabe
Organization Tokyo Medical and Dental University
Division name Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address 1-5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL 03-5803-4677
Homepage URL
Email watanabe.rheu@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pharmacovigilance, Tokyo Medical and Dental University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学・草加市立病院・東京都健康長寿医療センター・青梅市立総合病院・国家公務員東京共済病院・横浜市立みなと赤十字病院・武蔵野赤十字病院・熊本大学・島根大学・香川大学・産業医科大学
Tokyo medical and dental university, Soka municipal hospital, Tokyo metropolitan geriatric hospital, Ome municipal general hospital, Tokyo kyosai Hospital, Yokohama city minato red cross hospital, Musashino red cross hospital, Kumamoto university, Shimane university, Kagawa university, University of occupational and environmental health.

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2012 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 10 Day
Last modified on
2012 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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