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The feasibility study of accelated infliximab infusion during maintenance phase

The feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007806
Enrollment
54
Registered
2012-05-01
Start date
2012-06-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn&#39

Interventions

Sponsors

Chiba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)infliximab-maintenance treatment adequate case, who are already successfully administrated with usual 2hr infuion without infusion reaction at three and more initial treatment. 2)Adequate organ fanction, no hematological disorder 3)Written informed consent

Exclusion criteria

Exclusion criteria: 1)active serious infection 2)active tuberuculosis infection 3)past history of bronchial asthma 4)past history of hypersensitivity reaction and/or allergy for any drugs and food 5)allergy and/or hypersensitivity for mouse-derived protein 6)demyelinating disease(MS) 7)congestive heart failure 8)pregnant, nursing or likelihood of pregnancy woman 9)unable to birth control during and after 6 months from the latest infliximab administration 10)past treatment history with infliximab and readministration at an interval of over three months 11)Not suitable for participating in the study for any other reason

Design outcomes

Primary

MeasureTime frame
The incidence of infusion reaction with 60min infliximab accelated infusion

Secondary

MeasureTime frame
1) patients preference 2) discontinuous rate due to infusion reaction 3) success rate of rescue by usual 2hrs infusion after occurrence of infusion reaction 4) evaluation of premedication

Countries

Japan

Contacts

Public ContactEmiko Sakaida

Graduate School of Medicine, Chiba University Department of Medical Oncology

esakaida@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026