UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009887
Receipt number R000011514
Scientific Title Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6
Date of disclosure of the study information 2013/04/01
Last modified on 2014/08/28 09:52:58

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Basic information

Public title

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Acronym

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Scientific Title

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Scientific Title:Acronym

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Region

Japan


Condition

Condition

Rheumatoid Arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Disease Activity Score-28 (DAS28-CRP/ESR)
Simplified Disease Activity Index (SDAI)
Clinical Disease Activity Index (CDAI)

Key secondary outcomes

Van der Heijde' modified Sharp score


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.

Interventions/Control_2

When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.

Interventions/Control_3


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. Patients with more than 20 years at the time of informed consent
2. Patients with oral methotrexate
3. Patients with informed consent

Key exclusion criteria

1. Patients with severe infectious disease
2. Patients with active tuberculosis
3. Patients with allergy to infliximab or mouse protein
4. Patients with demyelinated disease
5. Patients with congestive heart failure

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Okuno

Organization

Tohoku University Hospital

Division name

Department of Orthopaedic surgery

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, JAPAN

TEL

022-717-7245

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Okuno

Organization

Tohoku University Hospital

Division name

Orthopaedic surgery

Zip code


Address


TEL

022-717-7245

Homepage URL


Email

okuno@med.tohoku.ac.jp


Sponsor or person

Institute

Department of Orthopaedic surgery, Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

research fund of Orthopaedic surgery in Tohoku University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 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

Terminated

Date of protocol fixation

2013 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 28 Day

Last modified on

2014 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name