UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002421
Receipt number R000002954
Scientific Title Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis
Date of disclosure of the study information 2009/09/04
Last modified on 2013/09/03 11:42:14

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Basic information

Public title

Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis

Acronym

Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis

Scientific Title

Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis

Scientific Title:Acronym

Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis

Region

Japan


Condition

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of drug treatment, including biologics, on the suppression of AA amyloidosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of the amyloid deposition in the gastric biopsy specimen

Key secondary outcomes

Change of renal function
Serum creatinine, urinary protein, urinary creatinine, estimated creatinine clearance, cystatin C
Change of serum SAA
Change of diarrhea frequency
Change of DAS28-ESR


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

tocilizumab

Interventions/Control_2

Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab

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. Diagnosis of rheumatoid arthritis using the American College of Rheumatology classification criteria (1987)
2. Confirmation of the amyloid deposition by the tissue biopsy or diagnosis of "rheumatoid arthritis complicating AA amylidosis" in own institution
3. Patients who have the observational periods for about six months before starting the study
4. Patients must sign the informed consent

Key exclusion criteria

1. Pregnancy, lactation or planning pregnancy
2. Complicating severe infection
3. History of hypersensitivity to the treatment drug
4. Patients who are judged to be inappropriate by investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyuki Yoshizaki

Organization

Osaka University

Division name

Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering

Zip code


Address

Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka, Suita City, Osaka

TEL

06-6879-4738

Email

kyoshi@chem.eng.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuyuki Yoshizaki

Organization

Osaka University

Division name

Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering

Zip code


Address

Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka,

TEL

06-6879-4738

Homepage URL


Email

kyoshi@chem.eng.osaka-u.ac.jp


Sponsor or person

Institute

AA amyloidosis clinical research conference

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 09 Month 04 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

Enrolling by invitation

Date of protocol fixation

2008 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2008 Year 07 Month 01 Day

Last follow-up date

2012 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 09 Month 01 Day

Last modified on

2013 Year 09 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name