UMIN-CTR Clinical Trial

Public title

Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study

Acronym

"Bucillamine And Salazosulphapyridine In Combination therapy" study (BASIC study)

Scientific Title

Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study

Scientific Title:Acronym

"Bucillamine And Salazosulphapyridine In Combination therapy" study (BASIC study)

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate efficacy and safety of combination therapy with bucullamine and salazosulphapyridine, versus monotherapy of each drug.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Proportion of patients with "good response" according to EULAR three-category scale at months 6 and 12.

Key secondary outcomes

1)Proportion of patients with "moderate response" according to EULAR three-category scale at months 6 and 12.
2)Proportion of patients with "remission",defined as a DAS 28 of < 2.6 at months 6 and 12..
3)Change from baseline in the Sharp/ van der Heijde score at the end of study
4)Improvement of physical function (as measured by the change from baseline in the modified HAQ).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment)

Interventions/Control_2

Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment)

Interventions/Control_3

Combination therapy of bucillamine and salazosulphapyridine (over the study period)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Patients, fulfilled the ACR 1987 revised criteria for the classification of rheumatoid arthritis. (20-75 years old)
2)Outpatients (there are no schedules of hospitalization during a clinical trial period.)
3)Patients with active disease of <5 years'duration. Active disease as defined by the presence of >=3 tender and >= 3 swollen joints and with either CRP >=2.0mg/dl or ESR 30mm/hr.
4)Patients who can provide written informed consent by themselves.

Key exclusion criteria

[Complication]
Patients who had any of the following
diagnoses or medical history:
1)Autoimmune diseases such as systemic lupus erythematosus and malignancy.
2)Drug allergy
3)Severe heart, lung, liver, kidney and haematological disorders

[Treatment]
4)Patient who had received treatment with bucillamine or salazosulphapirydine
5)Patient who received intraarticular, intramuscular, or epidural injection of corticosteroids within 4 weeks prior to the entry or during the study.
Patients who received systemic coritosteroids with a dose of >10mg of prednisolone or patients whose cortico-steroid dose were changed within 4 weeks prior to the study entry or during the study. (except for patients who developed side effect related to corticosteroids)
6)Patient who received NSIADs with an overdosage or patients who had alterations in dose or usage of NSAIDs within 4 weeks prior to the study entry or during the study.

[Surgery]
7)Patients who had surgery for rheumatoid arthritis within 6 months prior to the study entry and during the study)
8)Patient who had the following treatment or procedure: plasma exchange, leukocyte -depleted therapy or arthrocentesis against affected joints within 4 weeks prior to the study entry or during the study.

[Others]
9)Patients who is in pregnancy, lactating, or with a possibility of the pregnancy and women who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study.
10)Patient who can not go to a hospital for check-up on a an appointed day.
11)Patient who participated other clinical trial program within 4 months prior to the study entry (including post-marketing clinical study)
12)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of the study.

Target sample size

180

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Suzuki

Organization

Tokai University medical school affiliated hospital

Division name

Department of Rheumatology

Zip code

Address

143 Shimokasuya, Isehara City, Kanagawa 259-1193, Japan

TEL

0453-92-1121

Email

Name of contact person

1st name
Middle name
Last name	Yasuo Suzuki

Organization

Tokai University medical school affiliated hospital

Division name

Department of Rheumatology

Zip code

Address

143 Shimokasuya, Isehara City, Kanagawa 259-1193, Japan

TEL

0453-92-1121

Homepage URL

Email

y3suzuki@is.icc.u-tokai.ac.jp

Institute

BASIC study group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2007

Year

09

Month

26

Day

Date of IRB

Anticipated trial start date

2007

Year

10

Month

01

Day

Last follow-up date

2010

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

09

Month

28

Day

Last modified on

2009

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001005