UMIN-CTR Clinical Trial

Public title

Actemra, Long-Term Special Drug Use Surveillance in Takayasu arteritis and Giant cell arteritis patients

Acronym

Actemra, Long-Term Special Drug Use Surveillance in TAK/GCA patients

Scientific Title

Actemra, Long-Term Special Drug Use Surveillance in Takayasu arteritis and Giant cell arteritis patients

Scientific Title:Acronym

Actemra, Long-Term Special Drug Use Surveillance in TAK/GCA patients

Region

Japan

Condition

Takayasu arteritis, Giant cell arteritis

Classification by specialty

Medicine in general	Cardiology	Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To ascertain the safety and effectiveness of Actemra for subcutaneous injection in post-marketing use for patients with takayasu arteritis and giant cell arteritis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of adverse events and adverse drug reactions
Daily fluctuation of corticosteroid
Changes in clinical features of TAK/GCA
Rate of relapse, etc.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have no medical history of Actemra SC and IV for TAK or GCA for the last 6 months.

Key exclusion criteria

No criteria

Target sample size

240

Name of lead principal investigator

1st name	Makoto
Middle name
Last name	Nomura

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Real World Data Science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3273-0769

Email

nomuramkt@chugai-pharm.co.jp

Name of contact person

1st name	Ayaka
Middle name
Last name	Shimizu

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Real World Data Science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3273-0905

Homepage URL

Email

shimizuayk@chugai-pharm.co.jp

Institute

Chugai Pharmaceutical Co. Ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

None

Address

None

Tel

None

Email

None

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

2017

Year

09

Month

13

Day

URL releasing protocol

https://doi.org/10.1093/mr/roac099 https://doi.org/10.1093/mr/road074

Publication of results

Published

URL related to results and publications

https://doi.org/10.1093/mr/roac099 https://doi.org/10.1093/mr/road074

Number of participants that the trial has enrolled

132

Results

GCA
Of the 117 patients 38.5% reported adverse events
The most common adverse events of special interest were neutropaenia and leukopaenia 7.7% followed by serious infection 6.0%
The relapse-free proportion was 85.0%; relapse after remission 6.0% and no remission 9.0%
At the last observation, 94.2% of relapse-free patients received a concomitant glucocorticoid dose of under 10 mg per day
Fatigue headache neck pain and absence of LVLs were positively associated with the relapse etc

Results date posted

2023

Year

10

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

TAK
Patients with TAK who did not receive tocilizumab in the 6months immediately before registration and were scheduled to receive the drug during the enrolment period were eligible for inclusion in the study.

GCA
Patients with GCA who did not receive TCZ treatment for at least 6months before study initiation were included.

Participant flow

TAK and GCA
A multicentre prospective phase 4 large-scale observational study

Adverse events

TAK
AEs were reported in 40.8% of patients included in the safety analysis. The most common AEs, reported in more than 2.0% of patients, were nasopharyngitis, followed by gastroenteritis, back pain, and malaise, each reported in 2.5% of patients. Serious AEs were observed in 15.8% of patients; 1.7% of patients reported pneumonia as an SAE.

GCA
AEs were reported in 38.5% of patients included in the safety analysis. The most common AEs more than 2% of patients were leukopaenia, followed by abnormal hepatic function and upper respiratory tract inflammation. Serious AEs occurred in 17.9% of patients, with the most common SAEs more than 1% of patients, being leukopaenia and pneumonia. No deaths or ocular AEs were reported.

Outcome measures

TAK
Change in clinical features of TAK: Fever, neck pain, chest and back pain, headache, fatigue, and breathlessness were observed at baseline but resolved at the post-treatment observation in 4, 24, 15, 13, 37, and 10 patients, respectively.
Proportion of patients with relapse and findings associated with relapse: Relapse until the last observation was seen in 20.0% of patients, resulting in a relapse-free proportion of 80.0%. Until the last observation, 0.8%, 2.5%, and 16.7% of patients reported more than 3, 2, and 1 relapse, respectively.

GCA
Change in clinical features of GCA: Of the 103 patients in the clinical features analysis set, fever resolved in two of two patients each; neck pain in 18 of 20 patients; chest and back pain in four of five patients; headache in 28 of 32 patients; fatigue in 42 of 45 patients; and breathlessness in two of two patients following TCZ treatment. One patient developed fatigue after TCZ treatment, which was not observed at baseline. As the attending physician considered this patient to have relapsed GCA, the glucocorticoid dose was increased.
Proportion of patients with relapse and findings associated with relapse: Of the 101 patients in the relapse analysis set, 85.0% reached a relapse-free status after achieving remission, 6.0% relapsed, and 9.0% did not achieve remission after treatment until the last observation point.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

24

Day

Date of IRB

2017

Year

08

Month

24

Day

Anticipated trial start date

2017

Year

09

Month

19

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Adverse events
Corticosteroid, Cinical features,relapse rate

Registered date

2017

Year

09

Month

08

Day

Last modified on

2023

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032915