UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029056 |
|---|---|
| Receipt number | R000032915 |
| Scientific Title | Actemra, Long-Term Special Drug Use Surveillance in Takayasu arteritis and Giant cell arteritis patients |
| Date of disclosure of the study information | 2017/09/13 |
| Last modified on | 2023/10/03 16:24:44 |
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Basic information
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
Condition
Takayasu arteritis, Giant cell arteritis
Classification by specialty
| Medicine in general | Cardiology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
nomuramkt@chugai-pharm.co.jp
Public contact
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
shimizuayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2017 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
https://doi.org/10.1093/mr/roac099 https://doi.org/10.1093/mr/road074
Publication of results
Published
Result
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
Progress
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
Other related information
Adverse events
Corticosteroid, Cinical features,relapse rate
Management information
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
