Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223004

Enrollment

1332

Registered

2015-11-04

Start date

2015-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis

Interventions

investigational material(s) Generic name etc : Copaxone subcutaneous injection syringe INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients treated with Copaxone from the first day of market launch of the product

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Percentage of participants who had one or more adverse events Timeframe; Up to 24 months Annual relapse rate (ARR) The annual relapse rate (ARR) after the start of treatment will be calculated throughout study. Timeframe; Up to 24 months	—

Secondary

Measure	Time frame
Changes in the number of lesions from brain MRI findings Timeframe; Up to 24 months Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS]) EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. EDSS scale ranges from 0 to 10 in 0.5 unit increments and higher score refers to people with higher levels of disability by multiple sclerosis. Timeframe; Up to 24 months Changes in functional evaluation scores (Functional Systems [FS]) FS is based on a standard neurological examination; the 7 functional systems plus "other" (Pyramidal, Cerebellar, Brainstem, Sensory, Bowel and bladder function, Visual function, Cerebral [or mental] functions, other) are rated. Each FS is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability), and total score ranging from 0 to 40. Higher score in each functional system refers to people with higher levels of disability by multiple sclerosis. Timeframe; Up to 24 months	—

Measure

Time frame

Changes in the number of lesions from brain MRI findings Timeframe; Up to 24 months Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS]) EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. EDSS scale ranges from 0 to 10 in 0.5 unit increments and higher score refers to people with higher levels of disability by multiple sclerosis. Timeframe; Up to 24 months Changes in functional evaluation scores (Functional Systems [FS]) FS is based on a standard neurological examination; the 7 functional systems plus "other" (Pyramidal, Cerebellar, Brainstem, Sensory, Bowel and bladder function, Visual function, Cerebral [or mental] functions, other) are rated. Each FS is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability), and total score ranging from 0 to 40. Higher score in each functional system refers to people with higher levels of disability by multiple sclerosis. Timeframe; Up to 24 months

—

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

smb.Japanclinicalstudydisclosure@takeda.com+81-6-6204-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026