## Protocol Section
### Identification Module
**NCT ID:** NCT03209479

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

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

#### Organization Study ID Info
**ID:** Glatiramer-5001
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
#### Secondary ID Infos
**Domain:** jRCT
**ID:** jRCT1080223004
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-31

**Type:** ACTUAL

#### Start Date
**Date:** 2015-11-24

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2017-07-06
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-04
**Study First Submit QC Date:** 2017-07-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Takeda

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.

**Detailed Description:** The drug being tested in this study is called Glatiramer acetate is being tested to treat people who have Multiple sclerosis. This study will look at the safety and efficacy of Glatiramer acetate in patients with multiple sclerosis in the routine clinical setting.

The study will enroll approximately 1000 patients.

• Glatiramer acetate subcutaneous injection syringe

This multi-center trial will be conducted in Japan.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1332

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily. Participants will receive interventions as part of routine medical care.

**Intervention Names:**

- Drug: Glatiramer acetate

**Label:** Glatiramer acetate

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Glatiramer acetate

**Description:** Copaxone subcutaneous injection syringe

**Name:** Glatiramer acetate

**Other Names:**

- Copaxone subcutaneous injection syringe

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Percentage of participants who had one or more adverse events

**Time Frame:** Up to 24 months

**Description:** The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.

**Measure:** Annual Relapse Rate (ARR)

**Time Frame:** Up to 24 months

#### Secondary Outcomes

**Measure:** Changes in the number of lesions from brain MRI findings

**Time Frame:** Up to 24 months

**Description:** 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.

**Measure:** Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS])

**Time Frame:** Up to 24 months

**Description:** 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.

**Measure:** Changes in functional evaluation scores (Functional Systems [FS])

**Time Frame:** Up to 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- All patients treated with Copaxone from the first day of market launch of the product

Exclusion Criteria:

-None

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tokyo

**Country:** Japan

**Facility:** Takeda selected site

#### Overall Officials

**Official 1:**

**Affiliation:** Takeda

**Name:** Study Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

**Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

### References Module

#### See Also Links

**Label:** To obtain more information on the study, click here/on this link

**URL:** https://clinicaltrials.takeda.com/study-detail/5f6b60234db2bf003ab49722

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Intervention Browse Module - Ancestors

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000018501

- Term: Antirheumatic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M297

- Name: Glatiramer Acetate

- Relevance: HIGH

- As Found: Replace

- ID: M147897

- Name: (T,G)-A-L

- Relevance: HIGH

- As Found: Replace

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068717

- Term: Glatiramer Acetate

- ID: C000021759

- Term: (T,G)-A-L

### Misc Info Module

- Version Holder: 2024-05-24
