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Adult Spinal Muscular Atrophy (SMA) China Registry

Active, not recruiting
Conditions
Muscular Atrophy, Spinal
Registration Number
NCT05618379
Lead Sponsor
Biogen
Brief Summary

The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) among adult Chinese participants with SMA linked to chromosome 5q (5q-SMA).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria

-Genetically confirmed 5q-SMA.

Key

Exclusion Criteria

-Other types of SMA (non 5q-SMA).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants Characterized by Utilization of Disease Modifying Therapies (DMTs) of 5q-SMA Observed Among Adult Chinese ParticipantsUp to 60 Months

The DMT utilization characteristics will include the categories of the evolution of the DMT treated patient's condition over the time of data collection from the registry, to describe the utilization of DMTs of adult SMA patients in a real-life situation.

Number of Participants Characterized by Natural History of 5q-SMA Observed Among Adult Chinese ParticipantsUp to 60 Months

The natural history characteristics will include the categories of the evolution of the patient's condition over the time of data collection from the registry, to describe the natural history of the disease in a real-life situation.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (12)

The First People's Hospital of Yunnan Province

🇨🇳

Kunming, Yunnan, China

Huashan Hospital, Fudan University

🇨🇳

Shanghai, Shanghai, China

Peking Union Medical College Hospital

🇨🇳

Beijing, Beijing, China

The First Affiliated Hospital, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

The First Affiliated Hospital of Fujian Medical University

🇨🇳

Fuzhou, Fujian, China

The First Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

The Second Hospital of Hebei Medical University

🇨🇳

Shijiazhuang, Hebei, China

Peking University Shenzhen Hospital

🇨🇳

Shenzhen, Guangdong, China

Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

🇨🇳

Nanchang, Jiangxi, China

Qilu Hospital of Shandong University

🇨🇳

Jinan, Shandong, China

West China Hospital, Sichuan University

🇨🇳

Chengdu, Sichuan, China

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