Rapamycin Plus Methylprednisolone Versus Methylprednisolone Alone in Active, Moderate-to-severe Graves' Orbitopathy.

Summary

This study is a randomized, controlled, multi-center clinical study, the purpose is to evaluate the efficacy and safety of rapamycin combined with methylprednisolone in the treatment of moderate to severe active GO.

GO patients with moderate to severe activity were selected as the research objects, and the screening period was 1 week. Eligible and well-informed subjects were randomly assigned 1:1 to the experimental group (rapamycin + methylprednisolone) or the control group (methylprednisolone group). The control group was given methylprednisolone pulse 500 mg/time once a week for 6 weeks + 250 mg/time once a week for 6 weeks, and the experimental group was given rapamycin 2 mg/day orally for 24 weeks on the basis of methylprednisolone pulse therapy. The follow-up period was from 25th to 36th week.

Before treatment, 1 week after treatment, 6 weeks, 12 weeks, 24 weeks, and 36 weeks, visits were conducted to evaluate the improvement and safety evaluation of patients' GO eye activity, severity, and quality of life. At the end of the 1st week and the 12th week, the blood concentration of rapamycin was measured.

Conditions

• Graves Ophthalmopathy

Interventions

DRUG

Rapamycin

Rapamycin plus Methylprednisolone

DRUG

Methylprednisolone

Methylprednisolone Alone

Sponsors & Collaborators

• Beijing Tongren Hospital

  collaborator OTHER

• Cheloo Hospital (Qingdao), Shandong University

  collaborator UNKNOWN

• Jiangsu Province Hospital with Integration of Chinese and Western Medicine

  collaborator UNKNOWN

• Nanjing First Hospital, Nanjing Medical University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• The Second Affiliated Hospital of Air Force Military Medical University

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Bingyin Shi · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2023-09-30

Completion

2023-09-30

FDA Drug

Yes

Countries

• China

Study Locations