NCT02202395

Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS) in active rheumatoid arthritis patients with an inadequate response to methotrexate.

Detailed description

1. Investigate the efficacy of Hydroxytriptolide in active RA patients 2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system. 3. Population PK study.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	LTS 0.25mg	use LTS 0.25mg/d
DRUG	LTS 0.5mg	use LTS 0.5mg/d
DRUG	LTS 1.0mg	use LTS 1.0mg/d
DRUG	Placebo	use placebo once daily

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-04-30
• Completion: 2016-12-28
• First posted: 2014-07-29
• Last updated: 2017-06-05

Locations

5 sites across 1 country: China