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

NCT02202395 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-06-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Chunde Bao, MD · Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-04-30
Completion
2016-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202395 on ClinicalTrials.gov