Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
NCT ID: NCT02202395
Last Updated: 2017-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2014-06-30
2016-12-28
Brief Summary
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Detailed Description
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2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system.
3. Population PK study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.25mg
LTS 0.25mg,qd MTX qw
LTS 0.25mg
use LTS 0.25mg/d
0.5mg
LTS 0.5mg, qd MTX qw
LTS 0.5mg
use LTS 0.5mg/d
1.0mg
LTS 1.0mg,qd MTX qw
LTS 1.0mg
use LTS 1.0mg/d
Placebo
Placebo qd MTX qw
Placebo
use placebo once daily
Interventions
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LTS 0.25mg
use LTS 0.25mg/d
LTS 0.5mg
use LTS 0.5mg/d
LTS 1.0mg
use LTS 1.0mg/d
Placebo
use placebo once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 1987 ACR Diagnostic criteria or 2009 ACR/EULAR Diagnostic criteria. X ray of Evaluable Joint in phase I/II/III, Joint Function in Phase I/II/III
* Active RA
* Continuously taking MTX for at least three months, ≥7.5mg/week. Before first study dose, keep in stable MTX dose for at least 4 weeks
* Keep in stable NSAIDs dose or low-dose glucocorticoids for at least 4 weeks before first study dose
* Using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose
* Using DMARD should have appropriate withdrawal period:
* Withdrawal for 4 weeks: Sulfasalazine, Azathioprine, Chloroquine, \*Hydroxychloroquine, Auranofin, Penicillamine, Traditional Chinese medicine preparation(TGP, Sinomenine)
* Withdrawal for 8 weeks: Leflunomide
* Withdrawal for 8 weeks: Intramuscular, intravenous, intra-articular injection glucocorticoids
* Women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical
* Voluntary informed consent
* Willing to follow the required regimen and schedule, follow-up examination
Exclusion Criteria
2. With severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
3. The evaluable joint underwent the surgical treatment within 2 months
4. Currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases
5. Currently or have malignancy, lymphoproliferative disease history
6. Continuously use Tripterygium preparations for more than three months and have no effect
7. History of using TNF-a inhibitors of biological agents.(Adalimumab, infliximab, etanercept)
8. Severe or persistent infection within 3 months
9. X-ray shows active pulmonary infection
10. HBV, HCV, HIV, AIDS
11. WBC\<4.0×10\^9/L, PLT\<100×10\^9/L, Hb\<85g/L
12. AST\>2×ULN, ALT\>2×ULN
13. Cr\>135umol/L
14. Used oral contraceptive druds within 3 months
15. Pregnancy test was positive or lactating patients or patients with birth preparation
16. Have to use the prohibited drugs
17. With clinical symptoms of a serious history of drug abuse or alcohol abuse
18. History of any durg clinical trials within 3 months
19. Allergy to tripterygium
20. Other reasons depends by the investigator
35 Years
65 Years
FEMALE
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chunde Bao, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Changzheng Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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LTS-201-P1.0
Identifier Type: -
Identifier Source: org_study_id
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