Status:
COMPLETED
Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Rheumatoid Arthritis
Eligibility:
FEMALE
35-65 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements
- 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
- Currently suffering or have suffered from other inflammatory joint diseases, such as mixed connective tissue disease, scleroderma, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, Reiter's syndrome, bone arthritis, rheumatoid arthritis, gouty arthritis, diagnosis of arthritis before 16yrs
- With severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
- The evaluable joint underwent the surgical treatment within 2 months
- Currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases
- Currently or have malignancy, lymphoproliferative disease history
- Continuously use Tripterygium preparations for more than three months and have no effect
- History of using TNF-a inhibitors of biological agents.(Adalimumab, infliximab, etanercept)
- Severe or persistent infection within 3 months
- X-ray shows active pulmonary infection
- HBV, HCV, HIV, AIDS
- WBC\<4.0×10\^9/L, PLT\<100×10\^9/L, Hb\<85g/L
- AST\>2×ULN, ALT\>2×ULN
- Cr\>135umol/L
- Used oral contraceptive druds within 3 months
- Pregnancy test was positive or lactating patients or patients with birth preparation
- Have to use the prohibited drugs
- With clinical symptoms of a serious history of drug abuse or alcohol abuse
- History of any durg clinical trials within 3 months
- Allergy to tripterygium
- Other reasons depends by the investigator
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02202395
Start Date
June 1 2014
End Date
December 28 2016
Last Update
June 5 2017
Active Locations (5)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233004
2
Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
3
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
4
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
Shanghai, Shanghai Municipality, China, 200127