NCT02202395CompletedPhase 1
A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Shanghai Pharmaceuticals Holding Co., Ltd5 sites in 1 country120 target enrollmentStarted: June 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- Change from baseline in ACR 20 at 12 weeks and at 24 weeks
Study Overview
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
- Investigate the efficacy of Hydroxytriptolide in active RA patients
- Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female reproductive system.
- Population PK study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
0.25mg
Active Comparator
LTS 0.25mg,qd MTX qw
Intervention: LTS 0.25mg (Drug)
0.5mg
Active Comparator
LTS 0.5mg, qd MTX qw
Intervention: LTS 0.5mg (Drug)
1.0mg
Active Comparator
LTS 1.0mg,qd MTX qw
Intervention: LTS 1.0mg (Drug)
Placebo
Placebo Comparator
Placebo qd MTX qw
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in ACR 20 at 12 weeks and at 24 weeks
Time Frame: 12weeks, 24weeks
Secondary Outcomes
- The proportion of patients reached ACR50 at 12 weeks and 24 weeks(12weeks, 24weeks)
- Change from baseline in DAS 28 at 12 weeks and at 24 weeks(12weeks, 24weeks)
- Change from baseline in swollen joint count at 12 weeks and 24 weeks(12weeks,24weeks)
- Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks(12 weeks and 24 weeks)
- Change from baseline in IgA, IgG, IgM at 12 weeks and 24 weeks(12 weeks, 24 weeks)
- Change from baseline in tender joint count at 12weeks and 24weeks(12weeks,24weeks)
- Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks(12 weeks and 24 weeks)
- The proportion of patients reached ACR70 at 12weeks and 24weeks(12weeks,24weeks)
- Change from baseline in rest pain at 12 weeks and 24 weeks(12weeks,24weeks)
- Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks(12 weeks, 24 weeks)
- Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks(12 weeks and 24 weeks)
- Change from baseline in CRP,ESR,RF,CCP at 12 weeks and 24 weeks(12 weeks, 24 weeks)
Investigators
Study Sites (5)
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