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

Rheumatoid Arthritis Clinical Trial

— T8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202395
• Other study ID #: LTS-201-P1.0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 23, 2014
• Last updated: June 2, 2017
• Start date: June 2014
• Est. completion date: December 28, 2016

Study information

• Verified date: June 2017
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 28, 2016
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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:

1. 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

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	Changhai Hospital	Shanghai	Shanghai
China	Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ACR 20 at 12 weeks and at 24 weeks		12weeks, 24weeks
Secondary	Change from baseline in DAS 28 at 12 weeks and at 24 weeks		12weeks, 24weeks
Secondary	The proportion of patients reached ACR50 at 12 weeks and 24 weeks		12weeks, 24weeks
Secondary	The proportion of patients reached ACR70 at 12weeks and 24weeks		12weeks,24weeks
Secondary	Change from baseline in swollen joint count at 12 weeks and 24 weeks		12weeks,24weeks
Secondary	Change from baseline in tender joint count at 12weeks and 24weeks		12weeks,24weeks
Secondary	Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks		12 weeks and 24 weeks
Secondary	Change from baseline in rest pain at 12 weeks and 24 weeks		12weeks,24weeks
Secondary	Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks		12 weeks and 24 weeks
Secondary	Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks		12 weeks and 24 weeks
Secondary	Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks		12 weeks, 24 weeks
Secondary	Change from baseline in CRP,ESR,RF,CCP at 12 weeks and 24 weeks		12 weeks, 24 weeks
Secondary	Change from baseline in IgA, IgG, IgM at 12 weeks and 24 weeks		12 weeks, 24 weeks