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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02202395
• Date of registration: 23/07/2014
• Prospective Registration: No
• Primary sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
• Public title: Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate T8
• Scientific title: A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
• Date of first enrolment: June 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02202395
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

China

Contacts

• Name: Chunde Bao, MD
• Affiliation: Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: LTS 1.0mg

Drug: LTS 0.5mg

Drug: LTS 0.25mg

Drug: Placebo

Primary Outcome(s)

Change from baseline in ACR 20 at 12 weeks and at 24 weeks [Time Frame: 12weeks, 24weeks]

Secondary Outcome(s)

Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks [Time Frame: 12 weeks and 24 weeks]

Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks [Time Frame: 12 weeks and 24 weeks]

Change from baseline in rest pain at 12 weeks and 24 weeks [Time Frame: 12weeks,24weeks]

Change from baseline in DAS 28 at 12 weeks and at 24 weeks [Time Frame: 12weeks, 24weeks]

Change from baseline in swollen joint count at 12 weeks and 24 weeks [Time Frame: 12weeks,24weeks]

The proportion of patients reached ACR50 at 12 weeks and 24 weeks [Time Frame: 12weeks, 24weeks]

The proportion of patients reached ACR70 at 12weeks and 24weeks [Time Frame: 12weeks,24weeks]

Change from baseline in IgA, IgG, IgM at 12 weeks and 24 weeks [Time Frame: 12 weeks, 24 weeks]

Change from baseline in CRP,ESR,RF,CCP at 12 weeks and 24 weeks [Time Frame: 12 weeks, 24 weeks]

Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks [Time Frame: 12 weeks, 24 weeks]

Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks [Time Frame: 12 weeks and 24 weeks]

Change from baseline in tender joint count at 12weeks and 24weeks [Time Frame: 12weeks,24weeks]

Secondary ID(s)

LTS-201-P1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors