Skip to main content
OpenTrials
Completed

NCT Number: NCT02202395

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LTS 0.25mg

Drug

use LTS 0.25mg/d

Other names: Hydroxytriptolide

LTS 0.5mg

Drug

use LTS 0.5mg/d

Other names: Hydroxytriptolide

LTS 1.0mg

Drug

use LTS 1.0mg/d

Other names: Hydroxytriptolide

Placebo

Drug

use placebo once daily

Primary outcomes

  1. Change from baseline in ACR 20 at 12 weeks and at 24 weeks

    Time frame: 12weeks, 24weeks

Secondary outcomes

  1. Change from baseline in DAS 28 at 12 weeks and at 24 weeks

    Time frame: 12weeks, 24weeks

  2. The proportion of patients reached ACR50 at 12 weeks and 24 weeks

    Time frame: 12weeks, 24weeks

  3. The proportion of patients reached ACR70 at 12weeks and 24weeks

    Time frame: 12weeks,24weeks

  4. Change from baseline in swollen joint count at 12 weeks and 24 weeks

    Time frame: 12weeks,24weeks

  5. Change from baseline in tender joint count at 12weeks and 24weeks

    Time frame: 12weeks,24weeks

  6. Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks

    Time frame: 12 weeks and 24 weeks

  7. Change from baseline in rest pain at 12 weeks and 24 weeks

    Time frame: 12weeks,24weeks

  8. Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks

    Time frame: 12 weeks and 24 weeks

  9. Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks

    Time frame: 12 weeks and 24 weeks

  10. Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks

    Time frame: 12 weeks, 24 weeks

  11. Change from baseline in CRP,ESR,RF,CCP at 12 weeks and 24 weeks

    Time frame: 12 weeks, 24 weeks

  12. Change from baseline in IgA, IgG, IgM at 12 weeks and 24 weeks

    Time frame: 12 weeks, 24 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

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

Acronym: T8

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 29, 2014
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.