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Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate (T8)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LTS 0.25mg
LTS 0.5mg
LTS 1.0mg
Placebo
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hydroxytriptolide, Rheumatoid Arthritis, Methotrexate, T8, LTS

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of bengbu medical college
  • Changzheng Hospital
  • Zhongshan Hospital Fudan University
  • Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.25mg

0.5mg

1.0mg

Placebo

Arm Description

LTS 0.25mg,qd MTX qw

LTS 0.5mg, qd MTX qw

LTS 1.0mg,qd MTX qw

Placebo qd MTX qw

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2014
Last Updated
June 2, 2017
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02202395
Brief Title
Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
December 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Hydroxytriptolide, Rheumatoid Arthritis, Methotrexate, T8, LTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25mg
Arm Type
Active Comparator
Arm Description
LTS 0.25mg,qd MTX qw
Arm Title
0.5mg
Arm Type
Active Comparator
Arm Description
LTS 0.5mg, qd MTX qw
Arm Title
1.0mg
Arm Type
Active Comparator
Arm Description
LTS 1.0mg,qd MTX qw
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo qd MTX qw
Intervention Type
Drug
Intervention Name(s)
LTS 0.25mg
Other Intervention Name(s)
Hydroxytriptolide
Intervention Description
use LTS 0.25mg/d
Intervention Type
Drug
Intervention Name(s)
LTS 0.5mg
Other Intervention Name(s)
Hydroxytriptolide
Intervention Description
use LTS 0.5mg/d
Intervention Type
Drug
Intervention Name(s)
LTS 1.0mg
Other Intervention Name(s)
Hydroxytriptolide
Intervention Description
use LTS 1.0mg/d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
use placebo once daily
Primary Outcome Measure Information:
Title
Change from baseline in ACR 20 at 12 weeks and at 24 weeks
Time Frame
12weeks, 24weeks
Secondary Outcome Measure Information:
Title
Change from baseline in DAS 28 at 12 weeks and at 24 weeks
Time Frame
12weeks, 24weeks
Title
The proportion of patients reached ACR50 at 12 weeks and 24 weeks
Time Frame
12weeks, 24weeks
Title
The proportion of patients reached ACR70 at 12weeks and 24weeks
Time Frame
12weeks,24weeks
Title
Change from baseline in swollen joint count at 12 weeks and 24 weeks
Time Frame
12weeks,24weeks
Title
Change from baseline in tender joint count at 12weeks and 24weeks
Time Frame
12weeks,24weeks
Title
Change from baseline in the duration of morning stiffness at 12 weeks and 24 weeks
Time Frame
12 weeks and 24 weeks
Title
Change from baseline in rest pain at 12 weeks and 24 weeks
Time Frame
12weeks,24weeks
Title
Change from baseline in PtGA patient global assessment at 12 weeks and 24 weeks
Time Frame
12 weeks and 24 weeks
Title
Change from baseline in PGA physician global assessment at 12 weeks and 24 weeks
Time Frame
12 weeks and 24 weeks
Title
Change from baseline in HAQ health assessment questionnaire at 12 weeks and 24 weeks
Time Frame
12 weeks, 24 weeks
Title
Change from baseline in CRP,ESR,RF,CCP at 12 weeks and 24 weeks
Time Frame
12 weeks, 24 weeks
Title
Change from baseline in IgA, IgG, IgM at 12 weeks and 24 weeks
Time Frame
12 weeks, 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunde Bao, MD
Organizational Affiliation
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of bengbu medical college
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

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

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