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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202395
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Pharmaceuticals Holding Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LTS 0.25mg Drug: LTS 0.5mg Drug: LTS 1.0mg Drug: Placebo Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0.25mg
LTS 0.25mg,qd MTX qw
Drug: LTS 0.25mg
use LTS 0.25mg/d
Other Name: Hydroxytriptolide

Active Comparator: 0.5mg
LTS 0.5mg, qd MTX qw
Drug: LTS 0.5mg
use LTS 0.5mg/d
Other Name: Hydroxytriptolide

Active Comparator: 1.0mg
LTS 1.0mg,qd MTX qw
Drug: LTS 1.0mg
use LTS 1.0mg/d
Other Name: Hydroxytriptolide

Placebo Comparator: Placebo
Placebo qd MTX qw
Drug: Placebo
use placebo once daily




Primary Outcome Measures :
  1. Change from baseline in ACR 20 at 12 weeks and at 24 weeks [ Time Frame: 12weeks, 24weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202395


Locations
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China, Anhui
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233004
China, Shanghai
Changzheng Hospital
Shanghai, Shanghai, China, 200003
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
Shanghai, Shanghai, China, 200127
Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Shanghai Pharmaceuticals Holding Co., Ltd
Investigators
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Principal Investigator: Chunde Bao, MD Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee
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Responsible Party: Shanghai Pharmaceuticals Holding Co., Ltd
ClinicalTrials.gov Identifier: NCT02202395    
Other Study ID Numbers: LTS-201-P1.0
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Keywords provided by Shanghai Pharmaceuticals Holding Co., Ltd:
Hydroxytriptolide
Rheumatoid Arthritis
Methotrexate
T8
LTS
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases