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

NCT02202395 | Completed Phase 1 DMC

• 1 other identifier: LTS-201-P1.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Rheumatoid Arthritis

Keywords

Hydroxytriptolide; Rheumatoid Arthritis; Methotrexate; T8; LTS

Outcome Measures

Primary Outcomes (1)

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

  12weeks, 24weeks

Secondary Outcomes (12)

• Change from baseline in DAS 28 at 12 weeks and at 24 weeks

  12weeks, 24weeks

• The proportion of patients reached ACR50 at 12 weeks and 24 weeks

  12weeks, 24weeks

• The proportion of patients reached ACR70 at 12weeks and 24weeks

  12weeks,24weeks

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

  12weeks,24weeks

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

  12weeks,24weeks

Study Arms (4)

0.25mg

ACTIVE COMPARATOR

LTS 0.25mg,qd MTX qw

Drug: LTS 0.25mg

0.5mg

ACTIVE COMPARATOR

LTS 0.5mg, qd MTX qw

Drug: LTS 0.5mg

1.0mg

ACTIVE COMPARATOR

LTS 1.0mg,qd MTX qw

Drug: LTS 1.0mg

Placebo

PLACEBO COMPARATOR

Placebo qd MTX qw

Drug: Placebo

Interventions

LTS 0.25mg DRUG

use LTS 0.25mg/d

Also known as: Hydroxytriptolide

0.25mg

LTS 0.5mg DRUG

use LTS 0.5mg/d

Also known as: Hydroxytriptolide

0.5mg

LTS 1.0mg DRUG

use LTS 1.0mg/d

Also known as: Hydroxytriptolide

1.0mg

Placebo DRUG

use placebo once daily

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, female, postmenopausal, parous, nulliparous with no fertility requirements
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (5)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233004, China

Location

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

Shanghai, Shanghai Municipality, 200127, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Chunde Bao, MD

  Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 29, 2014
• Study Start: June 1, 2014
• Primary Completion: April 30, 2015
• Study Completion: December 28, 2016
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

CN (5)