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Rheumatoid ArthritisPhase 1/2T8NCT02202395

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

A Phase 1/2 study testing LTS 0.25mg, LTS 0.5mg and LTS 1.0mg in people with Rheumatoid Arthritis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 years, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
LTS 0.25mg, LTS 0.5mg and LTS 1.0mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
5 sitesChina
Study dates
Jun 2014to 28 Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233004

  • Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

    Shanghai, Shanghai Municipality, 200127

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

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

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.

Read the 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.
Being tested
LTS 0.25mg, LTS 0.5mg, LTS 1.0mg, Placebo
Keywords
Hydroxytriptolide, Rheumatoid Arthritis, Methotrexate, T8, LTS
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTS 0.25mgDrug

    Also called Hydroxytriptolide

    use LTS 0.25mg/d

  • LTS 0.5mgDrug

    Also called Hydroxytriptolide

    use LTS 0.5mg/d

  • LTS 1.0mgDrug

    Also called Hydroxytriptolide

    use LTS 1.0mg/d

  • PlaceboDrug

    use placebo once daily

Study groups in NCT02202395
Study groupRoleWhat they receive
0.25mgActive comparatorLTS 0.25mg,qd MTX qw
Receives: Drug: LTS 0.25mg
0.5mgActive comparatorLTS 0.5mg, qd MTX qw
Receives: Drug: LTS 0.5mg
1.0mgActive comparatorLTS 1.0mg,qd MTX qw
Receives: Drug: LTS 1.0mg
PlaceboPlacebo comparatorPlacebo qd MTX qw
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12weeks, 24weeks

Secondary outcomes (12)

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

    Measured: 12weeks, 24weeks

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

    Measured: 12weeks, 24weeks

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

    Measured: 12weeks,24weeks

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

    Measured: 12weeks,24weeks

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

    Measured: 12weeks,24weeks

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

    Measured: 12 weeks and 24 weeks

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

    Measured: 12weeks,24weeks

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

    Measured: 12 weeks and 24 weeks

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

    Measured: 12 weeks and 24 weeks

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

    Measured: 12 weeks, 24 weeks

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

    Measured: 12 weeks, 24 weeks

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

    Measured: 12 weeks, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion30 Apr 2015
  4. Study completion28 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02202395
Sponsor's protocol ID
LTS-201-P1.0
Acronym
T8
Status last verified
Jun 2017
First submitted
23 Jul 2014
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LTS 0.25mg, LTS 0.5mg and LTS 1.0mg in people with Rheumatoid Arthritis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in ACR 20 at 12 weeks and at 24 weeks (time frame: 12weeks, 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02202395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.

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