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Arthritis, RheumatoidPhase 4YISTARNCT03589833

Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA

A Phase 4 study testing Tripterygium Wilfordii, Methotrexate and Yisaipu in people with Arthritis, Rheumatoid, run by Peking Union Medical College Hospital at 1 site 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

In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Tripterygium Wilfordii, Methotrexate and Yisaipu
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
504 participants
Where
1 siteChina
Study dates
14 May 2019to 27 Jul 2022
Phase
Phase 4
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years with informed consent
  • Diagnosis of rheumatoid arthritis (according to 2010 ACR/EULAR classification criteria)
  • Disease duration > 6 weeks
  • Swollen joint (SJC)≥4 and tender joint count(TJC)≥4
  • ESR >28 mm/hr or C-reactive protein > 1.5 ULN
  • Positive RF or anti-CCP antibody on screening
  • Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA
  • No evidence of active or latent or inadequately treated Mycobacterium tuberculosis infection

Who cannot join

  • Pregnant, lactating or further fertility requirements
  • Previously received any biologic agents.
  • Recently (<12 weeks) received methotrexate, leflunomide, salazosulfapyridine, azathioprine, cyclosporine, mycophenolate mofetil or Tripterygium Wilfordii.
  • Active or chronic infection, including HIV, HCV, HBV, tuberculosis.
  • History of any other rheumatic autoimmune disease
  • History of any lymphoproliferative disorder
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  • Malignancy or history of malignancy.
  • Abnormal laboratory tests, including: Hemoglobin <8.5 g/dL, White blood cell count <3.5 x 109/L, Platelet count <100 x 109/L, AST/ALT >1.5 ULN, and serum creatine > 1.5 mg/dL.
  • Severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease

Trial locations and contacts

1 site in 1 country.

China1 site

  • Deptment of Rheumatology, Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis

In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis.

Read the detailed description

This study evaluates the efficacy and safety of YISAIPU plus Tripterygium wilfordii (T2w) for the treatment of RA patients. YISAIPU is a recombinant human tumor necrosis factor receptor fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of Tripterygium wilfordii Hook F.

Objectives:

  1. To compare the efficacy of YISAIPU plus T2w versus MTX monotherapy for the treatment of signs and symptoms of RA.
  2. To evaluate the safety of YISAIPU plus T2w in patients with RA for 24 weeks.

Design:

This is a randomized, 24-week, double-blind, parallel group study, and 506 patients with active RA will be randomized in a 1:1:1:1 ratio to one of the following four parallel treatment arms:

  1. Methotrexate monotherapy
  2. T2w monotherapy
  3. YISAIPU plus methotrexate
  4. YISAIPU plus T2w

Escape:

On week 13, all participants with inadequate response, defined as a <30% improvement of swollen and tender joint counts from baseline, will switch to YISAIPU plus T2w treatment throughout the study.

Endpoints :

  1. ACR20, ACR50 and ACR70 response rates at 12 and 24 weeks.
  2. DAS 28 (CRP) and DAS 28 (ESR) at 12 and 24 weeks.
  3. EULAR response rates at 12 and 24 weeks.
  4. Health assessment questionnaire (HAQ) at 12 and 24 weeks.
  5. Patient assessment of arthritis pain at 12 and 24 weeks.
  6. Patient and physician global assessment of arthritis at 12 and 24 weeks.
Being tested
Tripterygium Wilfordii, Methotrexate, Yisaipu
Keywords
Rheumatoid Arthritis, Methotrexate, Tripterygium, TNF inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Tripterygium WilfordiiDrug

    Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.

  • MethotrexateDrug

    Oral methotrexate 7.5-15mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 15mg (max 0.3mg/Kg) per week in 4 weeks. Folic acid at the dose of 5 mg per week were applied to all participants.

  • YisaipuDrug

    Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.

Study groups in NCT03589833
Study groupRoleWhat they receive
MTXPlacebo comparatorTreated with oral methotrexate and two placebos.
Receives: Drug: Methotrexate
Tripterygium WilfordiiPlacebo comparatorTreated with oral Tripterygium Wilfordii and two placebos.
Receives: Drug: Tripterygium Wilfordii
Yisaipu + MTXActive comparatorTreated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
Receives: Drug: Methotrexate; Drug: Yisaipu
Yisaipu + Tripterygium WilfordiiExperimentalTreated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
Receives: Drug: Tripterygium Wilfordii; Drug: Yisaipu

What is being measured

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

  1. The American College of Rheumatology 50 (ACR50) response at 12 weeks

    The difference of ACR50 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

    Measured: week 12

Secondary outcomes (5)

  1. The American College of Rheumatology 20/70 (ACR20/ACR70) response at 12 weeks

    The difference of ACR20 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

    Measured: week 12

  2. The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks

    The difference of ACR20, ACR50 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 24.

    Measured: week 24

  3. The Disease Activity Score-28 (DAS28) response at 24 weeks

    The change in DAS28 score from baseline to week 24 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX).

    DAS28 ＝ 0.56*SQRT(TJC28) + 0.28*SQRT(SJC28) + 0.36*ln(CRP + 1) + 0.014*GH + 0.96

    • TJC28: The number of tender joints (0-28).
    • SJC28: The number of swollen joints (0-28).
    • CRP: The C-Reactive Protein level (in mg/l).
    • GH: The patient global health assessment (from 0=best to 100=worst).

    The 28 joint: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.

    Measured: week 24

  4. The European League Against Rheumatism (EULAR) response at 12 weeks

    The difference of proportions of patients meeting EULAR response between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

    Measured: week 12

  5. Health Assessment Questionnaire without Didability Index (HAQ-DI) at 12 weeks

    The change in HAQ-DI score from baseline to week 12 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX).

    HAQ-DI is an index measuring the quality of life related to health, which includes 20 questions in terms of three categories:

    • from 0 to 1: mild difficulties to moderate disability,
    • from 1 to 2: disability moderate to severe,
    • from 2 to 3: severe to very severe disability.

    The mean score is recorded as the result.

    Measured: week 12

Timeline

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

  1. First posted18 Jul 2018
  2. Study start14 May 2019
  3. Primary completion20 Mar 2022
  4. Study completion27 Jul 2022

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03589833
Sponsor's protocol ID
YISTAR
Acronym
YISTAR
Status last verified
Oct 2022
First submitted
5 Jul 2018
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang X, Yang H, Zuo X, Wu L, Peng J, Li Z, Li H, Ji W, Zhang L, Li X, Dai L, Lu L, Yang N, Wei W, Shuai Z, Jiang Y, Liu Y, Lipsky PE, Chen H; YISTAR study group. Efficacy and safety of tripterygium wilfordii Hook F plus TNF inhibitor for active rheumatoid arthritis: A multicentre, randomized, double-blind, triple-dummy controlled trial. Clin Immunol. 2023 Oct;255:109749. doi: 10.1016/j.clim.2023.109749. Epub 2023 Aug 30.

    PubMed 37657525

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tripterygium Wilfordii, Methotrexate and Yisaipu in people with Arthritis, Rheumatoid, run by Peking Union Medical College Hospital at 1 site 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 8 inclusion and 9 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

The American College of Rheumatology 50 (ACR50) response at 12 weeks (time frame: week 12). 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 NCT03589833, which also lists 1 linked publication.

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 25 Oct 2022.

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