Musculoskeletal Diseases

All Conditions

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Tripterygium

Treated with oral methotrexate and two placebos.

Treated with oral Tripterygium Wilfordii and two placebos.

Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.

Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.

Tripterygium Wilfordii

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.

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

Yisaipu

Xuan Zhang, MD

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.

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.

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

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

Incidence of adverse events and sever adverse events (SAE), including hospitalized or Treatment-emergent adverse events, during 24-week study.

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

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

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

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.

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

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.

Peking Union Medical College Hospital

Professor

Infections

Rare Diseases

Spondylitis

Spondylarthritis

Axial Spondyloarthritis

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Spondylarthropathies

Ankylosis

Spondylarthropathy

Analgesics

Gastrointestinal Agents

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week, Subcutaneous injection

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injectio, 25mg per week, Subcutaneous injection

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week

50mg Yisaipu

Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week

25mg etanercept

The injection method and frequency of placebo is the same as the other arms.

Placebo

Jieruo Gu, Professor

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary purpose is to assess the different situations in maintaining treatment programme in SpA patients with controlled inflammation by Yisaipu®. And the second purpose is to assess the eficacy and safety of Yisaipu® in axial SpAs. The trial will include 150 patients with stable NSAIDs therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the second stage the patients who achieve low disease activity (LDA, ASDAS\<2.1) at 24th week will be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu® group and placebo group. And the blind stage will last for 48 weeks. Patients who complete the 72-week therapy or achieve disease-flare criteria during the blind stage would finish the study.

This randomised controlled trial enrolled adult patients aged 18 years or older diagnosed with non-radiographic axial spondyloarthritis at 3 centres in China. Patients had to fulfil ASAS axial spondyloarthritis criteria but could not fulfil the modified New York radiologic criterion for ankylosing spondylitis,and had to have objective evidence of active inflammation or chronic structral change，such as bone erosion or fat metaplasia in the sacroiliac joints on MRI at screening. Active disease activity was defined as a disease activity score in ASDAS-CRP ≥2.1,or Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] ≥4 on a numerical rating scale of 0-10, and an inadequate response to more than one non-steroidal anti-inflammatory drugs (NSAIDs) for 4 weeks at least, intolerance to NSAIDs, or contraindication for NSAIDs. No change in NSAIDs dose was required from 2 weeks before screening to the end of the study. Dose stability or discontinuation was required for 4 weeks before baseline for concomitant DMARDs or corticosteroids (prednisone or equivalent at a dose of less than 10 mg/day). Chinese herbal medicine, physical therapy, or live (attenuated) vaccine, or intravenous immunoglobulin IgG, was required for discontinuation and wash period for at least 4 weeks. Patients were excluded if they had previously taken or were taking biologic treatment, any biologic Dmards such as IL-6 or CD-20 inhibitors. Patients with latent tuberculosis infection were included only when local guidelines were followed for prophylactic treatment and if treatment was initiated before Yisaipu.

All patients provided written informed consent, and the study protocol was approved by an institutional review board or independent ethics committee at each study site. The study was conducted in accordance with applicable regulations and the ethical principles of Good Clinical Practice as defined by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki.

A randomized envelope was used to enrol all patients at the baseline visit and to randomly assign qualifying patients in a 1:1:1 ratio to receive either blinded Yisaipu 50 mg subcutaneously every week or 25 mg subcutaneously every week or matching placebo at week 24. All study personnel, including the sponsor (with the exception of the Sanshengguojian drug supply management team), investigator, and study site personnel, and the patient remained blinded to treatment throughout the double-blinded period from week 24 through week 72 of the study. Investigational products were provided to maintain blinding.

In the initial open-label period, enrolled patients were given subcutaneous injections of 50 mg Yisaipu every week for 36 weeks. Participants were given the dose of NSAIDs they had been receiving at screening; a dose decrease or discontinuation was allowed when the patients were intolerance to NSAIDs, or contraindication for NSAIDs. Patients who achieved clinical remission, defined as achieving ASDAS inactive or moderate disease (ASDAS score \<2.1) at weeks 24, were randomly assigned to receive either blinded 50mg Yisaipu (continuation arm), 25mg Yisaipu(reduction arm) or matching placebo (withdrawal arm) for 48 weeks during the double-blind period, for a total of 72 weeks of treatment.

During the double-blind period, patients who experienced a flare (defined as an increase in BASDAI ≥2 points compare to the BASDAI score when randomization) were allocate to termination of this trial.

Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein

Treatment of Active Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection: a Randomized, Double-blind, Multicentral Clinical Trial to Investigate the Efficacy and Safety of Yisaipu®

in the groups given 50 mg Yisaipu, 25mg Yisaipu compared to placebo in the double-blind period

The unabbreviated scale title is VAS from 0 to 100mm. 100 mm mean the most severe pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA	NCT03589833	Arthritis, Rheu...	Tripterygium Wi... Methotrexate Yisaipu	18 Years - 65 Years	Peking Union Medical College Hospital
Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein	NCT02364479	Spondyloarthrit...	50mg Yisaipu 25mg etanercept Placebo	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for yisaipu

Every month we try and update this database with for yisaipu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yisaipu

Every month we try and update this database with for yisaipu cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yisaipu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.