Rheumatoid ArthritisPhase 3NCT04178850

Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

A Phase 3 study testing GB242 and Infliximab in people with Rheumatoid Arthritis, run by Genor Biopharma Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study compares the similarity of the proportion of subjects who achieved ACR20 at week 30 in the two groups. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: GB242 and Infliximab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 568 participants
Where: 1 siteChina
Study dates: 13 Oct 2017to Apr 2021
Phase: Phase 3
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Aged 18 to 75 years, males or females;
Subjects who have confirmed rheumatoid arthritis for at least 3 months according to 2010 American College of Rheumatology Classification Criteria (amendment);
The active stage is met at screening: the following 3 items should be met (based on 28 joints):
Swelling of 4 or more joints; tenderness of 6 or more joints; Tenderness of 6 or more joints; At least one of the following criteria is met: erythrocyte sedimentation rate >28mm/h or C-reactive protein >10mg/L (1mg/dl);
Subjects who have been treated with MTX treatment for at least 3 months before the before the use of invesetigational products and the dose remains stable (10~15mg/week) for at least 4 weeks;
The following DMARDs except MTX (including but not limited to chloroquine, hydroxychloroquine, gold preparation, penicillamine, sulfasalazine, azathioprine, cyclophosphamide, cyclosporin A, glucosinolate, auranofin etc.) are discontinued at least 4 weeks before the use of invesetigational products. Should any leflunomide is previously used, the subjects can be enrolled after 4 weeks after washout with cholestyramine (8g, three times per day) for 11 days. If leflunomide is discontinued 12 weeks ago, the patients can be enrolled without washout with cholestyramine.

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If glucocorticoids are being administered before the use of invesetigational products, the dose must be stable and remains ≤10mg/d (equivalent to the dose of prednisone) for at least 4 weeks; if no glucocorticoids is used, no oral administration is given at least 4 weeks ago or no local injection is given at least 12 weeks ago.
The Chinese traditional patent medicine or Chinese herbal medicine for RA treatment, physical therapy, inoculation with live (attenuated) viral/ bacterial vaccines, or intravenous injection of immunoglobulin (IgG) should be discontinued at least 4 weeks before the use of the use of invesetigational products;
If other biological preparations are used, or the subjects participated in clinical trials of other investigational products or marketed drugs before the use of invesetigational products, an interval of at least 3 months is required.
Female patients of child-bearing potential have negative pregnancy test at screening; both males and females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
Voluntarily participate in the clinical trial and sign the informed consent form;
Be able to understand and complete assessment forms;
Patients can well communicate with the investigators and complete the study as required by the study.

Who cannot join

The subjects received similar biological preparations (TNF inhibitors) for RA treatment within 3 months before randomization or were treated with TNF inhibitors 3 months ago, which are assessed as ineffective by the investigator.
Be allergic to any exicipent of the investigational products or any other murine or human-derived protein, hypersensitivity to immunoglobulin products, known to have medical history of allergic diseases or allergic constitution;
Body weight >100kg;
Subjects with rheumatoid arthritis with joint function classification of grade IV or subjects who combined to chair or bed (refer to appendix 9 for details of joint function classification);
Treatment with interferon within 4 weeks before the use of invesetigational products;
Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);

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Patients with known tuberculosis infection and patients with high risks for tuberculosis infection should be excluded. If patients with latent tuberculosis infection (LTBI) agree to receive preventive anti-tuberculosis therapies (appendix 5) during the study period, they can be enrolled. Or, they will be excluded.1) Known tuberculosis infection (any of the following criteria is met):
Active tuberculosis infection or presence of clinical signs and symptoms of suspected tuberculosis (pulmonary or extrapulmonary);B. Presence of active tuberculosis infection involved any organ system, or symptoms of other organ systems corresponding to tuberculosis infection;C. The radiology test or other imaging tests showing evidence of previous infection at screening or within the previous 3 months (obsolete tuberculosis evidence: scars of lung and/or pleural fiber; calcification of apex of lung or other sites; pulmonary hilus and /or mediastinal lymph node lesions; decreased volume of upper lobe of lung; pulmonary cavity).2) High risks for tuberculosis infection (any of the following criteria is met): A. Known to be in close contact with active tuberculosis patients within 3 months before screening; B. Subjects with low immunologic function and with evidence showing any latent tuberculosis infection (LTBI); C. Long stay with individuals infected with tuberculosis or long stay in medical service environment or institutions with high risks for tuberculosis transmission and infection;3) If patients with latent tuberculosis infection (LTBI) agree to receive preventive anti-tuberculosis therapies (appendix 5) during the study period, they can be enrolled. Or, they will be excluded.
LTBI is defined as no evidence showing signs or symptoms of tuberculosis infection or abnormal physical examination, and chest X-ray test (other imaging tests) results showing no evidence of tuberculosis infection, however, interferon gamma release assay (IGRA) is positive or the results of two IGRA tests are not clear;
Previous opportunistic infection (herpes zoster, cytomegalovirus, mycoplasma, pneumocystis carinii, histoplasma capsulatum, candida, aspergillus, mycobacterium other than mycobacterium tuberculosis etc.) within 6 months before screening;
Medical history of chronic infection (e.g., chronic hepatitis, chronic renal infection etc.), serious or life-threatening infection (e.g., hepatitis, pneumonitis and pyelonephritis etc.) or any current symptoms or signs indicating possible presence of infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
Patients who are in high risk for infection (e.g., leg ulcer, retention catheterization, persistent or recurrent chest infection and bedridden or wheelchair-bound for a long term);
Medical history of lymphoproliferative disorder (including lymphoma, or signs or symptoms reflecting lymphoproliferative disorders at any time); or splenomegaly;
Patients who previously or currently have malignant tumors within 5 years before screening (excluding adequately treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical in situ carcinoma);
Current or previous presence of congestive heart failure or medical history of congestive heart failure;
Current presence of interstitial lung disease or medical history of previous interstitial lung disease;
Current or previous presence of multiple sclerosis or other demyelinating diseases of the central nervous system or corresponding medical history of these diseases;
There is evidence showing that the patients have serious, progressive and uncontrolled cardiovascular, renal, hepatic, hemopoietic, gastrointestinal, endocrine, pulmonary, nervous system disorders; and other conditions who are considered unsuitable for participating in this study at the discretion of the investigator;
The following abnormal laboratory variables should be excluded: white blood cells (WBC) <3.0×109/L, neutrophil count (ANC)<1.5×109/L, platelet count (PLT) <100×109/L, hemoglobin (HGB) <85g/L, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alkaline phosphatase (ALP)> 2 times the upper limit of normal (ULN), serum creatinine (Cr) > 1.5 times ULN;
Current or previous presence of other systemic immune diseases (e.g., systemic lupus erythematosus etc.), or inflammatory joint disease other than rheumatoid arthritis (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy and Lyme disease etc.); Patients with rheumatoid arthritis complicated with secondary Sjogren syndrome which will not affect drug evaluation at the discretion of the investigator are allowed to be enrolled.
Subjects with medical history of prosthetic joint infection and the artificial joints are still in the body;
Subjects who received arthroplasty for more than 3 times;
Subjects who received organ transplantation within 6 months before screening;
Lactating women;
Subjects who have medical history of long-term alcohol abuse or drug abuse;
Subjects who have insufficient communication, understanding and cooperation, or subjects who have low education level, cannot understand and correctly complete corresponding forms, subjects who have history of noncompliance with doctor's instructions to receive administration, or subjects who have other conditions which may interfere with protocol compliance of subjects (e.g., subjects who have psychiatric disorders or usually travel, and lack of motivation to participate in the study);
Subjects who have other diseases (e.g., clinically significant symptoms or abnormal laboratory variables) which are considered unsuitable for participating in this clinical study at the discretion of the investigator; This study allows repeated screening at screening. The most recent test results prior to the first dose of all items are regarded as the baseline values.

Trial locations and contacts

1 site in 1 country.

Shawn Yu, Master contact

010-65260820

Shawn.Yu@genorbio.com

China1 site, 1 recruiting

Peking University People Hospital
Beijing, Beijing Municipality, 100044
Zhanguo Li, Ph.D, 010-88324173, zgli99@aliyun.com
Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multi-center Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.

This study compares the similarity of the proportion of subjects who achieved ACR20 at week 30 in the two groups.

Conditions: Rheumatoid Arthritis
Being tested: GB242, Infliximab
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

GB242Biological
Also called MTX, Folic acid
GB242: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses
InfliximabBiological
Also called MTX, Folic acid
Infliximab: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses

Study groups in NCT04178850
Study group	Role	What they receive
GB242	Experimental	3mg/kg Receives: Biological: GB242
Infliximab	Active comparator	3mg/kg Receives: Biological: Infliximab

What is being measured

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

Number of Participants with ACR20
Number of Participants with ACR20
Measured: Up to 30 weeks.

Secondary outcomes (12)

Number of Participants with ACR50
Number of Participants with ACR50
Measured: Up to 30 weeks.
Number of Participants with ACR70
Number of Participants with ACR70
Measured: Up to 30 weeks.
Number of Participants with DAS28
Number of Participants with DAS28
Measured: Up to 30 weeks.
Anti-Drug Antibody, ADA
Anti-Drug Antibody, ADA
Measured: Up to 30 weeks.
AUC τ
AUC τ
Measured: Up to 30 weeks.
C min,ss
C min,ss
Measured: Up to 30 weeks.
C max,ss
C max,ss
Measured: Up to 30 weeks.
C av,ss
C av,ss
Measured: Up to 30 weeks.
T 1/2
T 1/2
Measured: Up to 30 weeks.
CL ss /F
CL ss /F
Measured: Up to 30 weeks.
Adverse Effect, AE
Adverse Effect, AE
Measured: Up to 30 weeks.
Serious Adverse Efect, SAE
Serious Adverse Efect, SAE
Measured: Up to 30 weeks.

Timeline

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

13 Oct 2017Apr 2021

First posted26 Nov 2019
Study start13 Oct 2017
Primary completionDec 2020 (estimated)
Study completionApr 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 568 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04178850
Sponsor's protocol ID: GENOR GB242-002
Status last verified: Nov 2019
First submitted: 25 Nov 2019
Last updated: 27 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Shawn Yu, Master

010-65260820

Shawn.Yu@genorbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multi-center Phase Ⅲ Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.
ClinicalTrials.gov ID: NCT04178850
Acronym / sponsor ID: GENOR GB242-002
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 568 participants (estimated)
Lead sponsor: Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 Oct 2017 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Apr 2021 (estimated)
First posted: 26 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compares the similarity of the proportion of subjects who achieved ACR20 at week 30 in the two groups.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
GB242	Experimental	Biological: GB2423mg/kg
Infliximab	Active comparator	Biological: Infliximab3mg/kg

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Aged 18 to 75 years, males or females;
Subjects who have confirmed rheumatoid arthritis for at least 3 months according to 2010 American College of Rheumatology Classification Criteria (amendment);
The active stage is met at screening: the following 3 items should be met (based on 28 joints):
Swelling of 4 or more joints; tenderness of 6 or more joints; Tenderness of 6 or more joints; At least one of the following criteria is met: erythrocyte sedimentation rate >28mm/h or C-reactive protein >10mg/L (1mg/dl);
Subjects who have been treated with MTX treatment for at least 3 months before the before the use of invesetigational products and the dose remains stable (10~15mg/week) for at least 4 weeks;

Key exclusion criteria (27 listed)

The subjects received similar biological preparations (TNF inhibitors) for RA treatment within 3 months before randomization or were treated with TNF inhibitors 3 months ago, which are assessed as ineffective by the investigator.
Be allergic to any exicipent of the investigational products or any other murine or human-derived protein, hypersensitivity to immunoglobulin products, known to have medical history of allergic diseases or allergic constitution;
Body weight >100kg;
Subjects with rheumatoid arthritis with joint function classification of grade IV or subjects who combined to chair or bed (refer to appendix 9 for details of joint function classification);
Treatment with interferon within 4 weeks before the use of invesetigational products;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GB242Also: MTX, Folic acidGB242: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses	Biological	GB242
InfliximabAlso: MTX, Folic acidInfliximab: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses	Biological	Infliximab

Primary outcome

Number of Participants with ACR20
Time frame: Up to 30 weeks.
Number of Participants with ACR20

12 secondary outcomes

Number of Participants with ACR50
Time frame: Up to 30 weeks.
Number of Participants with ACR70
Time frame: Up to 30 weeks.
Number of Participants with DAS28
Time frame: Up to 30 weeks.
Anti-Drug Antibody, ADA
Time frame: Up to 30 weeks.
AUC τ
Time frame: Up to 30 weeks.
C min,ss
Time frame: Up to 30 weeks.
C max,ss
Time frame: Up to 30 weeks.
C av,ss
Time frame: Up to 30 weeks.
T 1/2
Time frame: Up to 30 weeks.
CL ss /F
Time frame: Up to 30 weeks.
Adverse Effect, AE
Time frame: Up to 30 weeks.
Serious Adverse Efect, SAE
Time frame: Up to 30 weeks.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shawn Yu, Master contact

010-65260820

Shawn.Yu@genorbio.com

Zhanguo Li, Ph.D principal investigator

Peking University People Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GB242 and Infliximab in people with Rheumatoid Arthritis, run by Genor Biopharma Co., Ltd. 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 13 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 27 Nov 2019. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Shawn Yu, Master (010-65260820, Shawn.Yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with ACR20 (time frame: Up to 30 weeks.). 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 NCT04178850.

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 27 Nov 2019.