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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04178850
Date of registration: 25/11/2019
Prospective Registration: No
Primary sponsor: Genor Biopharma Co., Ltd.
Public title: Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection
Scientific title: A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.
Date of first enrolment: October 13, 2017
Target sample size: 568
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04178850
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 3
Countries of recruitment
China
Contacts
Name:     Zhanguo Li, Ph.D
Address: 
Telephone: 010-88324173
Email: zgli99@aliyun.com
Affiliation: 
Name:     Shawn Yu, Master
Address: 
Telephone: 010-65260820
Email: Shawn.Yu@genorbio.com
Affiliation: 
Name:     Zhanguo Li, Ph.D
Address: 
Telephone:
Email:
Affiliation:  Peking University People Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Aged 18 to 75 years, males or females;

2. Subjects who have confirmed rheumatoid arthritis for at least 3 months according to
2010 American College of Rheumatology Classification Criteria (amendment);

3. 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);

4. 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;

5. 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.

6. 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.

7. 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;

8. 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.

9. 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.

10. Voluntarily participate in the clinical trial and sign the informed consent form;

11. Be able to understand and complete assessment forms;

12. Patients can well communicate with the investigators and complete the study as
required by the study.

Exclusion Criteria:

1. 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.

2. 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;

3. Body weight >100kg;

4. 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);

5. Treatment with interferon within 4 weeks before the use of invesetigational products;

6. 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);

7. 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):

A. 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;

8. Previous opportunistic infection (herpes zoster, cytomegalovirus, mycoplasma,
pneumocystis carinii, histoplasma capsulatum, candida, aspergillus, mycobacterium
other than mycobacterium tuberculosis etc.) within 6 months before screening;

9. 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.)

10. Patients who are in high risk for infection (e.g., leg ulcer, retention
catheterization, persistent or recurrent che



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: GB242
Biological: Infliximab
Primary Outcome(s)
Number of Participants with ACR20 [Time Frame: Up to 30 weeks.]
Secondary Outcome(s)
Adverse Effect, AE [Time Frame: Up to 30 weeks.]
Anti-Drug Antibody, ADA [Time Frame: Up to 30 weeks.]
AUC t [Time Frame: Up to 30 weeks.]
C av,ss [Time Frame: Up to 30 weeks.]
C max,ss [Time Frame: Up to 30 weeks.]
C min,ss [Time Frame: Up to 30 weeks.]
CL ss /F [Time Frame: Up to 30 weeks.]
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.]
Serious Adverse Efect, SAE [Time Frame: Up to 30 weeks.]
T 1/2 [Time Frame: Up to 30 weeks.]
Secondary ID(s)
GENOR GB242-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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