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A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078386
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
RemeGen Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Biological: Placebo Biological: RC18 240 mg Biological: RC18 160 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome
Actual Study Start Date : November 21, 2019
Actual Primary Completion Date : June 23, 2021
Actual Study Completion Date : October 26, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: RC18 240mg Biological: RC18 240 mg
Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Experimental: RC18 160 mg Biological: RC18 160 mg
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Placebo Comparator: Placebo Biological: Placebo
Patients received the test group Placebo weekly administered subcutaneously for 24 times.


Outcome Measures
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Primary Outcome Measures :
  1. The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24. [ Time Frame: week 24 ]
    ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.


Secondary Outcome Measures :
  1. The amount of change of ESSDAI score compared to the baseline at week 12. [ Time Frame: week 12 ]
    ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular，peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.

  2. The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24 [ Time Frame: week 12，24 ]
    European League Against Rheumatism Sjögren's Syndrome Patient Reported Index.Dryness, pain, somatic and mental fatigue were identified as the main symptoms of patients with primary SS. It was suspected that a single 0-10 numerical scale for each domain was sufficient to assess these symptoms.The higher values represent a worse outcome.Subscales are combined by averaged.

  3. Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
    The measurement tool is Visual Analogue Scale/Score（VAS）.The doctor assesses participant's disease activity on a VAS of 0 - 100 mm on the questionnaire form.

  4. Overall patient assessment of disease activity compared to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
    The measurement tool is Visual Analogue Scale/Score（VAS）. The participant assesses his/her own disease activity on a VAS of 0 - 100 mm on the questionnaire form.

  5. Changes in short form(SF)-36 relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
    SF-36=36-item short form. As a concise health questionnaire, SF-36 summarized the quality of life of the subjects from eight aspects: physiological function, physical pain, general health condition, energy, social function, emotional function and mental health.The SF-361 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales. An additional item measures health transition.The higher values represent a better outcome.Subscales are combined by averaged.

  6. Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24 [ Time Frame: week 12,24 ]
    Multidimensional Fatigue Inventory.The MFI is a 20-item scale designed to evaluate fi ve dimensions of fatigue: general fatigue, physical fatigue, reduced motivation,reduced activity, and mental fatigue.The higher values represent a worse outcome,Subscales are combined by summed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily signed informed consent ;
  • Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
  • Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies
  • ESSDAI score ≥ 5.

Exclusion Criteria:

  • Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases;
  • Abnormal laboratory parameters need to be excluded, including but not limited to:
  • Immunosuppressive agents were used within 4 weeks prior to randomization.;
  • The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks;
  • Use of biological agents for targeted therapy in the first 6 months of randomization;
  • Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization;
  • The use of saliva-stimulating drugs within 7 days prior to randomization;
  • Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks;
  • Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization;
  • Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive;
  • Currently suffering from active hepatitis or severe liver lesions and history;
  • Malignant tumor patients ;
  • Combined with involvement of important organs or neuropathy;
  • Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the shorter).
  • Pregnant , lactating women and men or women who have birth plans during the research;
  • Investigator considers candidates not appropriating for the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078386


Locations
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China, Shandong
Remegen,Ltd.
Yantai, Shandong, China, 264006
Sponsors and Collaborators
RemeGen Co., Ltd.
Investigators
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Principal Investigator: Xiaofeng Zeng, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: RemeGen Co., Ltd.
ClinicalTrials.gov Identifier: NCT04078386    
Other Study ID Numbers: 18C012
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases