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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.

Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE November 21, 2019
Actual Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
Official Title  ICMJE 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
Brief Summary The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Sjögren's Syndrome
Intervention  ICMJE
  • Biological: Placebo
    Patients received the test group Placebo weekly administered subcutaneously for 24 times.
  • Biological: RC18 240 mg
    Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
  • Biological: RC18 160 mg
    Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Study Arms  ICMJE
  • Experimental: RC18 240mg
    Intervention: Biological: RC18 240 mg
  • Experimental: RC18 160 mg
    Intervention: Biological: RC18 160 mg
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2021)
42
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2019)
30
Actual Study Completion Date  ICMJE October 26, 2021
Actual Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04078386
Other Study ID Numbers  ICMJE 18C012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party RemeGen Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RemeGen Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaofeng Zeng, M.D. Peking Union Medical College Hospital
PRS Account RemeGen Co., Ltd.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP