- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078386
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
January 7, 2022 updated by: RemeGen Co., Ltd.
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
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Yantai, Shandong, China, 264006
- Remegen,ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Patients received the test group Placebo weekly administered subcutaneously for 24 times.
|
EXPERIMENTAL: RC18 240mg
|
Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
|
EXPERIMENTAL: RC18 160 mg
|
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
week 12
|
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.
|
week 12,24
|
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.
|
week 12,24
|
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.
|
week 12,24
|
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.
|
week 12,24
|
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.
|
week 12,24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 21, 2019
Primary Completion (ACTUAL)
June 23, 2021
Study Completion (ACTUAL)
October 26, 2021
Study Registration Dates
First Submitted
July 18, 2019
First Submitted That Met QC Criteria
September 1, 2019
First Posted (ACTUAL)
September 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
Other Study ID Numbers
- 18C012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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