Back to resultsIguratimod in Systemic Sclerosis
Primary Purpose
Systemic Sclerosis, Diffuse
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iguratimod
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis, Diffuse
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
- Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).
- Agree to use effective contraception during the study period (women of childbearing age).
- Smokers agreed to quit smoking during the study.
- Ability to provide informed consent.
Exclusion Criteria:
- The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).
- Used rituximab within 3 months before screening.
- SSc with tumor.
- People with various lung infections, asthma or other lung diseases such as bronchiectasis.
- For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate <30ml/min; White blood cell count<3×109/L; Hemoglobin <80g/L; Platelet count<60×109/L; Heart function level III-IV; PaO2<50mmHg in resting state; FEV1/FVC<0.7.
- In the period of acute or chronic infection (not including finger ulcer combined infection).
- A history of peptic ulcer or bleeding within 6 months before screening.
- People with allergies or multiple drug allergies.
- People with mental illness or other reasons who cannot cooperate with treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Iguratimod
Placebo
Arm Description
Iguratimod 25 twice a day (bid) on Week 1-48.
Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.
Outcomes
Primary Outcome Measures
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Secondary Outcome Measures
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
Grade 3 or higher adverse events (AEs) assessed throughout the study ( 48 weeks). A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Grade 2 or higher assessed 12 weeks apart. Grade 2 AEs are determined as " moderate". Grading was performed following CTCAE v 4.03 guidance.
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
Scleroderma Clinical Trials Consortium Damage Index
A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.
Change in Modified Rodnan Skin Score (mRSS)
The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity
Change in Skin Thickness
The skin thickness of fingers and palms would be measured by high frequency echo. detector.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04515706
Brief Title
Iguratimod in Systemic Sclerosis
Official Title
Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Diffuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iguratimod
Arm Type
Experimental
Arm Description
Iguratimod 25 twice a day (bid) on Week 1-48.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Intervention Description
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of Iguratimod
Primary Outcome Measure Information:
Title
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
Description
Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
Description
Grade 3 or higher adverse events (AEs) assessed throughout the study ( 48 weeks). A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Time Frame
Week 12, 24, 36, and 48
Title
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Description
Grade 2 or higher assessed 12 weeks apart. Grade 2 AEs are determined as " moderate". Grading was performed following CTCAE v 4.03 guidance.
Time Frame
Week 12, 24, 36, and 48
Title
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
Description
CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
Time Frame
Week 12, 24, and 48
Title
Scleroderma Clinical Trials Consortium Damage Index
Description
A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.
Time Frame
Week 24, 48
Title
Change in Modified Rodnan Skin Score (mRSS)
Description
The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity
Time Frame
Week 12, 24, 36, and 48
Title
Change in Skin Thickness
Description
The skin thickness of fingers and palms would be measured by high frequency echo. detector.
Time Frame
Week 24, 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).
Agree to use effective contraception during the study period (women of childbearing age).
Smokers agreed to quit smoking during the study.
Ability to provide informed consent.
Exclusion Criteria:
The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).
Used rituximab within 3 months before screening.
SSc with tumor.
People with various lung infections, asthma or other lung diseases such as bronchiectasis.
For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate <30ml/min; White blood cell count<3×109/L; Hemoglobin <80g/L; Platelet count<60×109/L; Heart function level III-IV; PaO2<50mmHg in resting state; FEV1/FVC<0.7.
In the period of acute or chronic infection (not including finger ulcer combined infection).
A history of peptic ulcer or bleeding within 6 months before screening.
People with allergies or multiple drug allergies.
People with mental illness or other reasons who cannot cooperate with treatment.
12. IPD Sharing Statement
Plan to Share IPD
No
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Iguratimod in Systemic Sclerosis
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