- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515706
Iguratimod in Systemic Sclerosis
August 13, 2020 updated by: RenJi Hospital
Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
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
19 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iguratimod
Iguratimod 25 twice a day (bid) on Week 1-48.
|
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia.
Recent data reveal its independent anti-fibrosis effect.
|
Placebo Comparator: Placebo
Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.
|
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia.
Recent data reveal its independent anti-fibrosis effect.
Placebo of Iguratimod
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
Time Frame: 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.
|
Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
Time Frame: Week 12, 24, 36, and 48
|
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.
|
Week 12, 24, 36, and 48
|
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Time Frame: Week 12, 24, 36, and 48
|
Grade 2 or higher assessed 12 weeks apart.
Grade 2 AEs are determined as " moderate".
Grading was performed following CTCAE v 4.03 guidance.
|
Week 12, 24, 36, and 48
|
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
Time Frame: Week 12, 24, and 48
|
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.
|
Week 12, 24, and 48
|
Scleroderma Clinical Trials Consortium Damage Index
Time Frame: Week 24, 48
|
A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.
|
Week 24, 48
|
Change in Modified Rodnan Skin Score (mRSS)
Time Frame: Week 12, 24, 36, and 48
|
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
|
Week 12, 24, 36, and 48
|
Change in Skin Thickness
Time Frame: Week 24, 48
|
The skin thickness of fingers and palms would be measured by high frequency echo.
detector.
|
Week 24, 48
|
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 (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
January 31, 2023
Study Completion (Anticipated)
January 31, 2024
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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