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Iguratimod in Systemic Sclerosis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04515706
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis, Diffuse Drug: Iguratimod Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: Iguratimod
Iguratimod 25 twice a day (bid) on Week 1-48.
Drug: Iguratimod
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.
Drug: Iguratimod
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.

Drug: Placebo
Placebo of Iguratimod

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Change in Skin Thickness [ Time Frame: Week 24, 48 ]
    The skin thickness of fingers and palms would be measured by high frequency echo. detector.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: RenJi Hospital Identifier: NCT04515706    
Other Study ID Numbers: IGU
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases