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Iguratimod in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT04515706
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
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.



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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
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.
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Responsible Party: RenJi Hospital
ClinicalTrials.gov 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
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases