Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT04515706
Status:
UNKNOWN
Last Update Posted:
2020-08-17
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iguratimod in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C519076', 'term': 'iguratimod'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study', 'timeFrame': 'Week 12, 24, 36, and 48', '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.'}, {'measure': 'Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study', 'timeFrame': 'Week 12, 24, 36, and 48', '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.'}, {'measure': 'Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis', 'timeFrame': 'Week 12, 24, and 48', '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.'}, {'measure': 'Scleroderma Clinical Trials Consortium Damage Index', 'timeFrame': 'Week 24, 48', 'description': 'A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.'}, {'measure': 'Change in Modified Rodnan Skin Score (mRSS)', 'timeFrame': 'Week 12, 24, 36, and 48', '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'}, {'measure': 'Change in Skin Thickness', 'timeFrame': 'Week 24, 48', 'description': 'The skin thickness of fingers and palms would be measured by high frequency echo. detector.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis, Diffuse']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.\n* 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).\n* Agree to use effective contraception during the study period (women of childbearing age).\n* Smokers agreed to quit smoking during the study.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* 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).\n* Used rituximab within 3 months before screening.\n* SSc with tumor.\n* People with various lung infections, asthma or other lung diseases such as bronchiectasis.\n* 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.\n* In the period of acute or chronic infection (not including finger ulcer combined infection).\n* A history of peptic ulcer or bleeding within 6 months before screening.\n* People with allergies or multiple drug allergies.\n* People with mental illness or other reasons who cannot cooperate with treatment.'}, 'identificationModule': {'nctId': 'NCT04515706', 'briefTitle': 'Iguratimod in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'IGU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iguratimod', 'description': 'Iguratimod 25 twice a day (bid) on Week 1-48.', 'interventionNames': ['Drug: Iguratimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.', 'interventionNames': ['Drug: Iguratimod', 'Drug: Placebo']}], 'interventions': [{'name': 'Iguratimod', 'type': 'DRUG', 'description': 'Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.', 'armGroupLabels': ['Iguratimod', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of Iguratimod', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}