Trial · NCT04515706
Iguratimod in Systemic Sclerosis
NCT04515706, Not applicable, Unknown, RenJi Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iguratimod in Systemic Sclerosis. Trials, record NCT04515706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04515706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iguratimod in Systemic Sclerosis
- NCT number
- NCT04515706
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 20 participants, estimated
- Lead sponsor
- RenJi Hospital
- Conditions
- Systemic Sclerosis, Diffuse
- Interventions
- Iguratimod, Placebo
- First posted
- 2020-08-17
- Last updated
- 2020-08-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24 | 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 | Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study | 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. |
| Secondary | Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study | 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. |
| Secondary | Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis | 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. |
| Secondary | Scleroderma Clinical Trials Consortium Damage Index | Week 24, 48 | A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc. |
| Secondary | Change in Modified Rodnan Skin Score (mRSS) | 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 |
| Secondary | Change in Skin Thickness | Week 24, 48 | The skin thickness of fingers and palms would be measured by high frequency echo. detector. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04515706
GET https://conductscience.org/api/trials/v1/NCT04515706/registered