Clinical trial NCT04515706: Iguratimod in Systemic Sclerosis
Official title: Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis, Diffuse
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
timeFrame: Week 12, 24, 36, and 48
measure: Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
timeFrame: Week 12, 24, 36, and 48
measure: Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
timeFrame: Week 12, 24, and 48
measure: Scleroderma Clinical Trials Consortium Damage Index
timeFrame: Week 24, 48
measure: Change in Modified Rodnan Skin Score (mRSS)
timeFrame: Week 12, 24, 36, and 48
measure: Change in Skin Thickness
timeFrame: Week 24, 48
Other outcomes:
Locations:
Study officials:
References: