Systemic Sclerosis, DiffuseNCT04515706
Iguratimod in Systemic Sclerosis
A study testing Iguratimod in people with Systemic Sclerosis, Diffuse, run by RenJi Hospital.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Systemic Sclerosis, Diffuse
- What is being tested?
- Iguratimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
- Conditions
- Systemic Sclerosis, Diffuse
- Being tested
- Iguratimod, Placebo
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.
PlaceboDrug
Placebo of Iguratimod
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Experimental | Iguratimod 25 twice a day (bid) on Week 1-48. Receives: Drug: Iguratimod |
| Placebo | Placebo comparator | Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48. Receives: Drug: Iguratimod; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before 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.
Measured: Week 24
Secondary outcomes (6)
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
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.
Measured: Week 12, 24, 36, and 48
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Grade 2 or higher assessed 12 weeks apart. Grade 2 AEs are determined as " moderate". Grading was performed following CTCAE v 4.03 guidance.
Measured: Week 12, 24, 36, and 48
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
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.
Measured: Week 12, 24, and 48
Scleroderma Clinical Trials Consortium Damage Index
A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.
Measured: Week 24, 48
Change in Modified Rodnan Skin Score (mRSS)
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
Measured: Week 12, 24, 36, and 48
Change in Skin Thickness
The skin thickness of fingers and palms would be measured by high frequency echo. detector.
Measured: Week 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515706
- Sponsor's protocol ID
- IGU
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04515706
- Acronym / sponsor ID
- IGU
- Conditions
- Systemic Sclerosis, Diffuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iguratimod | Experimental | Drug: IguratimodIguratimod 25 twice a day (bid) on Week 1-48. |
| Placebo | Placebo comparator | Drug: Iguratimod, Drug: PlaceboPlacebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IguratimodIguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect. | Drug | Iguratimod, Placebo |
| PlaceboPlacebo of Iguratimod | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
Time frame: Week 12, 24, 36, and 48
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Time frame: Week 12, 24, 36, and 48
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
Time frame: Week 12, 24, and 48
Scleroderma Clinical Trials Consortium Damage Index
Time frame: Week 24, 48
Change in Modified Rodnan Skin Score (mRSS)
Time frame: Week 12, 24, 36, and 48
Change in Skin Thickness
Time frame: Week 24, 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Iguratimod in people with Systemic Sclerosis, Diffuse, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.