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Immunosuppressant
Mycophenolate Mofetil for Systemic Sclerosis with Interstitial Lung Disease (SSc-mILD Trial)
Phase 2
Waitlist Available
Led By Sabrina Hoa, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening
SSc based on 2013 ACR-EULAR classification criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over one year
Awards & highlights
SSc-mILD Trial Summary
This trial will study the effects of a drug on people with mild lung involvement from systemic sclerosis. Participants will get either drug or placebo over 96 weeks at 3 centers.
Who is the study for?
This trial is for adults over 18 with systemic sclerosis and mild lung involvement, diagnosed within the last 7 years. Participants must have a stable lung function and be able to consent and follow the study plan. They can't join if they've had worsening lung fibrosis in the past year, are on certain other medications, pregnant or not using contraception, have blood disorders or liver issues, heart failure, active infections or cancer.Check my eligibility
What is being tested?
The study tests Mycophenolate Mofetil (MMF) against a placebo in people with systemic sclerosis who also have subclinical interstitial lung disease. It's designed to see if it's feasible to do a larger study on MMF's effectiveness for these patients over a period of 96 weeks.See study design
What are the potential side effects?
Mycophenolate Mofetil may cause side effects like stomach problems, blood cell count changes leading to increased infection risk or anemia, liver enzyme increases indicating potential liver damage, and possible interactions with other drugs.
SSc-mILD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function test shows I breathe well, meeting the required standard.
Select...
I have been diagnosed with systemic sclerosis according to the 2013 criteria.
SSc-mILD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to the study protocol as assessed by the number of protocol deviations
Adherence to treatment as assessed by Participant Dosing Diaries
Drug adherence rate as assessed by Pharmacy Accountability Logs
+10 moreSecondary outcome measures
Frequency of treatment-related adverse events
Other outcome measures
Annual rate of decline in percent (%) predicted DLCO over 96 weeks
Annual rate of decline in percent (%) predicted diffusion capacity for carbon monoxide (DLCO) over 48 weeks
Annual rate of decline in percent (%) predicted forced vital capacity (FVC) over 48 weeks
+37 moreSide effects data
From 2014 Phase 3 trial • 87 Patients • NCT0007547823%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
SSc-mILD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mycophenolate mofetilExperimental Treatment1 Intervention
2 to 4 capsules of mycophenolate mofetil twice daily.
Group II: PlaceboPlacebo Group1 Intervention
2 to 4 capsules of placebo twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,509 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,602 Total Patients Enrolled
McGill UniversityOTHER
394 Previous Clinical Trials
998,346 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function test shows I breathe well, meeting the required standard.I do not have any health conditions or situations that would make it unsafe for me to take MMF.I have been diagnosed with systemic sclerosis according to the 2013 criteria.My lung scan shows less than 20% fibrosis, confirmed by a specialist.I am taking medication that could affect my lung condition.My lung scarring has worsened in the last year without other causes.I was diagnosed with ILD within the last 7 years.I am 18 years or older.I can communicate in either French or English.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Mycophenolate mofetil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential side effects should be considered when taking Mycophenolate mofetil?
"Our team at Power assigns Mycophenolate mofetil a score of 2 on their safety scale, as this is classified as a Phase 2 trial. This means there is evidence to support its security but not its therapeutic efficacy."
Answered by AI
What is the status of enrollment for this clinical trial?
"As per clinicaltrials.gov, the advertised trial is not presently accruing participants. This investigation was first posted on May 1st 2023 and had its most recent update March 14th 2023. Despite this study no longer actively recruiting patients, there are 789 alternate trials seeking participants at present time."
Answered by AI
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