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Anti-metabolites
Prednisone/Prednisolone Dosing for Cardiac Sarcoidosis (CHASM-CS-RCT Trial)
Phase 3
Recruiting
Led By David H Birnie, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
FDG-PET uptake suggestive of active CS within two months of enrollment (confirmed by PET core lab read)
Cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease (defined as Mobitz II AV block or third degree AV block), significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias), non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction (LVEF < 50%), right ventricular dysfunction (RVEF < 40%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
CHASM-CS-RCT Trial Summary
This trial is comparing the effectiveness of two different doses of Prednisone (or Prednisolone), one standard and one low, in patients with cardiac sarcoidosis who have not yet been treated. The Investigators hypothesize that the low dose will be just as effective as the standard dose, but with better quality of life and less toxicity.
Who is the study for?
This trial is for patients with acute active cardiac sarcoidosis, confirmed by PET scans and biopsies, who haven't been treated yet. They should have specific heart issues like arrhythmias or reduced heart function but can't be pregnant, breastfeeding, or on Methotrexate/Prednisone for other conditions.Check my eligibility
What is being tested?
The study compares a low dose combo of Prednisone (or Prednisolone) with Methotrexate to a standard dose of Prednisone alone in treating cardiac sarcoidosis. The goal is to see if the combo works as well while improving life quality and causing less toxicity.See study design
What are the potential side effects?
Possible side effects include increased risk of infections, mood swings, high blood sugar levels from Prednisone; and liver damage, lung issues, or mouth sores from Methotrexate.
CHASM-CS-RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent PET scan shows active cancer.
Select...
I have heart issues due to sarcoidosis, like irregular heartbeats or weak heart muscles.
Select...
My CT scan shows signs of sarcoidosis or swollen lymph nodes in my chest.
CHASM-CS-RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Summed perfusion rest score (SPRS) on FDG-PET scan
Secondary outcome measures
BMI
Blood pressure
CMR Endpoints
+16 moreSide effects data
From 2015 Phase 3 trial • 139 Patients • NCT0200198711%
Rheumatoid arthritis
11%
Rhinitis
9%
Asthenia
9%
Bronchitis
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
8%
Arthralgia
8%
Headache
7%
Neutropenia
6%
Diarrhoea
5%
Hepatocellular injury
5%
Back pain
5%
Transaminases increased
5%
Insomnia
5%
Abdominal pain
4%
Urinary tract infection
3%
Ear infection
3%
Injection site erythema
3%
Pruritus
2%
Nausea
2%
Hypertension
1%
Gastric volvulus
1%
Angioedema
1%
Gastric ulcer
1%
Intestinal ischaemia
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Cataract
1%
Cervical dysplasia
1%
Disseminated tuberculosis
1%
Septic shock
1%
Meningitis tuberculous
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ COMBO - All Participants
TCZ - All Participants
TCZ MONO - All Participants
CHASM-CS-RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MethotrexateExperimental Treatment2 Interventions
[Dose everywhere except Japan] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid 2 mg po daily for 6 months.
[Dose in Japan] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.
Group II: Prednisone (or Prednisolone)Active Control1 Intervention
[Dose everywhere except Japan] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg)
[Dose in Japan] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Methotrexate
FDA approved
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,242 Total Patients Enrolled
2 Trials studying Cardiac Sarcoidosis
1,500 Patients Enrolled for Cardiac Sarcoidosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,504 Total Patients Enrolled
1 Trials studying Cardiac Sarcoidosis
1,500 Patients Enrolled for Cardiac Sarcoidosis
David H Birnie, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
3 Previous Clinical Trials
1,725 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on Methotrexate or Prednisone for a health condition.I cannot or do not want to give permission for treatment.I have been treated for sarcoidosis recently, not including creams or ointments.My recent PET scan shows active cancer.I cannot take Methotrexate or Prednisone due to side effects or health reasons.I am a woman of childbearing age and I refuse to use effective birth control during the study.I have heart issues due to sarcoidosis, like irregular heartbeats or weak heart muscles.My CT scan shows signs of sarcoidosis or swollen lymph nodes in my chest.You are currently breastfeeding a baby.There is no other reason for your symptoms that can be easily explained.
Research Study Groups:
This trial has the following groups:- Group 1: Prednisone (or Prednisolone)
- Group 2: Methotrexate
Awards:
This trial has 4 awards, including:- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Could you please list other clinical trials that have used Methotrexate?
"As of now, there are570 clinical trials underway that involve the use of Methotrexate. Out of those, 161 are in Phase 3. The majority of these trials are based in Duarte, California, but there are 21050 locations running trials for this treatment globally."
Answered by AI
Is this clinical trial widely available in the United States?
"There are 15 clinical trial sites across Canada, including St. Joseph's Healthcare Centre in Hamilton, the Montreal Heart Institute in Montreal, and the London Health Sciences Centre in London."
Answered by AI
For what purpose is Methotrexate typically given to patients?
"Methotrexate has been shown to be an effective treatment for thyroiditis, multiple sclerosis, and ulcerative colitis."
Answered by AI
Are there any dangers associated with Methotrexate use?
"There is some evidence from past clinical trials that Methotrexate is effective, as well as multiple rounds of data supporting its safety. This gave it a score of 3."
Answered by AI
Are people presently enrolling in this trial?
"Yes, as indicated by the most recent update on clinicaltrials.gov, this clinical trial is looking for more participants. The study was first posted on 2019-01-15, and the 15 sites aim to enroll a total of 194 patients."
Answered by AI
How many study participants are allowed to enroll in this trial?
"In order to move forward, this study requires 194 individuals that meet the pre-determined inclusion criteria to take part. Patients have the option of participating at sites such as St. Joseph's Healthcare Centre in Hamilton, Ontario and Montreal Heart Institute in Montreal, Quebec."
Answered by AI
Who else is applying?
What site did they apply to?
The Ohio State University Wexner Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been in remission for years, but now I have developed some cardiac symptoms and have a PAP of 40 (by echo) Oct 2023. I also have psoriatric arthritis for which I am reluctantly trying Taltz 80mg Month. Before taking Taltz ~ 6months, I was on and off Prednisone (low dose) which seemed to help with an occasional high dose. I am a retired RN and would like to be helpful in finding the cause and cure of this disease. If I receive relief in the process, that is even better.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- The Ohio State University Wexner Medical Center: < 48 hours
Typically responds via
Email
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